Return to Activity After Surgery for Lumbar Disc Herniation: An Exploratory, Post-Market, Prospective, Randomized, Controlled Trial of an Annular Closure Device
Intrinsic Therapeutics
Summary
RCT investigating postoperative activity restriction after lumbar discectomy in patients treated with annular closure.
Description
The purpose of this prospective, randomized, multicenter study is to determine the reherniation and reoperation rates of patients treated with the annular closure device after standard post-operative restrictions versus patient-determined restrictions.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Skeletally mature (male or female). * Patients with posterior or posterolateral disc herniations at one level between L4 and S1 with radiographic confirmation of neural compression using MRI. \[Note: Intraoperatively, only patients with an annular defect (post discectomy) between 4mm and 6mm tall and 6mm and 10mm wide shall qualify.\] * Minimum posterior disc height of 5mm at the index level. * Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60 degrees)22 (L45, L5S1) * VAS leg pain (one or both legs) of at least 40/100 at baseline * Psyc…
Interventions
- OtherPostoperative therapy
Investigating different postoperative restrictions after lumbar disc herniation surgery
Location
- Spine Institute of LouisianaShreveport, Louisiana