Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03757416
• Other study ID #: 15-110
• Status: Terminated
• Start date: February 2016
• Est. completion date: November 2018

Study information

• Verified date: November 2018
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	DASH (Disabilities of the Arm, Shoulder, and Hand) score	standard, validated patient-reported questionnaire evaluating arm/shoulder/hand function and quality of life	one year
Secondary	Patient 'satisfaction'	Determined through patient/provider interview at one-year follow-up visit: Is the patient 'satisfied' with the results after surgery? (Yes or No)	one year