Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome

Overview

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.

Full Title of Study: “Outcomes After Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome: A Prospective Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2018

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Tennessee
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • D M Jemison, MD, Principal Investigator, University of Tennessee College of Medicine Chattanooga

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