Trial Outcomes & Findings for Study of SyntheCelTM Dura Replacement to Other Dura Replacements (NCT NCT00859508)
NCT ID: NCT00859508
Last Updated: 2012-03-08
Results Overview
The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
6 months
Results posted on
2012-03-08
Participant Flow
The trial was approved to enroll subjects from a maximum of 10 US medical institutions (public and academic research center hospitals). Subjects were enrolled from February 2006 to June 2008.
A total of 105 patients that initially met the inclusion/exclusion criteria were enrolled and randomized. Of those 105 patients, 99 received surgical treatment. Of those not treated, reasons included: change in diagnosis, not meeting Inclusion/Exclusion criteria, subject voluntary withdrawl, and investigator decision.
Participant milestones
| Measure |
SyntheCel
The investigational group consists of patients who received the SyntheCel Dura Replacement device.
|
Other FDA Cleared Dura Replacements
The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
37
|
|
Overall Study
COMPLETED
|
62
|
37
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of SyntheCelTM Dura Replacement to Other Dura Replacements
Baseline characteristics by cohort
| Measure |
SyntheCel
n=68 Participants
The investigational group consists of patients who received the SyntheCel Dura Replacement device.
|
Other FDA Cleared Dura Replacements
n=37 Participants
The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age Continuous
|
46.5 years
STANDARD_DEVIATION 12.85 • n=99 Participants
|
48.6 years
STANDARD_DEVIATION 14.03 • n=107 Participants
|
47.2 years
STANDARD_DEVIATION 13.25 • n=206 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=99 Participants
|
37 participants
n=107 Participants
|
105 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site.
Outcome measures
| Measure |
SyntheCel
n=59 Participants
The investigational group consists of patients who received the SyntheCel Dura Replacement device.
|
Other FDA Cleared Dura Replacements
n=34 Participants
The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
|
|---|---|---|
|
Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele
|
57 participants
|
33 participants
|
SECONDARY outcome
Timeframe: up to 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsRadiographic evaluation (to determine the presence or absence of the following at the 6 month follow-up visit) * Adhesion formation * Membrane formation * Abnormal thickening along graft (device implant) site * Brain edema adjacent to graft (device implant) site
Outcome measures
Outcome data not reported
Adverse Events
SyntheCel
Serious events: 23 serious events
Other events: 57 other events
Deaths: 0 deaths
Other FDA Cleared Dura Replacements
Serious events: 9 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SyntheCel
n=62 participants at risk
The investigational group consists of patients who received the SyntheCel Dura Replacement device.
|
Other FDA Cleared Dura Replacements
n=37 participants at risk
The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
3.2%
2/62
|
0.00%
0/37
|
|
Nervous system disorders
BRAIN EDEMA
|
3.2%
2/62
|
0.00%
0/37
|
|
Cardiac disorders
CARDIOVASCULAR
|
0.00%
0/62
|
2.7%
1/37
|
|
Nervous system disorders
CSF LEAK
|
3.2%
2/62
|
0.00%
0/37
|
|
General disorders
DEATH
|
0.00%
0/62
|
2.7%
1/37
|
|
Injury, poisoning and procedural complications
DRUG REACTION
|
1.6%
1/62
|
0.00%
0/37
|
|
Gastrointestinal disorders
GASTROINTESTINAL
|
3.2%
2/62
|
0.00%
0/37
|
|
General disorders
HEADACHE
|
3.2%
2/62
|
0.00%
0/37
|
|
Vascular disorders
HEMORRHAGE
|
1.6%
1/62
|
0.00%
0/37
|
|
Nervous system disorders
HYDROCEPHALUS
|
3.2%
2/62
|
2.7%
1/37
|
|
Infections and infestations
INFECTION-OTHER
|
1.6%
1/62
|
0.00%
0/37
|
|
Infections and infestations
INFECTION-SURGICAL SITE DEEP
|
1.6%
1/62
|
0.00%
0/37
|
|
Infections and infestations
INFECTION-SURGICAL SITE SUPERFICIAL
|
1.6%
1/62
|
2.7%
1/37
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL
|
1.6%
1/62
|
0.00%
0/37
|
|
Nervous system disorders
NEUROLOGICAL
|
11.3%
7/62
|
2.7%
1/37
|
|
General disorders
PAIN
|
1.6%
1/62
|
0.00%
0/37
|
|
Nervous system disorders
PARESTHESIA
|
1.6%
1/62
|
2.7%
1/37
|
|
Psychiatric disorders
PSYCHOLOGICAL
|
1.6%
1/62
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY
|
1.6%
1/62
|
0.00%
0/37
|
|
Nervous system disorders
SEIZURE
|
3.2%
2/62
|
5.4%
2/37
|
|
Vascular disorders
STROKE
|
3.2%
2/62
|
2.7%
1/37
|
|
Surgical and medical procedures
SURGERY-OTHER
|
3.2%
2/62
|
5.4%
2/37
|
|
Surgical and medical procedures
SURGERY-REOPERATION (INDEX SITE)
|
3.2%
2/62
|
0.00%
0/37
|
Other adverse events
| Measure |
SyntheCel
n=62 participants at risk
The investigational group consists of patients who received the SyntheCel Dura Replacement device.
