Carpal Tunnel SyndromeNCT00435071
The Effect of Surgical Incision Size on Carpal Tunnel Surgery
A study testing Carpal Tunnel Release Surgery in people with Carpal Tunnel Syndrome, run by Vanderbilt University at 1 site in United States.
Trial summary
This study will investigate the postoperative recovery advantages from having a smaller incision to a larger incision. 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?
- Carpal Tunnel Release Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jun 2008
- Phase
- Interventional
- 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
Who may be able to join
- Patients undergoing open carpal tunnel release will be included in this study.
- Patients must have clinical evidence of Carpal Tunnel Syndrome
- Patients must have positive EMG results
- Patient selection factors include:
- Ability and willingness to follow instructions
- Patients who are able and willing to return for follow-up evaluations.
- Patients of all races and genders.
- Patients who are able to follow care instructions.
Who cannot join
- Patients less than 18 years old
- Patients unwillingly or unable to comply with a rehabilitation program for carpal tunnel release who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
- Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Orthopaedic Institute
Nashville, Tennessee, 37232-8828
About this study
This study will investigate the postoperative recovery advantages from having a smaller incision to a larger incision.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Carpal Tunnel Release Surgery
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpal Tunnel Release SurgeryProcedure or surgery
Patient will have large incision size during carpal tunnel release surgery.
Carpal tunnel release surgeryProcedure or surgery
Patient will have a small incision size during carpal tunnel release surgery.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: Carpal Tunnel Release Surgery |
| 2 | Active comparator | Not described Receives: Procedure: Carpal tunnel release surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function questionnaires, pain assessment questionnaires, and clinical measurements will be used to determine the outcome of this study.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Investigator initiated suspension to focus on other studies.
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- Julie Daniels, Study director, VUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435071
- Sponsor's protocol ID
- 061043
- Status last verified
- Feb 2011
- First submitted
- 12 Feb 2007
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Surgical Incision Size on Carpal Tunnel Surgery
- ClinicalTrials.gov ID
- NCT00435071
- Acronym / sponsor ID
- 061043
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator initiated suspension to focus on other studies.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 14 Feb 2007 (estimated)
- 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.
This study will investigate the postoperative recovery advantages from having a smaller incision to a larger incision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Carpal Tunnel Release Surgery |
| 2 | Active comparator | Procedure: Carpal tunnel release surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients undergoing open carpal tunnel release will be included in this study.
- Patients must have clinical evidence of Carpal Tunnel Syndrome
- Patients must have positive EMG results
- Ability and willingness to follow instructions
- Patients who are able and willing to return for follow-up evaluations.
Key exclusion criteria (3 listed)
- Patients less than 18 years old
- Patients unwillingly or unable to comply with a rehabilitation program for carpal tunnel release who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
- Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
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 |
|---|---|---|
| Carpal Tunnel Release SurgeryPatient will have large incision size during carpal tunnel release surgery. | Procedure or surgery | 1 |
| Carpal tunnel release surgeryPatient will have a small incision size during carpal tunnel release surgery. | Procedure or surgery | 2 |
Primary outcome
Function questionnaires, pain assessment questionnaires, and clinical measurements will be used to determine the outcome of this study.
Time frame: 6 month
Results and safety
The study was stopped early (reason given: Investigator initiated suspension to focus on other studies.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
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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.
Julie Daniels study director
VUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carpal Tunnel Release Surgery in people with Carpal Tunnel Syndrome, run by Vanderbilt University at 1 site in United States.
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 8 inclusion and 3 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 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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: Investigator initiated suspension to focus on other studies.). 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?
Function questionnaires, pain assessment questionnaires, and clinical measurements will be used to determine the outcome of this study. (time frame: 6 month). 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 18 Feb 2011.