Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome
- Conditions
- Carpal Tunnel Syndrome
- Interventions
- Procedure: Open surgeryProcedure: Endoscopic surgery
- Registration Number
- NCT01887145
- Lead Sponsor
- Region Skane
- Brief Summary
No randomized trials have compared long-term outcomes following endoscopic and open carpal tunnel release in patients with carpal tunnel syndrome (CTS). The investigators conducted a single-center randomized controlled trial between January 1998 and December 2002, including 128 patients (25 to 60 years) with clinically diagnosed and electrophysiologically confirmed idiopathic CTS. The outcome measures included the validated CTS symptom severity and functional status scales completed at baseline and 1 year postoperatively. The trial showed that the 1-year outcomes of open and endoscopic carpal tunnel release regarding symptoms and function were equivalent. This extended follow-up of the randomized trial will primarily measure the symptom outcomes at 10-15 years after surgery. A questionnaire will be sent by mail to the patients. The questionnaire will consist of the CTS symptom severity and functional status scales, the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of the arm, shoulder and hand (QuickDASH), the 2-item palmar pain scale, and a visual analog scale about treatment satisfaction. The patients will also be asked about whether they had undergone further surgery for CTS in the same or contralateral hand after their operation in the randomized trial. The completed questionnaires will be scanned into a database. The scores for the different scales will be calculated. Analysis will include comparison between the open and endoscopic groups as well as within-group changes of scores from 1 year to 10-15 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Open surgery Open surgery Open surgery is Open carpal tunnel release Endoscopic surgery Endoscopic surgery Endoscopic surgery is 2-portal endoscopic carpal tunnel release
- Primary Outcome Measures
Name Time Method Change in CTS symptom severity score Baseline to 10-15 years postoperatively
- Secondary Outcome Measures
Name Time Method Patient satisfaction with the results of surgery 10-15 years postoperatively Change in CTS symptom severity score 1 year to 10-15 years postoperatively Rate of repeat surgery 10-15 years postoperatively Change in CTS functional status score from baseline and 1 year to 10-15 years postoperatively Residual pain in the scar or proximal palm 10-15 years postoperatively