Carpal Tunnel SyndromeNCT05325567
Comparative Study of Two Incision vs. Mini Open Carpal Tunnel Release
A study testing Mini open incision CTR in people with Carpal Tunnel Syndrome, run by University of Louisville at 1 site in United States.
Trial summary
Hand surgeons have many options to perform carpal tunnel release surgery. Some surgeons believe that techniques are best kept simple: a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease will offer good outcomes. 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?
- Mini open incision CTR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 3 Jan 2023
- 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
- Participants over the age of 18
- Patients who have not undergone any prior wrist surgery that may alter the native wrist anatomy
- Participants surgery must only be carpal tunnel release (no trigger fingers, de quervain release, etc.)
- Participants must have read and understood the consent form for the performance of the procedure and enrollment into the study. Consent must be signed in front of the principal investigator and a witness
Who cannot join
- Patients who are under the age of 18
- Patients who had other major surgery on the extremity being assessed potentially altering the native anatomy of the volar wrist area
- Patients who plan to have multiple hand procedures done along with their carpal tunnel release
- Patients refusing to sign the consent and enrollment form for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Kleinert Kutz Hand Care Center
Louisville, Kentucky, 40202
About this study
Official title: Comparative Study of Post-Operative Outcomes of the Two-Incision Carpal Tunnel Release vs Mini-Open Carpal Tunnel Release
Hand surgeons have many options to perform carpal tunnel release surgery. Some surgeons believe that techniques are best kept simple: a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease will offer good outcomes. Others feel that as a minimally invasive technique, it is integral to spare the soft tissue structures superficial to the TCL.
This study aims to determine whether sparing these superficial structures indeed improves patient outcomes, compared to a conventional two incision approach.
Read the detailed description
Carpal tunnel release (CTR) is a common surgery done by hand surgeons. The aim of the procedure is to decompress the median nerve at the level of the wrist and alleviate patient symptoms that include numbness, pain and tingling sensations along the median nerve distribution. Many versions of the technique have been described, with each description claiming improvement of post-operative results and decreasing complications.
The first description of carpal tunnel release is believed to be that of Learmonth in 1933 where he describes incising the transverse carpal ligament in a lady with a wrist fracture1. Since then, the understanding towards carpal tunnel syndrome has markedly improved, and various surgical techniques have been developed.
Because carpal tunnel syndrome has become such a common condition among the population, much knowledge has been gained about carpal tunnel surgery as well. One of the easily avoided complications of the procedure is scar related morbidity and pillar pain. Bromley offered a mini-palm open carpal tunnel release technique that decompressed the median nerve while keeping the entirety of the incision distal to the wrist crease. Tsai et al and Wilson also offered two-incision open carpal tunnel release techniques in order to keep incisions small but ensure complete release both proximally and distally. Endoscopic techniques were also eventually developed with the aim of a complete release while avoiding scar related complications.
With the many options surgeons have on how to decompress the median nerve, some begin to question if techniques are being made unnecessarily complicated. Some believe that techniques are best kept simple: a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease will offer good outcomes. Others feel that as a minimally invasive technique, it is integral to spare the soft tissue structures superficial to the TCL.
This study aims to determine whether sparing these superficial structures indeed improves patient outcomes.
Hypothesis:
Null hypothesis: There is no difference in post-operative outcomes between a mini-open carpal tunnel release and a two incision carpal tunnel release
Alternative hypothesis: A two-incision carpal tunnel release will yield improvement in post operative outcomes compared to that of the mini-open carpal tunnel release
Aim of the Study:
This study aims to determine whether sparing of the soft tissue structures superficial to the transverse carpal ligament will improve post-operative outcomes of patients undergoing carpal tunnel surgery.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Mini open incision CTR
- 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.
Mini open incision CTRProcedure or surgery
Also called Two incision CTR
two techniques commonly used for carpal tunnel release are being compared to determine if one vs. the other provides superior patient outcomes.
| Study group | Role | What they receive |
|---|---|---|
| 1 incision technique | Active comparator | a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease. Receives: Procedure: Mini open incision CTR |
| Two incision technique | Active comparator | A two-incision open carpal tunnel release techniques to ensure complete release both proximally and distally Receives: Procedure: Mini open incision CTR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of carpal tunnel symptoms
Reporting 2 or less on the 0-10 pain scale, with 0 as no pain
Measured: Six weeks
Secondary outcomes (1)
Time to return to work
How long it takes the subject to return to work
Measured: Six 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 2022
- Study start15 Jun 2022
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Why it stopped: study was not renewed.
