Failed Carpal Tunnel Syndrome SurgeryNCT06324617
Treatment of Failed Carpal Tunnel Syndrome by Dorsal Ulnar Artery Perforator Adipofascial Flap
A study testing Treatment of failed carpal tunnel syndrome by dorsal ulnar artery perforator adipofascial flap in people with Failed Carpal Tunnel Syndrome Surgery, run by Sohag University at 1 site in Egypt.
Trial summary
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the general population. Surgical treatment by open or endoscopic carpal tunnel release (CTR) is the first choice of treatment and has clinical success rates of 75% to 90%.The rate of recurrence after primary median nerve release is 3-19% [1,2]. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Failed Carpal Tunnel Syndrome Surgery
- What is being tested?
- Treatment of failed carpal tunnel syndrome by dorsal ulnar artery perforator adipofascial flap
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 30 Dec 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Positive tinel sign
- Operative interval more than 3 months \& less than 2 years
Who cannot join
- Cervical disc
- Associated general disease (Rheumatoid arthritis, DM ,psychological problems \& peripheral neuropathy)
Trial locations and contacts
1 site in 1 country.
Hassan H Noman, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the general population. Surgical treatment by open or endoscopic carpal tunnel release (CTR) is the first choice of treatment and has clinical success rates of 75% to 90%.The rate of recurrence after primary median nerve release is 3-19% [1,2]. Between 0.3% and 12% of cases require surgical revision [2,3]. The risk factors for surgical revision for secondary release are male gender, staged or simultaneous bilateral carpal tunnel release, endoscopic release, smoking and rheumatoid arthritis.
Treatment failures after primary CTR are classified as persistent CTS, recurrent CTS, or new symptoms. Recurrent symptoms are uncommon and are defined by a symptom-free interval after surgery. Persistent symptoms are relatively common, particularly in elderly patients and in patients with concurrent nerve compression or medical conditions that affect nerve function, such as diabetes. Persistent or recurrent CTS principally results from incomplete release of the transverse carpal ligament but may be accompanied by perineural scarring, leading to compression or tethering of the median nerve.
Read more
New symptoms may be caused by iatrogenic nerve injury. Surgical treatment of recurrent or persistent CTS after primary CTR usually involves open revision CTR, extended proximally into unscarred tissue, and has also included internal or external neurolysis. Unsatisfactory results following revision CTR are common.
A second compression site, or double-crush syndrome, may clinically present as RCTS or PCTS . Thorough preoperative clinical examination may uncover signs of a second compression site, which can then be confirmed on electroneuromyography (ENMG) of the entire arm.
To improve outcomes of revision CTR, recent studies have emphasized the importance of median nerve coverage by well-vascularized soft tissue to enhance nerve healing, to prevent tethering in surrounding scar tissue, and to optimize nerve gliding in the carpal tunnel. Several local flaps (hypothenar fat pad flap, tenosynovial flap), regional flaps (posterior interosseous artery flap, reverse radial artery fascial flap, flexor digitorum superficialis flap), and free flap techniques have been described, but consensus for specific flap has not been reached. Following potential iatrogenic median nerve injury and reexploration for a painful neuroma incontinuity, flap coverage may also be beneficial.
In 1988, Becker and Gilbert introduced a Fasciocutaneous pedicled flap based on a consistent dorsal perforator of the ulnar artery (absent in 1 % of population) named the dorsal ulnar artery (DUA) flap or simply the Becker flap. The authors described open revision CTR with nerve coverage by a DUA flap in 3 patients with recurrent CTS and reported good results as well as a quick and easy-to-perform dissection with low donor site morbidity and preservation of the radial andulnar artery. Since this introduction, additional studies describing fasciocutaneous DUA flaps have mostly focused on its use for reconstruction of hand or wrist wounds. Despite the original described benefits, additional studies of DUA flaps for the treatment of recurrent or persistent CTS have remained limited.
- Conditions
- Failed Carpal Tunnel Syndrome Surgery
- Being tested
- Treatment of failed carpal tunnel syndrome by dorsal ulnar artery perforator adipofascial flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of failed carpal tunnel syndrome by dorsal ulnar artery perforator adipofascial flapProcedure or surgery
Treatment of failed carpal tunnel syndrome by dorsal ulnar artery perforator adipofascial flap The previous incision is reopened and extended, Neurolysis begins proximally preserving the palmar cutaneous branch. The subcutaneous tissue is exposed, leaving part of the superficial venous plexus with the adipofascial flap. Flap elevation is begun by incising the subcutaneous tissue through the deep fascia along the radial border of FCU and ECU .
