- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03757416
Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome
Outcomes After Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome: A Prospective Study
Study Overview
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
one year
|
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)
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: D M Jemison, MD, University of Tennessee College of Medicine Chattanooga
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carpal Tunnel Syndrome
-
Stanford UniversityMayo Clinic; Brown University; Duke University; Harvard University; University of...CompletedCarpal Tunnel Syndrome | Carpal Tunnel | Carpal Tunnel Syndrome Bilateral | Carpal Tunnel Syndrome Left | Carpal Tunnel Syndrome RightUnited States
-
Issa, Abdulhamid Sayed, M.D.CompletedCarpal Tunnel Syndrome | CTS | Carpal Tunnel Release | Carpal Tunnel Surgery | Carpal Tunnel Transverse ApproachSyrian Arab Republic
-
University of Split, School of MedicineCompletedCarpal Tunnel Syndrome BilateralCroatia
-
Ohio State UniversityCompletedBilateral Carpal Tunnel Syndrome (Diagnosis)United States
-
CMC Ambroise ParéCompletedCarpal Tunnel ReleaseFrance
-
Vanderbilt UniversityOrthopedic Research and Education FoundationCompleted
-
University of PittsburghWithdrawnPain After Carpal Tunnel ReleaseUnited States
-
Centre Hospitalier Saint Joseph Saint Luc de LyonRecruitingCarpal Tunnel Syndrome BilateralFrance
-
Istituto Ortopedico RizzoliCompletedEntrapment Neuropathy, Carpal Tunnel | Compression Neuropathy, Carpal Tunnel | Median Neuropathy, Carpal TunnelItaly
-
David TangRecruitingCarpal Tunnel Syndrome | Splints | Carpal Tunnel | Nerve Compression | Carpal Tunnel Release | Hand Injuries and DisordersCanada
Clinical Trials on Data collection
-
Care Management PlusCompletedHealth Information Technology | Nurse Based Care ManagementUnited States
-
University Hospital, Basel, SwitzerlandRecruitingInfections With CPBSwitzerland
-
M.D. Anderson Cancer CenterUnknownPediatric CancerUnited States
-
GlaxoSmithKlineCompletedInfections, StreptococcalRomania, Slovenia, Poland, Lithuania, Estonia
-
GCS Ramsay Santé pour l'Enseignement et la RechercheNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisRecruiting
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Hospices Civils de LyonCompleted
-
Women and Infants Hospital of Rhode IslandTerminated