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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Mohamed S Abd-Ellah, specialist contact

01001198306

mohamed.abdelah@med.sohag.edu.eg

Hassan H Noman, MD contact

Egypt1 site, 1 recruiting
  • Sohag university Hospital

    Sohag

    Magdy M Amin, professor

    Recruiting

Other trials in Egypt

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.

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.

  1. 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)
  1. 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

  2. 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.

  1. First posted22 Mar 2024
  2. Study start1 Mar 2024
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

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)
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 37105520
  • Neuhaus 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 23026459
  • Lauder 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 30973521
  • Botte MJ, von Schroeder HP, Abrams RA, Gellman H. Recurrent carpal tunnel syndrome. Hand Clin. 1996 Nov;12(4):731-43.

    PubMed 8953292

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.

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