Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy.

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.

A modern biomaterial for adhesion prevention.

A biomaterial composed of carboxymethylcellulose, poly(ethylene oxide), and calcium can be prepared in a variety of ways to reduce fibrin deposition and adhesion formation. This biomaterial platform can be formulated into a flowable gel with tissue adherence appropriate for use in minimally invasive surgery. The device remains at the site of placement even in gravitationally dependent areas. A peridural formulation was shown in preclinical studies to be safe and effective in reducing adhesions to dura following spinal surgery. A peritoneal formulation used on pelvic organs following peritoneal cavity surgery was also shown to be safe and effective. A clinical feasibility study showed that patients with severe back pain and lower extremity weakness treated with the peridural formulation, applied over their nerve roots following laminectomy or laminotomy, experienced significantly reduced symptoms when compared with surgery-only controls. The peritoneal formulation was shown in two multicenter feasibility studies of women undergoing pelvic surgery to significantly reduce adhesion formation when compared with surgery-only controls. Confirmation of the feasibility studies awaits results from pivotal clinical trials. These formulations were safe, effective, and easy to use. This biomaterial provided a benefit to patients undergoing surgery where postsurgical adhesion formation is a concern.

Reduction of leg pain and lower-extremity weakness for 1 year with Oxiplex/SP gel following laminectomy, laminotomy, and discectomy.

OBJECT: Although good surgical technique is effective in reducing postoperative epidural fibrosis, compression or tethering of the nerve root may cause recurrent radicular pain and physical impairment. The implantation of a bioresorbable gel on the dura may further decrease the amount of scar formation after surgery and thus improve the patient's ability to perform activities of daily living (ADL). This study is a 12-month evaluation of the safety and effectiveness of Oxiplex/SP Gel (FzioMed, Inc., San Luis Obispo, CA) in the reduction of pain and radiculopathy after lumbar discectomy. METHODS: A pilot randomized single-blind multicenter clinical trial was conducted to evaluate the performance of Oxiplex/SP Gel in patients who underwent surgery for unilateral herniation of the lumbar disc at L4-5 or L5-S1. Eighteen patients with severe leg pain and lower-extremity weakness (11 women and seven men) were randomly assigned intraoperatively to receive the gel at the conclusion of surgery (treatment group) or to undergo surgery alone (control group). Self-assessment questionnaires (Lumbar Spine Outcomes Questionnaire) to assess pain, symptoms, and ADL were completed preoperatively and at scheduled postoperative intervals (30 days, 90 days, 6 months, and 12 months). The authors examined the spine and lower extremities of patients scheduled for discectomy to assess neurological function and pain. Treated patients received sufficient Oxiplex/SP Gel (1-3 ml) to coat the nerve root and fill the epidural space. Postoperative clinical evaluations were performed at 30 and 90 days. Patients completed the self-assessment questionnaires at baseline and were contacted by telephone or mail for the completion of the postoperative self-assessment questionnaires. Surgical procedures were well tolerated; no device-related adverse events and no clinically significant laboratory results were reported. The 11 patients with severe leg pain and lower-extremity weakness who were treated with Oxiplex/SP Gel had a reduction in those symptoms at 30 days, 90 days, 6 months, and 12 months after discectomy, compared with the seven control patients who underwent surgery only. CONCLUSIONS: Oxiplex/SP Gel was easy to use and safe in patients who underwent unilateral discectomy. A greater benefit in clinical outcome measures was seen over the 12-month follow-up period in gel-treated patients.

Reduction of radiculopathy and pain with Oxiplex/SP gel after laminectomy, laminotomy, and discectomy: a pilot clinical study.

STUDY DESIGN: 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. SUMMARY OF BACKGROUND DATA: 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.