Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome

Terminated

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: Data collection

• Registration Number: NCT03757416
• Lead Sponsor: University of Tennessee

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.

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2018-05-03
• Status Verified: 2018-11
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Study First Submitted QC: 2018-11-27
• Last Update Submitted: 2018-11-27
• Study First Posted: 2018-11-28
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Flexor tenosynovectomy surgery	Data collection	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.

Primary Outcome Measures

Name	Time	Method
Improvement of Symptoms	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

Name	Time	Method
DASH (Disabilities of the Arm, Shoulder, and Hand) score	one year	standard, validated patient-reported questionnaire evaluating arm/shoulder/hand function and quality of life
Patient 'satisfaction'	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)