Carpal Tunnel SyndromeNCT00880295
Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release
A study testing endoscopic carpal tunnel release and open carpal tunnel release in people with Carpal Tunnel Syndrome, run by Penn State University at 1 site in United States.
Trial summary
Although some surgeons prefer one technique rather than the other, both endoscopic and open carpal tunnel release procedures are accepted as standard of care surgeries to relieve carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- endoscopic carpal tunnel release and open carpal tunnel release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2009to 26 Jul 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18 and 75
- Documented clinical and electromyography (EMG) proven carpal tunnel syndrome
Who cannot join
- Recurrent carpal tunnel syndrome
- Inflammatory arthropathy
- Peripheral neuropathy
- Diabetes
- < 18 or > 75 years old
- Pregnant at the time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Endoscopic vs Open Carpal Tunnel Release: Comparison of Patient Satisfaction, Outcomes, and Complications
Although some surgeons prefer one technique rather than the other, both endoscopic and open carpal tunnel release procedures are accepted as standard of care surgeries to relieve carpal tunnel syndrome. The investigator's research is designed to evaluate the significant difference in patient satisfaction between endoscopically-released wrists and open-released wrists. The goal of the study is to compare the two techniques using the following criteria:
- Primary outcome: patient satisfaction via surveys used in prior publications
- Secondary outcome: length of time to return to work
- Secondary outcome: clinical data for recovery from carpal tunnel syndrome including a thorough physical exam and EMG's
- Secondary outcome: complication rates
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- endoscopic carpal tunnel release, open carpal tunnel release
- 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.
endoscopic carpal tunnel releaseProcedure or surgery
endoscopic surgery, which is standard of care for carpal tunnel release
open carpal tunnel releaseProcedure or surgery
open surgery, which is standard of care for carpal tunnel release
| Study group | Role | What they receive |
|---|---|---|
| endoscopic surgery | Active comparator | Not described Receives: Procedure: endoscopic carpal tunnel release |
| open surgery | Active comparator | Not described Receives: Procedure: open carpal tunnel release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: patient satisfaction via surveys used in prior publications
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study start23 Mar 2009
- Primary completion26 Jul 2016
- Study completion26 Jul 2016
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.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Nogan, B.S., Principal investigator, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880295
- Sponsor's protocol ID
- 24457
- Status last verified
- Nov 2017
- First submitted
- 10 Apr 2009
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic vs Open Carpal Tunnel Release: Comparison of Patient Satisfaction, Outcomes, and Complications
- ClinicalTrials.gov ID
- NCT00880295
- Acronym / sponsor ID
- 24457
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 23 Mar 2009 (actual)
- Primary completion
- 26 Jul 2016 (actual)
- Study completion
- 26 Jul 2016 (actual)
- First posted
- 13 Apr 2009 (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.
Although some surgeons prefer one technique rather than the other, both endoscopic and open carpal tunnel release procedures are accepted as standard of care surgeries to relieve carpal tunnel syndrome. The investigator's research is designed to evaluate the significant difference in patient satisfaction between endoscopically-released wrists and open-released wrists. The goal of the study is to compare the two techniques using the following criteria:
- Primary outcome: patient satisfaction via surveys used in prior publications
- Secondary outcome: length of time to return to work
- Secondary outcome: clinical data for recovery from carpal tunnel syndrome including a thorough physical exam and EMG's
- Secondary outcome: complication rates
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopic surgery | Active comparator | Procedure: endoscopic carpal tunnel release |
| open surgery | Active comparator | Procedure: open carpal tunnel release |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between the ages of 18 and 75
- Documented clinical and electromyography (EMG) proven carpal tunnel syndrome
Key exclusion criteria (6 listed)
- Recurrent carpal tunnel syndrome
- Inflammatory arthropathy
- Peripheral neuropathy
- Diabetes
- < 18 or > 75 years old
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 |
|---|---|---|
| endoscopic carpal tunnel releaseendoscopic surgery, which is standard of care for carpal tunnel release | Procedure or surgery | endoscopic surgery |
| open carpal tunnel releaseopen surgery, which is standard of care for carpal tunnel release | Procedure or surgery | open surgery |
Primary outcome
Primary outcome: patient satisfaction via surveys used in prior publications
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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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.
Stephen Nogan, B.S. principal investigator
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic carpal tunnel release and open carpal tunnel release in people with Carpal Tunnel Syndrome, run by Penn State 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 2 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: finished, as of the sponsor's last update on 24 Nov 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary outcome: patient satisfaction via surveys used in prior publications (time frame: 24 weeks). 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 24 Nov 2017.