|
Other FDA Cleared Dura Replacements
n=37 participants at risk
The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
1.6%
1/62
|
2.7%
1/37
|
|
Nervous system disorders
BRAIN EDEMA
|
0.00%
0/62
|
2.7%
1/37
|
|
Cardiac disorders
CARDIOVASCULAR
|
8.1%
5/62
|
18.9%
7/37
|
|
Nervous system disorders
CSF LEAK
|
1.6%
1/62
|
0.00%
0/37
|
|
General disorders
DEATH
|
0.00%
0/62
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGICAL
|
11.3%
7/62
|
2.7%
1/37
|
|
Eye disorders
DIPLOPIA
|
1.6%
1/62
|
5.4%
2/37
|
|
General disorders
DIZZINESS
|
16.1%
10/62
|
5.4%
2/37
|
|
Injury, poisoning and procedural complications
DRUG REACTION
|
14.5%
9/62
|
16.2%
6/37
|
|
General disorders
EDEMA
|
21.0%
13/62
|
8.1%
3/37
|
|
General disorders
FATIGUE
|
14.5%
9/62
|
5.4%
2/37
|
|
Infections and infestations
FEVER
|
6.5%
4/62
|
2.7%
1/37
|
|
Gastrointestinal disorders
GASTROINTESTINAL
|
29.0%
18/62
|
29.7%
11/37
|
|
Renal and urinary disorders
GENITOURINARY
|
1.6%
1/62
|
0.00%
0/37
|
|
General disorders
HEADACHE
|
40.3%
25/62
|
29.7%
11/37
|
|
Vascular disorders
HEMATOMA
|
1.6%
1/62
|
2.7%
1/37
|
|
Vascular disorders
HEMORRHAGE
|
0.00%
0/62
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
3.2%
2/62
|
0.00%
0/37
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.00%
0/62
|
0.00%
0/37
|
|
Infections and infestations
INFECTION-OTHER
|
4.8%
3/62
|
8.1%
3/37
|
|
Infections and infestations
INFECTION-SURGICAL SITE DEEP
|
0.00%
0/62
|
0.00%
0/37
|
|
Infections and infestations
INFECTION-SURGICAL SITE SUPERFICIAL
|
3.2%
2/62
|
2.7%
1/37
|
|
General disorders
INSOMNIA
|
6.5%
4/62
|
5.4%
2/37
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL
|
12.9%
8/62
|
10.8%
4/37
|
|
Nervous system disorders
NEUROLOGICAL
|
43.5%
27/62
|
37.8%
14/37
|
|
General disorders
OTHER
|
25.8%
16/62
|
13.5%
5/37
|
|
General disorders
PAIN
|
19.4%
12/62
|
35.1%
13/37
|
|
Skin and subcutaneous tissue disorders
PAIN-INCISION
|
11.3%
7/62
|
13.5%
5/37
|
|
Nervous system disorders
PARATHESIA
|
6.5%
4/62
|
8.1%
3/37
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
4.8%
3/62
|
2.7%
1/37
|
|
Psychiatric disorders
PSYCHOLOGICAL
|
8.1%
5/62
|
13.5%
5/37
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY
|
4.8%
3/62
|
10.8%
4/37
|
|
Nervous system disorders
SEIZURE
|
4.8%
3/62
|
0.00%
0/37
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEROMA
|
4.8%
3/62
|
2.7%
1/37
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
1.6%
1/62
|
0.00%
0/37
|
|
Vascular disorders
STROKE
|
0.00%
0/62
|
0.00%
0/37
|
|
Vascular disorders
SUBDURAL HEMATOMA
|
1.6%
1/62
|
2.7%
1/37
|
|
Surgical and medical procedures
SURGERY-REOPERATION (INDEX SITE)
|
0.00%
0/62
|
0.00%
0/37
|
|
Vascular disorders
THROMBOSIS
|
1.6%
1/62
|
0.00%
0/37
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
3.2%
2/62
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
WOUND ISSUES-OTHER
|
9.7%
6/62
|
10.8%
4/37
|
|
Surgical and medical procedures
SURGERY-OTHER
|
0.00%
0/62
|
0.00%
0/37
|
Additional Information
Heidi Hausner, Clinical Research Manager
Synthes USA HQ, Inc.
Phone: 610-719-5707
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60