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TerminatedNCT00435071Updated Feb 18, 2011

The Effect of Surgical Incision Size on Carpal Tunnel Surgery

An interventional study of Carpal Tunnel Release Surgery and Carpal tunnel release surgery in Carpal Tunnel Syndrome, sponsored by Vanderbilt University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-18.

Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment

Why this study was terminated
Investigator initiated suspension to focus on other studies.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will investigate the postoperative recovery advantages from having a smaller incision to a larger incision.

02

Conditions studied

  • Carpal Tunnel Syndrome
03

In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients undergoing open carpal tunnel release will be included in this study.
  • Patients must have clinical evidence of Carpal Tunnel Syndrome
  • Patients must have positive EMG results

Patient selection factors include:

  1. Ability and willingness to follow instructions
  2. Patients who are able and willing to return for follow-up evaluations.
  3. Patients of all races and genders.
  4. Patients who are able to follow care instructions.

Exclusion criteria

Exclusion Criteria:

  • Patients less than 18 years old
  • Patients unwillingly or unable to comply with a rehabilitation program for carpal tunnel release who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
  • Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    1

    Procedure: Carpal Tunnel Release Surgery

  • Active comparator
    2

    Procedure: Carpal tunnel release surgery

Interventions

  • ProcedureCarpal Tunnel Release Surgery

    Patient will have large incision size during carpal tunnel release surgery.

  • ProcedureCarpal tunnel release surgery

    Patient will have a small incision size during carpal tunnel release surgery.

06

What researchers measure

Primary outcomes

  1. Function questionnaires, pain assessment questionnaires, and clinical measurements will be used to determine the outcome of this study.

    Time frame: 6 month

07

Study locations

1 site
  • Vanderbilt Orthopaedic Institute
    Nashville, Tennessee 37232-8828, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00435071
Lead sponsor
Vanderbilt University
First posted
Feb 14, 2007
Start date
Dec 2006
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Feb 18, 2011

Study contacts

Julie Daniels
study director · VUMC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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