Adhesions, Spinal Injuries
Conditions
Brief summary
To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group receiving standard care.
Detailed description
For more information, please visit www.DuragenStudy.com
Interventions
DEVICEDuraGen Plus Adhesion Barrier Matrix
Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery
Sponsors
Integra LifeSciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
(Abstracted from clinical protocol): * Patients with radicular pain requiring single-level, lumbar hemi-laminectomy or hemilaminotomy procedures with discectomy in the lower lumbar spine * Require initial open lumbar surgery for extruded, prolapsed or bulging intervertebral discs * Requires removal of herniated disc fragment
Exclusion criteria
(Abstracted from clinical protocol): * Current or historic open traumatic injury to the spine * Any previous surgery to the lumbar spine or percutaneous tissue destruction or ablation procedures * Women who are nursing, women who are pregnant and women who are planning to become pregnant during the time of the study * Any spinal conditions or systemic diseases that would preclude the patient from participation in the clinical trial * Clinically significant structural disorders * Known positive for HIV * Insulin-dependent Diabetes Mellitus patients * Morbid obesity (Body Mass Index greater than or equal to 40 kg/m2) * History of alcohol or drug abuse within 2 years prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological, Pain, and Functional Outcome Assessments | 6 months | Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage). Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain. Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))\*100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiological, Pain, and Functional Outcome Assessments | 12 months | Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage). Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain. Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))\*100. |
Countries
United States
Participant flow
Pre-assignment details
A total of 343 patients were randomized in the study (Intent-to-treat population). Four patients received treatment (1 Duragen Plus; 3 Surgery alone), but were not randomized correctly, and were followed-up for safety only. Hence the total patients in the Safety Population is 347.
Participants by arm
| Arm | Count |
|---|---|
| 1- DuraGen Plus During Surgery Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine | 177 |
| 2 - Surgery Alone Control arm is surgery alone (no adhesion barrier) | 166 |
| Total | 343 |
Baseline characteristics
| Characteristic | 2 - Surgery Alone | 1- DuraGen Plus During Surgery | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 6 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 162 Participants | 171 Participants | 333 Participants |
| Age, Continuous | 43.3 years STANDARD_DEVIATION 11.27 | 42.7 years STANDARD_DEVIATION 11.38 | 43.0 years STANDARD_DEVIATION 11.31 |
| Region of Enrollment United States | 166 participants | 177 participants | 343 participants |
| Sex: Female, Male Female | 74 Participants | 76 Participants | 150 Participants |
| Sex: Female, Male Male | 92 Participants | 101 Participants | 193 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 100 / 178 | 106 / 169 |
| serious Total, serious adverse events | 18 / 178 | 19 / 169 |
Outcome results
Primary
Radiological, Pain, and Functional Outcome Assessments
Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage). Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain. Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))\*100.
Time frame: 6 months
Population: Data reported for patients evaluable at 6 months.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 1- DuraGen Plus During Surgery | Radiological, Pain, and Functional Outcome Assessments | MRI Outcome Score | 12.375 Outcome scores | Standard Error 0.499 |
| 1- DuraGen Plus During Surgery | Radiological, Pain, and Functional Outcome Assessments | ODI Score | 6.974 Outcome scores | Standard Error 0.629 |
| 1- DuraGen Plus During Surgery | Radiological, Pain, and Functional Outcome Assessments | VAS Score | 14.010 Outcome scores | Standard Error 1.61 |
| 2 - Surgery Alone | Radiological, Pain, and Functional Outcome Assessments | MRI Outcome Score | 12.578 Outcome scores | Standard Error 0.517 |
| 2 - Surgery Alone | Radiological, Pain, and Functional Outcome Assessments | ODI Score | 7.118 Outcome scores | Standard Error 0.639 |
| 2 - Surgery Alone | Radiological, Pain, and Functional Outcome Assessments | VAS Score | 16.696 Outcome scores | Standard Error 1.646 |
Secondary
Radiological, Pain, and Functional Outcome Assessments
Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage). Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain. Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))\*100.
Time frame: 12 months
Population: Data reported for patients evaluable at 12 months.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 1- DuraGen Plus During Surgery | Radiological, Pain, and Functional Outcome Assessments | MRI Outcome Score | 10.046 Outcome scores | Standard Error 0.519 |
| 1- DuraGen Plus During Surgery | Radiological, Pain, and Functional Outcome Assessments | ODI Score | 6.048 Outcome scores | Standard Error 0.625 |
| 1- DuraGen Plus During Surgery | Radiological, Pain, and Functional Outcome Assessments | VAS Score | 12.926 Outcome scores | Standard Error 1.612 |
| 2 - Surgery Alone | Radiological, Pain, and Functional Outcome Assessments | MRI Outcome Score | 9.788 Outcome scores | Standard Error 0.534 |
| 2 - Surgery Alone | Radiological, Pain, and Functional Outcome Assessments | ODI Score | 6.890 Outcome scores | Standard Error 0.633 |
| 2 - Surgery Alone | Radiological, Pain, and Functional Outcome Assessments | VAS Score | 14.378 Outcome scores | Standard Error 1.633 |