When the flap reaches a suitable length (10-12 cm from the wrist), it is cut proximally and along the ulnar side. The flap is dissected proximally to distally in continuity with the underlying fascia . When the dissected flap is (2-5) cm proximal to the wrist. Ulnar retraction of the flexor carpi ulnaris permits identification of the perforator. the pivot point of the flap is localized (2-5) cm proximal to the pisiform.
The adipofascial flap is turned 180 degrees and anchored with a few absorbable stitches around the median nerve.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain visual analogue scale (VAS)
The visual analog scale for pain is a straight line with one end meaning no pain and the other end .meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".the position of the respondent's cross is generally assigned a score between 0 and 100. If documented in paper form, the scores can then be simply transferred to a 100-value scale using a millimeter tape measure
Measured: 1 year
Secondary outcomes (2)
Two point discrimination test
one of the most commonly used neurosensory tests to assess mechanoperception in the clinical settings. While there have been numerous studies of functional sensibility of the hand using TPD test.
Measured: 1 year
Tinel sign
a tingling or "pins and needles" feeling you get when your healthcare provider taps your skin over a nerve. Tinel's sign may be an indicator that you have nerve compression or damage where they're tapping
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Mar 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Failed Carpal Tunnel Syndrome SurgeryStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shehata Gaber, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324617
- Sponsor's protocol ID
- soh-Med-24-02-06MS
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bollmann G, Bouvet C, Beaulieu JY. Recurrent carpal tunnel syndrome: Outcomes after neurolysis and synovial flap. Hand Surg Rehabil. 2023 Jun;42(3):236-242. doi: 10.1016/j.hansur.2023.04.004. Epub 2023 Apr 25.
PubMed 37105520Neuhaus V, Christoforou D, Cheriyan T, Mudgal CS. Evaluation and treatment of failed carpal tunnel release. Orthop Clin North Am. 2012 Oct;43(4):439-47. doi: 10.1016/j.ocl.2012.07.013. Epub 2012 Aug 30.
PubMed 23026459Lauder A, Mithani S, Leversedge FJ. Management of Recalcitrant Carpal Tunnel Syndrome. J Am Acad Orthop Surg. 2019 Aug 1;27(15):551-562. doi: 10.5435/JAAOS-D-18-00004.
PubMed 30973521Botte MJ, von Schroeder HP, Abrams RA, Gellman H. Recurrent carpal tunnel syndrome. Hand Clin. 1996 Nov;12(4):731-43.
PubMed 8953292
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Failed Carpal Tunnel Syndrome by Dorsal Ulnar Artery Perforator Adipofascial Flap
- ClinicalTrials.gov ID
- NCT06324617
- Acronym / sponsor ID
- soh-Med-24-02-06MS
- Conditions
- Failed Carpal Tunnel Syndrome Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Mar 2024 (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.
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the general population. Surgical treatment by open or endoscopic carpal tunnel release (CTR) is the first choice of treatment and has clinical success rates of 75% to 90%.The rate of recurrence after primary median nerve release is 3-19% [1,2]. Between 0.3% and 12% of cases require surgical revision [2,3]. The risk factors for surgical revision for secondary release are male gender, staged or simultaneous bilateral carpal tunnel release, endoscopic release, smoking and rheumatoid arthritis.
Treatment failures after primary CTR are classified as persistent CTS, recurrent CTS, or new symptoms. Recurrent symptoms are uncommon and are defined by a symptom-free interval after surgery. Persistent symptoms are relatively common, particularly in elderly patients and in patients with concurrent nerve compression or medical conditions that affect nerve function, such as diabetes. Persistent or recurrent CTS principally results from incomplete release of the transverse carpal ligament but may be accompanied by perineural scarring, leading to compression or tethering of the median nerve.
New symptoms may be caused by iatrogenic nerve injury. Surgical treatment of recurrent or persistent CTS after primary CTR usually involves open revision CTR, extended proximally into unscarred tissue, and has also included internal or external neurolysis. Unsatisfactory results following revision CTR are common.
A second compression site, or double-crush syndrome, may clinically present as RCTS or PCTS . Thorough preoperative clinical examination may uncover signs of a second compression site, which can then be confirmed on electroneuromyography (ENMG) of the entire arm.
