NCT01887145

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

June 24, 2013

Last Update Submit

May 5, 2015

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal tunnel syndromeSurgeryOutcomes

Outcome Measures

Primary Outcomes (1)

  • Change in CTS symptom severity score

    Baseline to 10-15 years postoperatively

Secondary Outcomes (5)

  • Rate of repeat surgery

    10-15 years postoperatively

  • Change in CTS functional status score

    from baseline and 1 year to 10-15 years postoperatively

  • Residual pain in the scar or proximal palm

    10-15 years postoperatively

  • Patient satisfaction with the results of surgery

    10-15 years postoperatively

  • Change in CTS symptom severity score

    1 year to 10-15 years postoperatively

Other Outcomes (2)

  • CTS-6 score

    10-15 years postoperatively

  • QuickDASH score

    10-15 years postoperatively

Study Arms (2)

Open surgery

ACTIVE COMPARATOR

Open surgery is Open carpal tunnel release

Procedure: Open surgery

Endoscopic surgery

EXPERIMENTAL

Endoscopic surgery is 2-portal endoscopic carpal tunnel release

Procedure: Endoscopic surgery

Interventions

Endoscopic surgeryPROCEDURE

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.

Also known as: Endoscopic carpal tunnel release surgery
Endoscopic surgery
Open surgeryPROCEDURE

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.

Also known as: Open carpal tunnel release surgery
Open surgery

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 16777857BACKGROUND

  • 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.

    PMID: 26441187DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

EndoscopyConversion to Open Surgery

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Isam Atroshi, MD, PhD

    Clinical Sciences, Lund University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2013

First Posted

June 26, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

May 6, 2015

Record last verified: 2015-05