Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome

November 27, 2018 updated by: University of Tennessee

Outcomes After Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome: A Prospective Study

The purpose of this study is to collect data on the clinical and functional outcomes of surgical management for recurrent carpal tunnel syndrome (CTS) using flexor tenosynovectomy. It is hypothesized that the outcomes of patients undergoing flexor tenosynovectomy for recurrent CTS will compare favorably to published data regarding alternative types of surgeries for the same condition.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Primary carpal tunnel release (CTR) is the most common surgical procedure of the hand, but reported rates of symptom recurrence are not uncommon. Many surgical techniques have been proposed and reported for management of carpal tunnel syndrome (CTS) symptom recurrence, however there is a paucity of data on flexor tenosynovectomy for management of recurrent CTS.

This study will evaluate clinical and functional outcomes using information from pre- and post-operative physical exams, surgery data, patient-reported satisfaction and symptoms, and scores on functional measures, such as the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.

Study Type

Observational

Enrollment (Actual)

2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients of The Plastic Surgery Group/Hayes Hand Center at Erlanger Health System

Description

Inclusion Criteria:

  • Adult patients (> 18 years)
  • Patient of The Plastic Surgery Group/Hayes Hand Center
  • Previous diagnosis of Carpal Tunnel Syndrome
  • Diagnosis of Recurrent Carpal Tunnel Syndrome
  • Underwent primary carpal tunnel release
  • Undergoing isolated flexor tenosynovectomy as secondary procedure

Exclusion Criteria:

  • Had incomplete primary release of transverse carpal ligament
  • Had documented neuroma upon re-exploration
  • Had other soft tissue tumor within carpal tunnel or providing reasonable contribution to neurologic symptoms
  • Experienced fracture or other traumatic injury to wrist after primary carpal tunnel release
  • Diagnosis of osteomyelitis, infectious tenosynovitis or other infectious etiology to area of interest after primary procedure
  • Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory arthropathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Flexor tenosynovectomy surgery
Adult patients who will be undergoing flexor tenosynovectomy for the treatment of recurrent carpal tunnel syndrome and who have already undergone primary carpal tunnel release surgery.
Other: Data collection
If it has been determined that the patient will be undergoing flexor tenosynovectomy for the treatment of recurrent carpal tunnel syndrome, the patient will be asked to participate in this data collection study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of Symptoms
Time Frame: one year
'Improvement of symptoms' versus 'No change/worsening of symptoms' of carpal tunnel syndrome following flexor tenosynovectomy. Improvement vs worsening of symptoms determined by subjective physician assessment at one-year follow-up as documented through office dictation in the medical record.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH (Disabilities of the Arm, Shoulder, and Hand) score
Time Frame: one year
standard, validated patient-reported questionnaire evaluating arm/shoulder/hand function and quality of life
one year
Patient 'satisfaction'
Time Frame: one year
Determined through patient/provider interview at one-year follow-up visit: Is the patient 'satisfied' with the results after surgery? (Yes or No)
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Investigators

  • Principal Investigator: D M Jemison, MD, University of Tennessee College of Medicine Chattanooga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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