Bilateral vs Unilateral CTR

NCT01961011 | Unknown DMC

• 1 other identifier: 201206073
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Carpal tunnel release is a well accepted treatment for median nerve compression at the wrist. With a prevalence of 50 per 1000, it is the most common compressive neuropathy. With a number of anatomic as well as systemic factors playing a role in the development of carpal tunnel syndrome, it is not surprising that there is a high incidence of bilaterality with this disease. Padua et al. reported that 87% of 266 consecutive cases had signs and symptoms of carpal tunnel syndrome in their contralateral hand. In patients who have bilateral carpal tunnel syndrome that has not responded to conservative treatment, surgical release is indicated. In such cases, a decision must be made whether to offer bilateral simultaneous surgical release or to stage the two affected hands to allow time to recover from each. The purpose of this study is to determine the differences in short term disability between having bilateral vs unilateral carpal tunnel release. With better understanding of the way in which patients are impaired, better recommendations may be made on which patients to indicate for simultaneous bilateral procedures and who would benefit from staging procedures, allowing the patient to recover from one hand prior to proceeding to surgery on the other hand.

Conditions

Carpal Tunnel Syndrome

Keywords

nerve compression, carpal tunnel, clinical decision making

Outcome Measures

Primary Outcomes (1)

• Change in QuickDASH score

  The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.

  10 days, 30 days

Secondary Outcomes (1)

• World Health Organization Health and Performance Questionnaire

  30 days

Study Arms (2)

Cohort #1: Bilateral carpal tunnel release

Cohort #1: Patients undergoing simultaneous bilateral carpal tunnel release for treatment of bilateral carpal tunnel syndrome. Inclusion criteria includes any adult patient indicated for bilateral carpal tunnel release. Exclusion criteria include age less than 18, pregnancy, any protected patient population, and the lack of assistance at home during the early postoperative period.

Cohort #2: Unilateral carpal tunnel release

Cohort #2: Patients undergoing unilateral carpal tunnel release fir bilateral carpal tunnel syndrome. Patients will chose which hand they wish to have operated on. Patient will plan on undergoing carpal tunnel release on the unoperated side at a later date. Inclusion criteria include any adult patient indicated for unilateral carpal tunnel release. Exclusion criteria include age less than 18, pregnancy, and any protected patient population.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting to a tertiary care orthopedic practice with bilateral carpal tunnel syndrome

You may qualify if:

• \- any adult patient indicated for bilateral carpal tunnel release after having failed nonoperative treatment.

You may not qualify if:

• age less than 18
• pregnancy
• any protected patient population

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63130, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Neuroma; Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopedic Surgery

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 11, 2013
• Study Start: June 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: March 1, 2014
• Last Updated: October 11, 2013

Record last verified: 2013-10

Locations

US (2)