Study Design. Prospective, randomized, blinded clinical trial.
Objective. To evaluate effectiveness of Oxiplex gel for reduction of pain and associated symptoms after lumbar discectomy.
Summary of Background Data. Oxiplex gel (carboxymethylcellulose, polyethylene oxide, and calcium) is used during discectomy to coat the surgical site for reduction of pain and symptoms after lumbar discectomy.
Methods. Patients undergoing single-level lumbar discectomy performed by laminectomy or laminotomy and randomized to receive either surgery plus Oxiplex gel (treatment group) or surgery alone (control group) were assessed 6 months after surgery using (1) a quality of life questionnaire (Lumbar Spine Outcomes Questionnaire [LSOQ]) and (2) clinical evaluations.
Results. There were no statistically significant differences in baseline demographics, surgical procedures, LSOQ scores, and clinical evaluations between treatment (N = 177) and control (N = 175) groups. More gel-treated patients were satisfied with outcome of their surgical treatment than control patients (P = 0.05). The gel-treated group showed greater reductions in pain and symptoms from baseline compared with surgery-only controls. Additional benefits of gel were consistently shown in reduction of leg and back pain at 6 months in the patient population having substantial back pain at baseline (greater than or equal to the median LSOQ pain score of 63). In that population, there was a statistically significant reduction of leg pain and back pain (P < 0.01) in the treatment group compared with controls. Fewer patients in the treatment group had abnormal musculoskeletal physical examinations at 6 months compared with controls. There were no cases of cerebrospinal fluid leaks and no differences in laboratory values or vital signs. Patients in the treatment group had less hypoesthesia, paraesthesia, sensory loss, and fewer reoperations during the 6-month follow-up than controls (1 vs. 6).
Conclusion. These data demonstrate improvements in clinical outcomes resulting from the use of Oxiplex gel in discectomy procedures for treatment of lumbar disc herniation.
Effectiveness of Oxiplex in reducing pain and associated symptoms after single-level lumbar discectomy was assessed 6 months after surgery using quality-of-life measures and clinical evaluations. Leg pain and back pain reduction (P < 0.01) occurred in Oxiplex-treated subjects who had substantial back pain at baseline compared with control subjects.
*OrthoCarolina Spine Center, Charlotte, NC
†Texas Back Institute, Plano, TX
‡Oregon Health Science University, Dept. of Neurosurgery, Portland, OR
§St. Mary's Spine Center, San Francisco, CA
‖University of California Davis School of Medicine, Department of Neurological Surgery, Sacramento, CA;
¶Durango Orthopedic Associates, Durango, CO;
#University of California at Los Angeles Department of Orthopaedic Surgery, Santa Monica, CA;
**Department of Surgery, University of Kansas Medical Center, Kansas City, KS;
††Department of Neurosurgery, Johns Hopkins School of Medicine, Baltimore, MD;
‡‡FzioMed, Inc., San Luis Obispo, CA;
§§R.P. Chiacchierini & Associates, LLC, Rockville, MD;
‖‖Keck-USC School of Medicine, Los Angeles, CA.
Address correspondence and reprint requests to Gere S. diZerega, MD, Keck-USC School of Medicine, 1321 N. Mission Road, Los Angeles, CA, 90033; E-mail: email@example.com
Acknowledgment date: August 20, 2010. First revision date: March 8, 2011. Acceptance date: July 14, 2011.
The device(s)/drug(s) that is/are the subject of this manuscript is/are not intended for human use.
Corporate/Industry funds were received to support this work. One or more of the author(s) has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.