Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome

NCT03757416 | Terminated

• 1 other identifier: 15-110
• Study Type: observational
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carpal Tunnel Syndrome

Keywords

recurrent; carpal tunnel release; flexor tenosynovectomy

Outcome Measures

Primary Outcomes (1)

• Improvement of Symptoms

  '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 Outcomes (2)

• DASH (Disabilities of the Arm, Shoulder, and Hand) score

  one year

• Patient 'satisfaction'

  one year

Study Arms (1)

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

Interventions

Data collection 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.

Flexor tenosynovectomy surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Recurrence

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• D M Jemison, MD

  University of Tennessee College of Medicine Chattanooga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: November 28, 2018
• Study Start: February 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share