Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome

NCT ID: NCT03757416

Last Updated: 2018-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Data collection

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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D M Jemison, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee College of Medicine Chattanooga

Other Identifiers

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15-110

Identifier Type: -

Identifier Source: org_study_id

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