Reduction of radiculopathy and pain with Oxiplex/SP gel after laminectomy, laminotomy, and discectomy: a pilot clinical study.
METHODS
Safety using Oxiplex/SP Gel during single-level discectomy for reduction of symptoms associated with unilateral herniation of the lumbar disc was investigated by self-assessment questionnaire and magnetic resonance imaging.


OBJECTIVE
To evaluate the safety and assess the efficacy parameters of Oxiplex/SP Gel.


BACKGROUND
Animal studies demonstrated that Oxiplex/SP Gel (CMC/PEO) reduced epidural fibrosis after lumbar surgery.


METHODS
Surgeons examined spine and lower extremities of patients scheduled for discectomy to assess neurologic function and pain. Treated patients received sufficient Oxiplex/SP Gel (1-3 mL) to coat the nerve root and fill the epidural space. The control condition was surgery alone. At baseline, then 30 days, 90 days, and 6 months after surgery, patients completed self-assessment questionnaires concerning leg pain, lower extremity weakness, functional disability, daily living activities, symptoms, and radiculopathy. Magnetic resonance imaging was performed at baseline and 90 days after surgery. At 30 and 90 days after surgery, patients underwent physical examination, wound inspection, and laboratory tests.


RESULTS
The surgical procedures were well tolerated by the 23 patients treated with Oxiplex/SP Gel and the 11 control patients. There were no unanticipated adverse events, no clinically significant laboratory results, and no significant differences detected by magnetic resonance imaging. Treated patients had greater reduction in outcome measures at 30 days. The differences in scores were attenuated at 90 days and 6 months. A subgroup, the patients with significant leg pain and weakness at baseline (11 patients treated with Oxiplex/SP Gel and 7 control patients), had greater reduction in outcome measures than the control patients throughout the study.


CONCLUSIONS
Oxiplex/SP Gel was easy to use and safe for patients undergoing unilateral discectomy. Greater benefit in clinical outcome measures was seen in gel-treated patients, especially those with severe leg pain and weakness at baseline.
Kim
Kee D
KD
Department of Neurological Surgery, University of California Davis Medical Center, USA.
Wang
Jeffrey C
JC
Robertson
Daniel P
DP
Brodke
Darrel S
DS
Olson
Erik M
EM
Duberg
Arthur C
AC
BenDebba
Mohammed
M
Block
Kathleen M
KM
diZerega
Gere S
GS
D000328:Adult; D000368:Aged; D002482:Cellulose / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D017586:Diskectomy / Q000009:adverse effects; D005260:Female; D005782:Gels; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000601:surgery*; D007796:Laminectomy / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000209:etiology; D011843:Radiculopathy / Q000188:drug therapy* / Q000209:etiology; D013514:Surgical Procedures, Operative / Q000009:adverse effects; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D005782:Gels; C406630:Oxiplex; D011092:Polyethylene Glycols; D002482:Cellulose