Reduction in leg pain and lower-extremity weakness with Oxiplex/SP Gel for 1 year after laminectomy, laminotomy, and discectomy

Abstract

<jats:sec> <jats:title>Object</jats:title> <jats:p>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.</jats:p></jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>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).</jats:p> <jats:p>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.</jats:p> <jats:p>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.</jats:p></jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>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.</jats:p></jats:sec>

Original article Nanofiber nets in prevention of cicatrisation in spinal procedures. Experimental study

“…However, clinical observation has not demonstrated any positive effects of these formulations in the postoperative period. Furthermore, Oxiplex is contraindicated whenever intraoperative liquorrhea is suspected [20,21,35]. The use of synthetic hydrogel (DSX) to form an antiadhesion barrier is a relatively new approach.…”

“…MRI provides precise visuali zation of scar tissue. In approximately 24% of patients after spinal canal surgery, the radiological eva lu ation shows a scar surrounding and infiltrating The materials used in the prevention of cicatrisation in human surgery include polytetrafluoroethylene, autogenous adipose tissue, protein polymers, hyaluronate, Adcon-L, Oxiplex/Sp, DuraGen, and DuraSeal Xact Adhesion Barrier (DSX) [10,11,12,16,18,20,21]. These products are currently available and used throughout the world.…”

Reduction in postlaminectomy epidural adhesions in sheep using a fibrin sealant‐based medicated adhesion barrier

“…Similar discrepancies have previously been reported in clinical studies investigating the antiadhesive effects of a new synthetic gel, Oxiplex 1 /SP Gel, where MR images revealed no significant differences between treated and untreated patients although a clear reduction in postoperative pain score was evident after administration of the gel. 3,47 In addition to preventing epidural scar formation, several other criteria need to be considered when evaluating the suitability of antiadhesive agents for use in spinal surgery. Compromised healing of dural tears and spontaneous CSF leaks are considered to be major concerns as indicated by the complications associated with ADCON-L 1 , where persistent CSF leakage was reported in several patients due to delayed healing of dural tears.…”

Prevention of anterior scar formation following discectomy with a medishield adhesion barrier: randomized experimental trial

“…In addition to the development of meticulous surgical techniques, many types of materials have been tested in the epidural space in an effort to reduce scar formation (11). However, the interposition materials that have been used in humans to prevent scar formation, such as gelfoam and fat grafts (9,15), have only addressed posterior scar formation and do little to inhibit anterior fibrosis (27).…”