Oxiplex Improves Outcomes After Lumbar Discectomy
Gel treatment linked to greater reductions in pain, symptoms; satisfaction with surgical procedure
TUESDAY, April 24 (HealthDay News) -- The use of Oxiplex gel (containing carboxymethylcellulose, polyethylene oxide, and calcium) to coat the surgical site during discectomy procedures for the treatment of lumbar disc herniation is associated with improved clinical outcomes, according to a study published in the April 15 issue of Spine.
Alfred L. Rhyne, M.D., of the OrthoCarolina Spine Center in Charlotte, N.C., and colleagues conducted a prospective, randomized, blinded clinical trial involving 177 patients who received Oxiplex gel following lumbar discectomy and 175 surgery-only control patients. Patients completed the Lumbar Spine Outcomes Questionnaire to assess quality of life, and underwent clinical evaluations at six months post-surgery.
The researchers found that, compared with control patients, more gel-treated patients were satisfied with the outcome of their surgery. Greater reductions in pain and symptoms were seen for gel-treated versus control patients. In a subgroup of patients with substantial back pain at baseline, gel-treatment was associated with a significant and consistent reduction in leg and back pain at six months. Compared with controls, fewer gel-treated patients had abnormal musculoskeletal physical examinations at six months. Fewer gel-treated patients reported hypoesthesia, paraesthesia, sensory loss, or reoperations during the six-month follow-up period.
"These data demonstrate multiple improvements in clinical outcome compared with that achieved by surgery alone due to the addition of Oxiplex gel to discectomy for treatment of lumbar herniation," the authors write.
The study was supported by corporate/industry funds; several authors disclosed potential financial conflicts of interest, including financial ties to FzioMed, the manufacturer of Oxiplex gel.