To improve outcomes of revision CTR, recent studies have emphasized the importance of median nerve coverage by well-vascularized soft tissue to enhance nerve healing, to prevent tethering in surrounding scar tissue, and to optimize nerve gliding in the carpal tunnel. Several local flaps (hypothenar fat pad flap, tenosynovial flap), regional flaps (posterior interosseous artery flap, reverse radial artery fascial flap, flexor digitorum superficialis flap), and free flap techniques have been described, but consensus for specific flap has not been reached. Following potential iatrogenic median nerve injury and reexploration for a painful neuroma incontinuity, flap coverage may also be beneficial.
In 1988, Becker and Gilbert introduced a Fasciocutaneous pedicled flap based on a consistent dorsal perforator of the ulnar artery (absent in 1 % of population) named the dorsal ulnar artery (DUA) flap or simply the Becker flap. The authors described open revision CTR with nerve coverage by a DUA flap in 3 patients with recurrent CTS and reported good results as well as a quick and easy-to-perform dissection with low donor site morbidity and preservation of the radial andulnar artery. Since this introduction, additional studies describing fasciocutaneous DUA flaps have mostly focused on its use for reconstruction of hand or wrist wounds. Despite the original described benefits, additional studies of DUA flaps for the treatment of recurrent or persistent CTS have remained limited.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 years
- Positive tinel sign
- Operative interval more than 3 months \& less than 2 years
Key exclusion criteria (2 listed)
- Cervical disc
- Associated general disease (Rheumatoid arthritis, DM ,psychological problems \& peripheral neuropathy)
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 |
|---|---|---|
| Treatment of failed carpal tunnel syndrome by dorsal ulnar artery perforator adipofascial flapTreatment of failed carpal tunnel syndrome by dorsal ulnar artery perforator adipofascial flap The previous incision is reopened and extended, Neurolysis begins proximally preserving the palmar cutaneous branch. The subcutaneous tissue is exposed, leaving part of the superficial venous plexus with the adipofascial flap. Flap elevation is begun by incising the subcutaneous tissue through the deep fascia along the radial border of FCU and ECU . When the flap reaches a suitable length (10-12 cm from the wrist), it is cut proximally and along the ulnar side. The flap is dissected proximally to distally in continuity with the underlying fascia . When the dissected flap is (2-5) cm proximal to the wrist. Ulnar retraction of the flexor carpi ulnaris permits identification of the perforator. the pivot point of the flap is localized (2-5) cm proximal to the pisiform. The adipofascial flap is turned 180 degrees and anchored with a few absorbable stitches around the median nerve. | Procedure or surgery | – |
Primary outcome
Pain visual analogue scale (VAS)
Time frame: 1 year
The visual analog scale for pain is a straight line with one end meaning no pain and the other end .meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".the position of the respondent's cross is generally assigned a score between 0 and 100. If documented in paper form, the scores can then be simply transferred to a 100-value scale using a millimeter tape measure
2 secondary outcomes
Two point discrimination test
Time frame: 1 year
Tinel sign
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Background: PubMed 37105520Bollmann G, Bouvet C, Beaulieu JY. Recurrent carpal tunnel syndrome: Outcomes after neurolysis and synovial flap. Hand Surg Rehabil. 2023 Jun;42(3):236-242. doi: 10.1016/j.hansur.2023.04.004. Epub 2023 Apr 25.
- Background: PubMed 23026459Neuhaus V, Christoforou D, Cheriyan T, Mudgal CS. Evaluation and treatment of failed carpal tunnel release. Orthop Clin North Am. 2012 Oct;43(4):439-47. doi: 10.1016/j.ocl.2012.07.013. Epub 2012 Aug 30.
- Background: PubMed 30973521Lauder A, Mithani S, Leversedge FJ. Management of Recalcitrant Carpal Tunnel Syndrome. J Am Acad Orthop Surg. 2019 Aug 1;27(15):551-562. doi: 10.5435/JAAOS-D-18-00004.
- Background: PubMed 8953292Botte MJ, von Schroeder HP, Abrams RA, Gellman H. Recurrent carpal tunnel syndrome. Hand Clin. 1996 Nov;12(4):731-43.
- Individual participant dataSharing planned: Undecided
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.
Hassan H Noman, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of failed carpal tunnel syndrome by dorsal ulnar artery perforator adipofascial flap in people with Failed Carpal Tunnel Syndrome Surgery, run by Sohag 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed S Abd-Ellah, specialist (01001198306, mohamed.abdelah@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain visual analogue scale (VAS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06324617, which also lists 4 linked publications.
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 22 Mar 2024.