Trial Outcomes & Findings for Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer (NCT NCT01323387)
NCT ID: NCT01323387
Last Updated: 2018-01-16
Results Overview
CT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success.
COMPLETED
NA
178 participants
24 Months
2018-01-16
Participant Flow
Participant milestones
| Measure |
Treatment
Interbody fusions with Anterior Plating
|
|---|---|
|
Overall Study
STARTED
|
178
|
|
Overall Study
COMPLETED
|
94
|
|
Overall Study
NOT COMPLETED
|
84
|
Reasons for withdrawal
| Measure |
Treatment
Interbody fusions with Anterior Plating
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
41
|
|
Overall Study
Radiographic Data Unavailable
|
1
|
|
Overall Study
Revision
|
14
|
|
Overall Study
Protocol Violation
|
12
|
|
Overall Study
Randomized but Never Treated
|
16
|
Baseline Characteristics
Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer
Baseline characteristics by cohort
| Measure |
Treatment
n=150 Participants
Interbody fusions with Anterior Plating
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
150 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 9.29 • n=99 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24 MonthsCT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success.
Outcome measures
| Measure |
Treatment
n=94 Participants
Interbody fusions with Anterior Plating
|
|---|---|
|
Number of Subjects With Successful Radiographic Fusion
|
90 Participants
|
SECONDARY outcome
Timeframe: 24 MonthsQuality of Life using the SF-12 Scale Physical Health Component Score (PCS). The PCS is a measurement of health status with a range of 0-100. A higher score indicates less disability.
Outcome measures
| Measure |
Treatment
n=92 Participants
Interbody fusions with Anterior Plating
|
|---|---|
|
Quality of Life Using the SF-12 Scale Physical Health Component Score (PCS). Number of Subjects Who Achieved 15% Improvement in PCS Compared to Baseline.
|
57 Participants
|
SECONDARY outcome
Timeframe: Baseline and 24 MonthsThe Numeric Rating Scale (NRS) is a measurement of pain from a value of 0 (no pain) to a value of 10 (worst pain)
Outcome measures
| Measure |
Treatment
n=91 Participants
Interbody fusions with Anterior Plating
|
|---|---|
|
Pain Scores on the Numeric Rating Scale (NRS)
NRS at Baseline
|
8.0 units on a scale
Standard Deviation 1.7
|
|
Pain Scores on the Numeric Rating Scale (NRS)
NRS at 24 Months
|
4.6 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 24 MonthsThe outcome measure is the number of subjects who achieved a 15% improvement in ODI compared to baseline. The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. ODI scores range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible
Outcome measures
| Measure |
Treatment
n=92 Participants
Interbody fusions with Anterior Plating
|
|---|---|
|
Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline
|
63 Participants
|
SECONDARY outcome
Timeframe: Baseline and 24 MonthsThe outcome measure is the number of subjects who achieved a 15% improvement in MCS compared to baseline. The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.
Outcome measures
| Measure |
Treatment
n=92 Participants
Interbody fusions with Anterior Plating
|
|---|---|
|
Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline
|
42 Participants
|
SECONDARY outcome
Timeframe: Baseline and 24 MonthsThe PCS (Physical Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.
Outcome measures
| Measure |
Treatment
n=92 Participants
Interbody fusions with Anterior Plating
|
|---|---|
|
SF-12 Physical Composite Score (PCS) Summary
PCS at Baseline
|
29.4 Units on a scale
Standard Deviation 7.0
|
|
SF-12 Physical Composite Score (PCS) Summary
PCS at 24 Months
|
38.9 Units on a scale
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: Baseline and 24 MonthsThe MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.
Outcome measures
| Measure |
Treatment
n=92 Participants
Interbody fusions with Anterior Plating
|
|---|---|
|
SF-12 Mental Composite Score (MCS) Summary
MCS at Baseline
|
38.2 Units on a scale
Standard Deviation 11.7
|
|
SF-12 Mental Composite Score (MCS) Summary
MCS at 24 Months
|
45.6 Units on a scale
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Baseline and 24 MonthsThe Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The scores can range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible
Outcome measures
| Measure |
Treatment
n=92 Participants
Interbody fusions with Anterior Plating
|
|---|---|
|
Oswestry Disability Index (ODI) Summary
ODI at Baseline
|
53.3 Units on a scale
Standard Deviation 13.7
|
|
Oswestry Disability Index (ODI) Summary
ODI at 24 Months
|
31.8 Units on a scale
Standard Deviation 23.0
|
Adverse Events
Treatment
Serious adverse events
| Measure |
Treatment
n=150 participants at risk
Interbody fusions with Anterior Plating
|
|---|---|
|
Injury, poisoning and procedural complications
Broken Components
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Device Slippage
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
New Onset of Pain
|
4.0%
6/150 • Number of events 6 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pseudoarthrosis
|
6.7%
10/150 • Number of events 10 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Damage
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Vascular disorders
Thrombophlebitis
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Vascular disorders
Vascular Injury
|
1.3%
2/150 • Number of events 2 • 24 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Disc Fragment Dislodged
|
0.67%
1/150 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Treatment
n=150 participants at risk
Interbody fusions with Anterior Plating
|
|---|---|
|
Nervous system disorders
New Onset of Pain
|
25.3%
38/150 • Number of events 54 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pseudoarthrosis
|
11.3%
17/150 • Number of events 17 • 24 months
|
|
Vascular disorders
Vascular Injury
|
4.7%
7/150 • Number of events 7 • 24 months
|
|
Nervous system disorders
Numbness/Tingling Sensation
|
3.3%
5/150 • Number of events 6 • 24 months
|
|
Injury, poisoning and procedural complications
Broken Components
|
4.0%
6/150 • Number of events 7 • 24 months
|
|
Infections and infestations
Infection
|
2.7%
4/150 • Number of events 4 • 24 months
|
|
Nervous system disorders
Neural Structure Injury
|
2.7%
4/150 • Number of events 4 • 24 months
|
|
Vascular disorders
Thrombosis/Thrombophlegitis
|
2.0%
3/150 • Number of events 3 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Adjacent Segment Degeneration
|
1.3%
2/150 • Number of events 2 • 24 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cysts Found in and around Spacer
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Product Issues
Device Slippage
|
1.3%
2/150 • Number of events 2 • 24 months
|
|
Injury, poisoning and procedural complications
Disc Fragment Dislodged
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
General disorders
Edema
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Fracture of Vertebrae
|
1.3%
2/150 • Number of events 2 • 24 months
|
|
Blood and lymphatic system disorders
Hematoma/Seroma
|
1.3%
2/150 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
ileus
|
1.3%
2/150 • Number of events 2 • 24 months
|
|
General disorders
Insomnia
|
1.3%
2/150 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Intestinal Blockage
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Reproductive system and breast disorders
Irregular Menstrual Cycle
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
1.3%
2/150 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Vascular disorders
Phlebitis
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Reproductive system and breast disorders
Retrograde Ejaculation
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Damage
|
0.67%
1/150 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.67%
1/150 • Number of events 1 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60