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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01887145
First Posted: June 26, 2013
Last Update Posted: May 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Region Skane
  Purpose
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.

Condition Intervention
Carpal Tunnel Syndrome Procedure: Endoscopic surgery Procedure: Open surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Versus Open Carpal Tunnel Release: 10 to 15 Years Follow-up of a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Change in CTS symptom severity score [ Time Frame: Baseline to 10-15 years postoperatively ]

Secondary Outcome Measures:
  • Rate of repeat surgery [ Time Frame: 10-15 years postoperatively ]
  • Change in CTS functional status score [ Time Frame: from baseline and 1 year to 10-15 years postoperatively ]
  • Residual pain in the scar or proximal palm [ Time Frame: 10-15 years postoperatively ]
  • Patient satisfaction with the results of surgery [ Time Frame: 10-15 years postoperatively ]
  • Change in CTS symptom severity score [ Time Frame: 1 year to 10-15 years postoperatively ]

Other Outcome Measures:
  • CTS-6 score [ Time Frame: 10-15 years postoperatively ]
  • QuickDASH score [ Time Frame: 10-15 years postoperatively ]

Enrollment: 124
Study Start Date: September 2013
Study Completion Date: January 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Open surgery
Open surgery is Open carpal tunnel release
Procedure: Open surgery
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 Name: Open carpal tunnel release surgery
Experimental: Endoscopic surgery
Endoscopic surgery is 2-portal endoscopic carpal tunnel release
Procedure: Endoscopic surgery
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 Name: Endoscopic carpal tunnel release surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887145


Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Isam Atroshi, MD, PhD Clinical Sciences, Lund University, Sweden
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01887145     History of Changes
Other Study ID Numbers: HLM-CTSRCT-2
First Submitted: June 24, 2013
First Posted: June 26, 2013
Last Update Posted: May 6, 2015
Last Verified: May 2015

Keywords provided by Region Skane:
Carpal tunnel syndrome
Surgery
Outcomes

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Nerve Compression Syndromes
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries