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Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03757416
Recruitment Status : Terminated (Low enrollment; Physician practice relocating)
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Carpal Tunnel Syndrome Other: Data collection

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 Design
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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Outcomes After Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome: A Prospective Study
Study Start Date : February 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients of The Plastic Surgery Group/Hayes Hand Center at Erlanger Health System
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757416


Sponsors and Collaborators
University of Tennessee
Investigators
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Principal Investigator: D M Jemison, MD University of Tennessee College of Medicine Chattanooga
More Information
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Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT03757416    
Other Study ID Numbers: 15-110
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Tennessee:
recurrent
carpal tunnel release
flexor tenosynovectomy
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries