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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01887145
First received: June 24, 2013
Last updated: June 25, 2013
Last verified: May 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of repeat surgery [ Time Frame: 10-15 years postoperatively ] [ Designated as safety issue: Yes ]
  • Change in CTS functional status score [ Time Frame: from baseline and 1 year to 10-15 years postoperatively ] [ Designated as safety issue: Yes ]
  • Residual pain in the scar or proximal palm [ Time Frame: 10-15 years postoperatively ] [ Designated as safety issue: Yes ]
  • Patient satisfaction with the results of surgery [ Time Frame: 10-15 years postoperatively ] [ Designated as safety issue: No ]
  • Change in CTS symptom severity score [ Time Frame: 1 year to 10-15 years postoperatively ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • CTS-6 score [ Time Frame: 10-15 years postoperatively ] [ Designated as safety issue: Yes ]
  • QuickDASH score [ Time Frame: 10-15 years postoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 126
Study Start Date: September 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (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

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01887145

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

Publications:
Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01887145     History of Changes
Other Study ID Numbers: HLM-CTSRCT-2
Study First Received: June 24, 2013
Last Updated: June 25, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Carpal tunnel syndrome
Surgery
Outcomes

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

ClinicalTrials.gov processed this record on October 30, 2014