- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01887145
Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome
May 5, 2015 updated by: Region Skane
Endoscopic Versus Open Carpal Tunnel Release: 10 to 15 Years Follow-up of a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
124
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria (original trial):
- Primary idiopathic carpal tunnel syndrome
- age 25-60 years
- currently employed
- duration of symptoms of at least three months
- inadequate response to six weeks' treatment with wrist splint
- symptoms of classic or probable carpal tunnel syndrome according to the diagnostic criteria in the Katz hand diagram, and nerve conduction test showing median neuropathy at the wrist (distal motor latency ≥4.5 milliseconds, wrist-digit sensory latency ≥3.5 milliseconds, or sensory conduction velocity at the carpal tunnel segment <40 metres/second but no other abnormalities.
Exclusion Criteria (original trial):
Inflammatory joint disease
- diabetes mellitus, thyroid disorder, pregnancy, trauma to the affected hand during the preceding year
- previous carpal tunnel release surgery in the affected hand
- carpal tunnel release surgery in the contralateral hand during the preceding year
- symptoms of carpal tunnel syndrome in the contralateral hand not adequately relieved by splint at the time of enrollment
- current sick leave because of disorders other than carpal tunnel syndrome
- inability to complete questionnaires because of language problem or cognitive disorder.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Open surgery
Open surgery is Open carpal tunnel release
|
Open carpal tunnel release using conventional open technique under local anesthesia and tourniquet.
The incision in the open procedure extended from about 1 cm proximal to 3 cm distal to the wrist crease.
The transverse carpal ligament was divided; no additional procedures were performed.
a soft dressing was applied.
Dressing and sutures were removed 10 days postoperatively.
Other Names:
|
Experimental: Endoscopic surgery
Endoscopic surgery is 2-portal endoscopic carpal tunnel release
|
Surgery dwas done under local anesthesia injected at the portal sites only.
Tourniquet was used.
Each of the two skin incisions in the endoscopic procedure was 1 cm long.
With the endoscope inserted from the distal portal and a hook knife inserted from the proximal portal, the transverse carpal ligament was divided from its distal edge to its proximal edge.
Incisions were closed with non-absorbables sutures and a soft dressing was applied.
Sutures were removed 10 days postoperatively.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in CTS symptom severity score
Time Frame: Baseline to 10-15 years postoperatively
|
Baseline to 10-15 years postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of repeat surgery
Time Frame: 10-15 years postoperatively
|
10-15 years postoperatively
|
Change in CTS functional status score
Time Frame: from baseline and 1 year to 10-15 years postoperatively
|
from baseline and 1 year to 10-15 years postoperatively
|
Residual pain in the scar or proximal palm
Time Frame: 10-15 years postoperatively
|
10-15 years postoperatively
|
Patient satisfaction with the results of surgery
Time Frame: 10-15 years postoperatively
|
10-15 years postoperatively
|
Change in CTS symptom severity score
Time Frame: 1 year to 10-15 years postoperatively
|
1 year to 10-15 years postoperatively
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CTS-6 score
Time Frame: 10-15 years postoperatively
|
10-15 years postoperatively
|
QuickDASH score
Time Frame: 10-15 years postoperatively
|
10-15 years postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Isam Atroshi, MD, PhD, Clinical Sciences, Lund University, Sweden
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Atroshi I, Larsson GU, Ornstein E, Hofer M, Johnsson R, Ranstam J. Outcomes of endoscopic surgery compared with open surgery for carpal tunnel syndrome among employed patients: randomised controlled trial. BMJ. 2006 Jun 24;332(7556):1473. doi: 10.1136/bmj.38863.632789.1F. Epub 2006 Jun 15.
- Atroshi I, Hofer M, Larsson GU, Ranstam J. Extended Follow-up of a Randomized Clinical Trial of Open vs Endoscopic Release Surgery for Carpal Tunnel Syndrome. JAMA. 2015 Oct 6;314(13):1399-401. doi: 10.1001/jama.2015.12208. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
June 24, 2013
First Submitted That Met QC Criteria
June 25, 2013
First Posted (Estimate)
June 26, 2013
Study Record Updates
Last Update Posted (Estimate)
May 6, 2015
Last Update Submitted That Met QC Criteria
May 5, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HLM-CTSRCT-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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