Trial Outcomes & Findings for Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease (NCT NCT00749996)
NCT ID: NCT00749996
Last Updated: 2016-01-28
Results Overview
The endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
165 participants
Primary outcome timeframe
6 Months
Results posted on
2016-01-28
Participant Flow
A total of 7 patients were enrolled but not randomized: 6 were excluded due to eligibility criteria not met, and 1 was excluded due to non-compliance issue.
Participant milestones
| Measure |
Investigational Group
Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.
|
Control Group
Single level herniectomy
Herniectomy: Herniectomy is defined as the "removal of the extruded/protruded/sequestrated disc material". This is done by probing the annulus and disc space and removing all mobile disc fragments.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
71
|
|
Overall Study
6 Weeks Follow-up
|
72
|
67
|
|
Overall Study
3 Months Follow-up
|
72
|
68
|
|
Overall Study
6 Months Follow-up
|
71
|
63
|
|
Overall Study
12 Months Follow-up
|
68
|
60
|
|
Overall Study
24 Months Follow up
|
57
|
58
|
|
Overall Study
COMPLETED
|
57
|
58
|
|
Overall Study
NOT COMPLETED
|
18
|
13
|
Reasons for withdrawal
| Measure |
Investigational Group
Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.
|
Control Group
Single level herniectomy
Herniectomy: Herniectomy is defined as the "removal of the extruded/protruded/sequestrated disc material". This is done by probing the annulus and disc space and removing all mobile disc fragments.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Protocol Violation
|
2
|
3
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Pregnancy
|
0
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease
Baseline characteristics by cohort
| Measure |
Investigational Group
n=75 Participants
Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.
|
Control Group
n=71 Participants
Single level herniectomy
Herniectomy: Herniectomy is defined as the "removal of the extruded/protruded/sequestrated disc material". This is done by probing the annulus and disc space and removing all mobile disc fragments.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 10 • n=99 Participants
|
40.7 years
STANDARD_DEVIATION 10.7 • n=107 Participants
|
41.0 years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsThe endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset.
Outcome measures
| Measure |
Investigational Group
n=68 Participants
Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.
|
Control Group
n=63 Participants
Single level herniectomy
Herniectomy: Herniectomy is defined as the "removal of the extruded/protruded/sequestrated disc material". This is done by probing the annulus and disc space and removing all mobile disc fragments.
|
|---|---|---|
|
To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS).
|
-3.97 units on a scale
Standard Deviation 2.55
|
-3.37 units on a scale
Standard Deviation 3.15
|
SECONDARY outcome
Timeframe: 12 MonthsThe endpoint will be the difference between baseline and 12 months of the patient's score on the Oswestry Disability Index (ODI). The ODI is a low back pain disability questionnaire used to measure a patient's permanent functional disability in a scale from 0 to 50 (when all the 10 sections are answered); large ODI scores indicate large disability.
Outcome measures
| Measure |
Investigational Group
n=68 Participants
Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.
|
Control Group
n=61 Participants
Single level herniectomy
Herniectomy: Herniectomy is defined as the "removal of the extruded/protruded/sequestrated disc material". This is done by probing the annulus and disc space and removing all mobile disc fragments.
|
|---|---|---|
|
To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI).
|
-38.55 patient's score
Standard Deviation 20.10
|
-37.19 patient's score
Standard Deviation 22.61
|
Adverse Events
Investigational Group
Serious events: 15 serious events
Other events: 44 other events
Deaths: 0 deaths
Control Group
Serious events: 19 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Investigational Group
n=73 participants at risk
Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.
|
Control Group
n=71 participants at risk
Single level herniectomy
Herniectomy: Herniectomy is defined as the "removal of the extruded/protruded/sequestrated disc material". This is done by probing the annulus and disc space and removing all mobile disc fragments.
|
|---|---|---|
|
Cardiac disorders
CARDIOMYOPATHY
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Gastrointestinal disorders
ANAL FISTULA
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
General disorders
ACCIDENTAL DEATH
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Infections and infestations
WOUND INFECTION
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.1%
3/73 • Number of events 3 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
5.6%
4/71 • Number of events 5 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
2.8%
2/71 • Number of events 2 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.5%
4/73 • Number of events 4 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
8.5%
6/71 • Number of events 6 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
2.8%
2/71 • Number of events 3 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Nervous system disorders
VIITH NERVE PARALYSIS
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
Other adverse events
| Measure |
Investigational Group
n=73 participants at risk
Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.
|
Control Group
n=71 participants at risk
Single level herniectomy
Herniectomy: Herniectomy is defined as the "removal of the extruded/protruded/sequestrated disc material". This is done by probing the annulus and disc space and removing all mobile disc fragments.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.5%
4/73 • Number of events 4 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
26.0%
19/73 • Number of events 19 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
28.2%
20/71 • Number of events 25 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
5.5%
4/73 • Number of events 4 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
2.8%
2/71 • Number of events 2 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
24.7%
18/73 • Number of events 18 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
15.5%
11/71 • Number of events 12 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Nervous system disorders
SCIATICA
|
5.5%
4/73 • Number of events 4 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
2.8%
2/71 • Number of events 2 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Cardiac disorders
CARDIAC VALVE DISEASE
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Ear and labyrinth disorders
TINNITUS
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Eye disorders
VISION BLURRED
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
4.1%
3/73 • Number of events 3 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
2.8%
2/71 • Number of events 2 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
General disorders
IMPAIRED HEALING
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Infections and infestations
BRONCHITIS
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Injury, poisoning and procedural complications
DURAL TEAR
|
4.1%
3/73 • Number of events 3 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
4.2%
3/71 • Number of events 3 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Investigations
GASTRIC PH DECREASED
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DISORDER
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
2.8%
2/71 • Number of events 2 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SWELLING
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
OSTEOCHONDROSIS
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROTIC FRACTURE
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Nervous system disorders
BALANCE DISORDER
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Nervous system disorders
DIZZINESS
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Nervous system disorders
DYSAESTHESIA
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Nervous system disorders
HYPOTONIA
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Nervous system disorders
PARAESTHESIA
|
2.7%
2/73 • Number of events 2 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Psychiatric disorders
DEPRESSION
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Renal and urinary disorders
STRESS URINARY INCONTINENCE
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Reproductive system and breast disorders
PROSTATISM
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Vascular disorders
HAEMORRHAGE
|
0.00%
0/73 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
1.4%
1/71 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
|
Vascular disorders
THROMBOPHLEBITIS
|
1.4%
1/73 • Number of events 1 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
0.00%
0/71 • 2 years
For safety analyses, the "As-Treated" population has been used as the primary analysis dataset. In this analysis, a patient was grouped as investigational group (implanted with a DIAM device) or control group according to the true treatment the patient has received, regardless of randomization.
|
Additional Information
Irène Ayer, Clinical research specialist
Medtronic Spinal & Biologics
Phone: +41 21 803 84 27
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60