STUDY DESIGN: This was a prospective, randomized, multicenter, double-blind study. OBJECTIVES: The study evaluated the use of ADCON-L Anti-Adhesion Barrier Gel to inhibit peridural fibrosis and reduce fibrosis-related symptoms after first-time lumbar discectomy. SUMMARY OF BACKGROUND DATA: Peridural scarring causes tethering of dura and nerve roots, contributing to pain and functional limitation, and that symptoms are evident by 6 months after surgery. METHODS: Following discectomy, ADCON-L was applied to patients in the active treatment group. Outcome measures were reduction of peridural scar and postoperative pain. RESULTS: There is an association between peridural scar and recurrent radicular pain. Patients having extensive peridural scar were three times more likely to experience recurrent radicular pain than those patients with less extensive scarring. ADCON-L inhibited peridural scar. Compared to the control group, there was a 23% reduction in the number of patients with extensive peridural scar and a 120% increase in the number of patients having minimal or no scar. ADCON-L reduced the incidence of activity-related pain. There was up to a 50% reduction in the number of patients reporting increased pain while doing typical activities of daily living. CONCLUSIONS:ADCON-L is safe, reduces peridural fibrosis, and improves postoperative patient outcome.
RCT Entities:
STUDY DESIGN: This was a prospective, randomized, multicenter, double-blind study. OBJECTIVES: The study evaluated the use of ADCON-L Anti-Adhesion Barrier Gel to inhibit peridural fibrosis and reduce fibrosis-related symptoms after first-time lumbar discectomy. SUMMARY OF BACKGROUND DATA: Peridural scarring causes tethering of dura and nerve roots, contributing to pain and functional limitation, and that symptoms are evident by 6 months after surgery. METHODS: Following discectomy, ADCON-L was applied to patients in the active treatment group. Outcome measures were reduction of peridural scar and postoperative pain. RESULTS: There is an association between peridural scar and recurrent radicular pain. Patients having extensive peridural scar were three times more likely to experience recurrent radicular pain than those patients with less extensive scarring. ADCON-L inhibited peridural scar. Compared to the control group, there was a 23% reduction in the number of patients with extensive peridural scar and a 120% increase in the number of patients having minimal or no scar. ADCON-L reduced the incidence of activity-related pain. There was up to a 50% reduction in the number of patients reporting increased pain while doing typical activities of daily living. CONCLUSIONS: ADCON-L is safe, reduces peridural fibrosis, and improves postoperative patient outcome.
Authors: R B North; J N Campbell; C S James; M K Conover-Walker; H Wang; S Piantadosi; J D Rybock; D M Long Journal: Neurosurgery Date: 1991-05 Impact factor: 4.654