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Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome

Outcomes After Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome: A Prospective Study

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03757416
Enrollment
2
Registered
2018-11-28
Start date
2016-02-29
Completion date
2018-11-30
Last updated
2018-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

recurrent, carpal tunnel release, flexor tenosynovectomy

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.

Interventions

OTHERData 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.

Sponsors

University of Tennessee
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement of Symptomsone 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

MeasureTime frameDescription
DASH (Disabilities of the Arm, Shoulder, and Hand) scoreone yearstandard, validated patient-reported questionnaire evaluating arm/shoulder/hand function and quality of life
Patient 'satisfaction'one yearDetermined through patient/provider interview at one-year follow-up visit: Is the patient 'satisfied' with the results after surgery? (Yes or No)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026