Carpal Tunnel Syndrome (CTS)NCT07509437
Simultaneous vs. Postponed Carpal Tunnel Release (CTR) During Distal Radius Fracture (DRF) Fixation.
A study testing Carpal tunnel release and Distal Radius Fracture Fixation with Observation. in people with Carpal Tunnel Syndrome (CTS), run by Benha University at 1 site in Egypt.
Trial summary
This randomized study evaluates the impact of performing a prophylactic carpal tunnel release (CTR) at the same time as surgical fixation for a distal radius fracture (DRF). The study compares this simultaneous approach against a postponed approach (observing and only performing CTR if symptoms develop) to determine… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Carpal tunnel release and Distal Radius Fracture Fixation with Observation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2023to 15 Feb 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients presenting with trauma to the lower end of the radius requiring surgical intervention.
- Fractures classified as AO/OTA classes involving significant displacement, articular surface depression, or comminution (excluding simple A-C1 classes).
Who cannot join
- Simple fractures (AO/OTA class A-C1) suitable for non-operative management.
- Pre-existing neurocognitive or psychological disorders.
- Refusal to participate or sign written consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cons and Pros of Concomitant Carpal Tunnel Release During Distal Radius Fracture Fixation
This randomized study evaluates the impact of performing a prophylactic carpal tunnel release (CTR) at the same time as surgical fixation for a distal radius fracture (DRF). The study compares this simultaneous approach against a postponed approach (observing and only performing CTR if symptoms develop) to determine which strategy better reduces the frequency of re-operation and improves functional outcomes.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Carpal tunnel release, Distal Radius Fracture Fixation with Observation.
- 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 releaseProcedure or surgery
During the internal fixation of the fracture via the Henry approach, the incision is extended distally into the palm. The transverse carpal ligament is incised to decompress the median nerve at the same time the bone is fixed.
Distal Radius Fracture Fixation with Observation.Procedure or surgery
Standard operative procedure for the fracture fixation only. Patients are monitored during follow-up; those who subsequently develop median nerve compression symptoms are then prepared for an elective CTR in a separate surgical setting.
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous CTR | Active comparator | Not described Receives: Procedure: Carpal tunnel release; Procedure: Distal Radius Fracture Fixation with Observation. |
| Postponed CTR) | Active comparator | Not described Receives: Procedure: Distal Radius Fracture Fixation with Observation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Symptomatic Carpal Tunnel Syndrome
The number of patients who develop symptomatic median nerve compression requiring medical or surgical intervention after the initial fracture correction.
Measured: From surgery through the completion of fracture healing (4-6 wks)
Secondary outcomes (1)
Postoperative Functional Status of the Upper Extremity.
This tool uses 11 items to measure the degree of difficulty a patient has performing specific physical activities (6 items) and the impact of symptoms like pain and numbness on social activities, work, and sleep (5 items).
- Each item is scored on a 5-point Likert scale.
- The total score is transformed into a percentage (0-100%), where a higher percentage indicates more severe disability and greater difficulty in daily functioning.
Measured: 5-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start25 Feb 2023
- Primary completion21 Aug 2025
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies 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
- Model description
- Participants are assigned to one of two distinct groups (arms) simultaneously. Each group follows a specific protocol throughout the study duration to allow for a direct head-to-head comparison of outcomes.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Samy ElHammady, Benha University
- Investigators
- Mohammed Shibl Zaki, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509437
- Sponsor's protocol ID
- RC:4.12.2022
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cons and Pros of Concomitant Carpal Tunnel Release During Distal Radius Fracture Fixation
- ClinicalTrials.gov ID
- NCT07509437
- Acronym / sponsor ID
- RC:4.12.2022
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 3 Apr 2026 (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.
This randomized study evaluates the impact of performing a prophylactic carpal tunnel release (CTR) at the same time as surgical fixation for a distal radius fracture (DRF). The study compares this simultaneous approach against a postponed approach (observing and only performing CTR if symptoms develop) to determine which strategy better reduces the frequency of re-operation and improves functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two distinct groups (arms) simultaneously. Each group follows a specific protocol throughout the study duration to allow for a direct head-to-head comparison of outcomes.
| Arm | Type | Receives |
|---|---|---|
| Simultaneous CTR | Active comparator | Procedure: Carpal tunnel release, Procedure: Distal Radius Fracture Fixation with Observation. |
| Postponed CTR) | Active comparator | Procedure: Distal Radius Fracture Fixation with Observation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting with trauma to the lower end of the radius requiring surgical intervention.
- Fractures classified as AO/OTA classes involving significant displacement, articular surface depression, or comminution (excluding simple A-C1 classes).
Key exclusion criteria (3 listed)
- Simple fractures (AO/OTA class A-C1) suitable for non-operative management.
- Pre-existing neurocognitive or psychological disorders.
- Refusal to participate or sign written consent.
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 releaseDuring the internal fixation of the fracture via the Henry approach, the incision is extended distally into the palm. The transverse carpal ligament is incised to decompress the median nerve at the same time the bone is fixed. | Procedure or surgery | Simultaneous CTR |
| Distal Radius Fracture Fixation with Observation.Standard operative procedure for the fracture fixation only. Patients are monitored during follow-up; those who subsequently develop median nerve compression symptoms are then prepared for an elective CTR in a separate surgical setting. | Procedure or surgery | Postponed CTR), Simultaneous CTR |
Primary outcome
Frequency of Symptomatic Carpal Tunnel Syndrome
Time frame: From surgery through the completion of fracture healing (4-6 wks)
The number of patients who develop symptomatic median nerve compression requiring medical or surgical intervention after the initial fracture correction.
1 secondary outcome
Postoperative Functional Status of the Upper Extremity.
Time frame: 5-10 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 3 Apr 2026.
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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.
Mohammed Shibl Zaki, MD principal investigator
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 and Distal Radius Fracture Fixation with Observation. in people with Carpal Tunnel Syndrome (CTS), run by Benha University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 3 Apr 2026. 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 Egypt. 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?
Frequency of Symptomatic Carpal Tunnel Syndrome (time frame: From surgery through the completion of fracture healing (4-6 wks)). 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 3 Apr 2026.