Carpal Tunnel SyndromeNCT03757416
Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by University of Tennessee.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Data collection
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients of The Plastic Surgery Group/Hayes Hand Center at Erlanger Health System
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Outcomes After Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome: A Prospective Study
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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Data collection
- Keywords
- recurrent, carpal tunnel release, flexor tenosynovectomy
- Medical subject headings
- Carpal Tunnel Syndrome, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (2)
DASH (Disabilities of the Arm, Shoulder, and Hand) score
standard, validated patient-reported questionnaire evaluating arm/shoulder/hand function and quality of life
Measured: one year
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)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study startFeb 2016
- Primary completionNov 2018
- Study completionNov 2018
Why it stopped: Low enrollment; Physician practice relocating
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D M Jemison, MD, Principal investigator, University of Tennessee College of Medicine Chattanooga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757416
- Sponsor's protocol ID
- 15-110
- Status last verified
- Nov 2018
- First submitted
- 3 May 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome: A Prospective Study
- ClinicalTrials.gov ID
- NCT03757416
- Acronym / sponsor ID
- 15-110
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- recurrent, carpal tunnel release, flexor tenosynovectomy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment; Physician practice relocating
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flexor tenosynovectomy surgery | – | Other: Data collectionAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients of The Plastic Surgery Group/Hayes Hand Center at Erlanger Health System
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionIf 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. | Other | Flexor tenosynovectomy surgery |
Primary outcome
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.
2 secondary outcomes
DASH (Disabilities of the Arm, Shoulder, and Hand) score
Time frame: one year
Patient 'satisfaction'
Time frame: one year
Results and safety
The study was stopped early (reason given: Low enrollment; Physician practice relocating). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D M Jemison, MD principal investigator
University of Tennessee College of Medicine Chattanooga
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by University of Tennessee.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment; Physician practice relocating). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Symptoms (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.