Carpal Tunnel SyndromeCTRMTANCT02766114
Carpal Tunnel Release Through Mini Transverse Approach
A study testing Carpal tunnel release through Mini Transverse Approach in people with Carpal Tunnel Syndrome and Carpal Tunnel Release, run by Issa, Abdulhamid Sayed, M.D. at 1 site in Syria.
Trial summary
Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm length. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Carpal Tunnel Release, Carpal Tunnel Surgery
- What is being tested?
- Carpal tunnel release through Mini Transverse Approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSyria
- Study dates
- Feb 2013to Mar 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients presented with Carpal Tunnel Syndrome refractory to conservative treatment
- Participant cooperation sufficient to operate under local anesthesia
Who cannot join
- Un controlled diabetes mellitus type 1 and 2
- Patients with non controlled Vascular hypertension
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- Patients with history of Carpal Tunnel release surgery failure
Trial locations and contacts
1 site in 1 country.
About this study
Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm length.
Read the detailed description
Carpal tunnel release through a small approach on the distal wrist crease, it is about 1.5 cm, the benefits of this technique is less surgical traumatic and more tender, it takes less time for rehabilitation, so the patient can work next day of operation, and it has very cosmetic and gentle scar in results and outcome.
- Conditions
- Carpal Tunnel Syndrome, Carpal Tunnel Release, Carpal Tunnel Surgery, Carpal Tunnel Transverse Approach, CTS
- Being tested
- Carpal tunnel release through Mini Transverse Approach
- Keywords
- CTS, Carpal tunnel syndrome, Carpal tunnel release, Mini incision of carpal tunnel release, Cosmetic surgery of carpal tunnel syndrome, endoscopic carpal tunnel surgery, Carpal Tunnel Release Through Mini Transverse Approach, Dr. Sayed Issa's Approach, CTRMTA, OCTR, ECTR, Open Carpal Tunnel Release, Endoscopic Carpal Tunnel Release, Syria, Cosmetic, Safety, Rehabilitation,, Complications, Surgery, Satisfaction
- Medical subject headings
- Carpal Tunnel Syndrome, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpal tunnel release through Mini Transverse ApproachProcedure or surgery
Carpal tunnel release through a transverse cosmetic small incision over the distal wrist crease.
| Study group | Role | What they receive |
|---|---|---|
| Issa1 | Experimental | After local anesthesia, through transverse approach on the middle of dorsal wrist crease the incision is made for 1.5 cm length, then the subcutaneous fat is dissected, soon we see the the palmaris longus tendon or its connection with the carpal ligament , take the ulnar side of the palmaris longus tendon and cut the carpal ligament axillary by scalpel, not going deep with the scalpel to avoid medial nerve injury, soon we see the nerve, we use the scissors to cut the proximal part then the distal part of the carpal ligament by enclosing it between the blades of the scissors, now the full released carpal tunnel most be observed, and one stitch is enough, in this operation most be an assistant exist. Receives: Procedure: Carpal tunnel release through Mini Transverse Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with post surgical trauma
Measured: Up to eight weeks
Secondary outcomes (2)
Duration of rehabilitation period
Measured: Up to three weeks
Proportion of patients with cosmetic scar
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startFeb 2013
- Primary completionMar 2016
- Study completionMar 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Issa, Abdulhamid Sayed, M.D.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766114
- Sponsor's protocol ID
- Sayed Issa's Approach
- Acronym
- CTRMTA
- Status last verified
- May 2016
- First submitted
- 4 May 2016
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpal Tunnel Release Through Mini Transverse Approach
- ClinicalTrials.gov ID
- NCT02766114
- Acronym / sponsor ID
- CTRMTA / Sayed Issa's Approach
- Conditions
- Carpal Tunnel Syndrome, Carpal Tunnel Release, Carpal Tunnel Surgery, Carpal Tunnel Transverse Approach, CTS
- Keywords
- CTS, Carpal tunnel syndrome, Carpal tunnel release, Mini incision of carpal tunnel release, Cosmetic surgery of carpal tunnel syndrome, endoscopic carpal tunnel surgery, Carpal Tunnel Release Through Mini Transverse Approach, Dr. Sayed Issa's Approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Issa, Abdulhamid Sayed, M.D.
- Study start
- Feb 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 May 2016 (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.
Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm length.
Detailed description
Carpal tunnel release through a small approach on the distal wrist crease, it is about 1.5 cm, the benefits of this technique is less surgical traumatic and more tender, it takes less time for rehabilitation, so the patient can work next day of operation, and it has very cosmetic and gentle scar in results and outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Issa1 | Experimental | Procedure: Carpal tunnel release through Mini Transverse ApproachAfter local anesthesia, through transverse approach on the middle of dorsal wrist crease the incision is made for 1.5 cm length, then the subcutaneous fat is dissected, soon we see the the palmaris longus tendon or its connection with the carpal ligament , take the ulnar side of the palmaris longus tendon and cut the carpal ligament axillary by scalpel, not going deep with the scalpel to avoid medial nerve injury, soon we see the nerve, we use the scissors to cut the proximal part then the distal part of the carpal ligament by enclosing it between the blades of the scissors, now the full released carpal tunnel most be observed, and one stitch is enough, in this operation most be an assistant exist. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presented with Carpal Tunnel Syndrome refractory to conservative treatment
- Participant cooperation sufficient to operate under local anesthesia
Key exclusion criteria (5 listed)
- Un controlled diabetes mellitus type 1 and 2
- Patients with non controlled Vascular hypertension
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- Patients with history of Carpal Tunnel release surgery failure
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 through Mini Transverse ApproachCarpal tunnel release through a transverse cosmetic small incision over the distal wrist crease. | Procedure or surgery | Issa1 |
Primary outcome
Proportion of patients with post surgical trauma
Time frame: Up to eight weeks
2 secondary outcomes
Duration of rehabilitation period
Time frame: Up to three weeks
Proportion of patients with cosmetic scar
Time frame: Up to 6 months
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 9 May 2016.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 through Mini Transverse Approach in people with Carpal Tunnel Syndrome and Carpal Tunnel Release, run by Issa, Abdulhamid Sayed, M.D. at 1 site in Syria.
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 5 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 9 May 2016. 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 Syria. 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?
Proportion of patients with post surgical trauma (time frame: Up to eight 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 9 May 2016.