Return to Activity After Surgery for Lumbar Disc Herniation
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorIntrinsic Therapeutics
About this trial
RCT investigating postoperative activity restriction after lumbar discectomy in patients treated with annular closure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Spondylolisthesis Grade II or higher (25% slip or greater).
Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain (scar tissue and osteophyte removal is allowed).
Subject has been diagnosed with active hepatitis, AIDS, or HIV.
Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Postoperative therapy
Other interventionInvestigating different postoperative restrictions after lumbar disc herniation surgery
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Non restricted postoperative instructionsExperimental treatment 1 intervention
Group B: Restricted postoperative instructionsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Symptomatic reherniation
No symptomatic reherniation at the index level (on either side)
Time frame
3 MonthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: