Inhibition of epidural fibrosis with ADCON-L: effect on clinical outcome one year following re-operation for recurrent lumbar radiculopathy.
In a prospective multicenter study, 20 patients underwent re-operation for recurrent radiculopathy after lumbo-sacral discectomy, and were treated with ADCON-L (Adhesion Control in a Barrier Gel) to inhibit epidural fibrosis following secondary surgery. Outcomes after re-operation were assessed at six and 12 months using: Visual Analog Scales to measure radicular and back pain, straight leg raising exams, and self-assessment of activity-related radicular pain. Each parameter was compared to baseline values, obtained immediately prior to the re-operation. The long term clinical results at 12 months after re-operation (summarized below) demonstrate a significant improvement of all clinical parameters, and correlated with the results seen at six months. Radicular pain, measured when most severe, was reduced from an average pre-operative score of 8.1-3.7 (p < 0.005). The straight leg raising angle increased from an average pre-operative value of 41 degrees-67 degrees (p < 0.005). Activity-related pain mean score was 4.6, vs. 17.0 pre-operatively (p < 0.005). Low back pain, measured when most severe, was reduced from an average pre-operative score of 6.1 to 3.1 (p < 0.012). These clinical findings compare very favorably with data reported in the literature. There were no adverse events or complications related to the use of ADCON-L.
Porchet
F
F
Service de Neurochirurgie, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Lombardi
D
D
de Preux
J
J
Pople
I K
IK
D000328:Adult; D017586:Diskectomy / Q000009:adverse effects*; D004824:Epidural Space; D005260:Female; D005355:Fibrosis / Q000517:prevention & control; D005500:Follow-Up Studies; D005782:Gels / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009930:Organic Chemicals; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D012008:Recurrence; D012086:Reoperation; D013126:Spinal Nerve Roots / Q000187:drug effects*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
C104199:ADCON-L; D005782:Gels; D009930:Organic Chemicals