search
Back to results

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
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal tunnel syndrome, Surgery, Outcomes

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 24, 2013
    Last Updated
    May 5, 2015
    Sponsor
    Region Skane
    search

    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

    Learn more about this trial

    Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome

    We'll reach out to this number within 24 hrs