Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopic surgery
Open surgery
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal tunnel syndrome, Surgery, Outcomes
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Open surgery
Endoscopic surgery
Arm Description
Open surgery is Open carpal tunnel release
Endoscopic surgery is 2-portal endoscopic carpal tunnel release
Outcomes
Primary Outcome Measures
Change in CTS symptom severity score
Secondary Outcome Measures
Rate of repeat surgery
Change in CTS functional status score
Residual pain in the scar or proximal palm
Patient satisfaction with the results of surgery
Change in CTS symptom severity score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01887145
Brief Title
Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome
Official Title
Endoscopic Versus Open Carpal Tunnel Release: 10 to 15 Years Follow-up of a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal tunnel syndrome, Surgery, Outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open surgery
Arm Type
Active Comparator
Arm Description
Open surgery is Open carpal tunnel release
Arm Title
Endoscopic surgery
Arm Type
Experimental
Arm Description
Endoscopic surgery is 2-portal endoscopic carpal tunnel release
Intervention Type
Procedure
Intervention Name(s)
Endoscopic surgery
Other Intervention Name(s)
Endoscopic carpal tunnel release surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Open surgery
Other Intervention Name(s)
Open carpal tunnel release surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in CTS symptom severity score
Time Frame
Baseline to 10-15 years postoperatively
Secondary Outcome Measure Information:
Title
Rate of repeat surgery
Time Frame
10-15 years postoperatively
Title
Change in CTS functional status score
Time Frame
from baseline and 1 year to 10-15 years postoperatively
Title
Residual pain in the scar or proximal palm
Time Frame
10-15 years postoperatively
Title
Patient satisfaction with the results of surgery
Time Frame
10-15 years postoperatively
Title
Change in CTS symptom severity score
Time Frame
1 year to 10-15 years postoperatively
Other Pre-specified Outcome Measures:
Title
CTS-6 score
Time Frame
10-15 years postoperatively
Title
QuickDASH score
Time Frame
10-15 years postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isam Atroshi, MD, PhD
Organizational Affiliation
Clinical Sciences, Lund University, Sweden
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
16777857
Citation
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.
Results Reference
background
PubMed Identifier
26441187
Citation
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.
Results Reference
derived
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Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome
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