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 University of LouisvilleThe 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
- Model description
- On the day of surgery, all enrolled patients who happen to be in the list in an odd number will undergo 1 incision technique while those on the list who are in an even number will undergo 2 incision technique.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Christine M. Kleinert Institute for Hand and Microsurgery
- Responsible party
- Sponsor
- Investigators
- Huey Tien, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325567
- Sponsor's protocol ID
- 21.0802
- Status last verified
- Aug 2023
- First submitted
- 28 Mar 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Post-Operative Outcomes of the Two-Incision Carpal Tunnel Release vs Mini-Open Carpal Tunnel Release
- ClinicalTrials.gov ID
- NCT05325567
- Acronym / sponsor ID
- 21.0802
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study was not renewed.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Christine M. Kleinert Institute for Hand and Microsurgery
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 13 Apr 2022 (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.
Hand surgeons have many options to perform carpal tunnel release surgery. Some surgeons believe that techniques are best kept simple: a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease will offer good outcomes. Others feel that as a minimally invasive technique, it is integral to spare the soft tissue structures superficial to the TCL.
This study aims to determine whether sparing these superficial structures indeed improves patient outcomes, compared to a conventional two incision approach.
Detailed description
Carpal tunnel release (CTR) is a common surgery done by hand surgeons. The aim of the procedure is to decompress the median nerve at the level of the wrist and alleviate patient symptoms that include numbness, pain and tingling sensations along the median nerve distribution. Many versions of the technique have been described, with each description claiming improvement of post-operative results and decreasing complications.
The first description of carpal tunnel release is believed to be that of Learmonth in 1933 where he describes incising the transverse carpal ligament in a lady with a wrist fracture1. Since then, the understanding towards carpal tunnel syndrome has markedly improved, and various surgical techniques have been developed.
Because carpal tunnel syndrome has become such a common condition among the population, much knowledge has been gained about carpal tunnel surgery as well. One of the easily avoided complications of the procedure is scar related morbidity and pillar pain. Bromley offered a mini-palm open carpal tunnel release technique that decompressed the median nerve while keeping the entirety of the incision distal to the wrist crease. Tsai et al and Wilson also offered two-incision open carpal tunnel release techniques in order to keep incisions small but ensure complete release both proximally and distally. Endoscopic techniques were also eventually developed with the aim of a complete release while avoiding scar related complications.
With the many options surgeons have on how to decompress the median nerve, some begin to question if techniques are being made unnecessarily complicated. Some believe that techniques are best kept simple: a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease will offer good outcomes. Others feel that as a minimally invasive technique, it is integral to spare the soft tissue structures superficial to the TCL.
This study aims to determine whether sparing these superficial structures indeed improves patient outcomes.
Hypothesis:
Null hypothesis: There is no difference in post-operative outcomes between a mini-open carpal tunnel release and a two incision carpal tunnel release
Alternative hypothesis: A two-incision carpal tunnel release will yield improvement in post operative outcomes compared to that of the mini-open carpal tunnel release
Aim of the Study:
This study aims to determine whether sparing of the soft tissue structures superficial to the transverse carpal ligament will improve post-operative outcomes of patients undergoing carpal tunnel surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- On the day of surgery, all enrolled patients who happen to be in the list in an odd number will undergo 1 incision technique while those on the list who are in an even number will undergo 2 incision technique.
| Arm | Type | Receives |
|---|---|---|
| 1 incision technique | Active comparator | Procedure: Mini open incision CTRa mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease. |
| Two incision technique | Active comparator | Procedure: Mini open incision CTRA two-incision open carpal tunnel release techniques to ensure complete release both proximally and distally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants over the age of 18
- Patients who have not undergone any prior wrist surgery that may alter the native wrist anatomy
- Participants surgery must only be carpal tunnel release (no trigger fingers, de quervain release, etc.)
- Participants must have read and understood the consent form for the performance of the procedure and enrollment into the study. Consent must be signed in front of the principal investigator and a witness
Key exclusion criteria (4 listed)
- Patients who are under the age of 18
- Patients who had other major surgery on the extremity being assessed potentially altering the native anatomy of the volar wrist area
- Patients who plan to have multiple hand procedures done along with their carpal tunnel release
- Patients refusing to sign the consent and enrollment form for 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 |
|---|---|---|
| Mini open incision CTRAlso: Two incision CTRtwo techniques commonly used for carpal tunnel release are being compared to determine if one vs. the other provides superior patient outcomes. | Procedure or surgery | 1 incision technique, Two incision technique |
Primary outcome
Resolution of carpal tunnel symptoms
Time frame: Six weeks
Reporting 2 or less on the 0-10 pain scale, with 0 as no pain
1 secondary outcome
Time to return to work
Time frame: Six weeks
Results and safety
The study was stopped early (reason given: study was not renewed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Huey Tien, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini open incision CTR in people with Carpal Tunnel Syndrome, run by University of Louisville 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 4 inclusion and 4 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 Aug 2023. 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: study was not renewed.). 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?
Resolution of carpal tunnel symptoms (time frame: Six 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 18 Aug 2023.