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.

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.