Peridural scar and its relation to clinical outcome: a randomised study on surgically treated lumbar disc herniation patients.

A prospective randomised 2-year follow-up study on patients undergoing lumbar disc herniation surgery. The objective was to investigate the relationship between peridural scarring and clinical outcome, the scar development 6 and 24 months postoperatively by using MRI, and if ADCON-L (a bioresorbable carbohydrate polymer gel) has an effect on scar size and/or improve patients' outcome after lumbar disc herniation surgery. The association between peridural scarring and recurrent pain after lumbar disc herniation surgery is debated. Numerous materials have been used in attempts to prevent or reduce postoperative peridural scarring; however, there are conflicting data regarding the clinical effects. The study included 119 patients whose mean age was 39 years (18-66); 51 (47%) were women. Sixty patients (56%) were perioperatively randomised to receive ADCON-L, and 48 (44%) served as controls. All patients underwent MRI at 6 and 24 months postoperatively, and an independent radiologist graded the size, location and development of the scar, by using a previously described scoring system. Pre- and 2-year postoperatively patients graded their leg pain on a visual analogue scale (VAS). At the 2-year follow-up patients rated their satisfaction with treatment (subjective outcome) and were evaluated by an independent neurologist (objective outcome), using MacNab score. There was no relationship between size or localisation of the scar and any of the clinical outcomes (VAS, subjective and objective outcome). The scar size decreased between 6 and 24 months in 49%, was unchanged in 42% and increased in 9% of the patients. Patients treated with ADCON-L did not demonstrate any adverse effects, nor did they demonstrate less scarring or better clinical outcome than control patients. No significant association between the presence of extensive peridural scar or localisation of scar formation and clinical outcome could be detected in the present study. Further, no positive or negative effects of ADCON-L used in disc herniation surgery could be seen.

RCT Entities:   Population Interventions Outcomes