Ultrasound-Guided vs. Mini-Open Surgery for Carpal Tunnel Syndrome

Overseen By Matthew Miller, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Walter Reed National Military Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Previous wrist surgery, CRPS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Day 0

41 Participants Needed

Trial Summary

What is the purpose of this trial?

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and affects 3-6% of adults in the United States. In patients with severe or refractory symptoms, carpal tunnel release (CTR) represents the definitive management option, and over 550,000 CTRs are performed annually in the United States with over 90% of patients reporting clinical improvement. Currently available CTR techniques include mini-open CTR via a single, 1-3 cm palmar incision (mOCTR), endoscopic CTR via one (wrist) or two (wrist and palm) 1-2 cm incisions (ECTR), and ultrasound guided CTR via a single \< 1 cm wrist or palmar incision (USCTR or CTR-US). The primary objective is to assess the impact of USCTR vs mOCTR in a military population. Investigators hypothesize that USCTR using the SX-One MicroKnife, also known as UltraGuideCTR, will safely and non-inferiorly improve symptoms of carpal tunnel syndrome compared to traditional mOCTR, without greater less loss of military duty days. This study is a single-site randomized controlled trial. Participants with CTS will be randomized to a study arm and receive treatment with USCTR vs. traditional mOCTR. All patients will be followed for a period of 24 months with respect to standard clinical data, military relevant data, and validated patient related outcome measures (PROMs). Data will be collected at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, and 12 months, and 24 months post-CTR procedure, with the primary focus being on outcomes up to 1 year.

Will I have to stop taking my current medications?

The trial requires that participants stop taking anticoagulation medications (blood thinners) like Plavix, Coumadin/Warfarin, and Xarelto, unless they can be temporarily replaced with Lovenox.

What data supports the effectiveness of the treatment for carpal tunnel syndrome?

Research shows that ultrasound-guided carpal tunnel release (USCTR) can lead to faster recovery compared to traditional mini-open surgery, with reports of excellent results and reduced recovery times. This suggests that USCTR is an effective treatment option for carpal tunnel syndrome. ^{1 2 3 4 5}

Is ultrasound-guided carpal tunnel release safe for humans?

Research shows that ultrasound-guided carpal tunnel release (USCTR) is generally safe, with no serious adverse events reported in studies. It has been used successfully for carpal tunnel syndrome, and patients often experience faster recovery compared to traditional methods. ^{4 5 6 7 8}

How does the ultrasound-guided treatment for carpal tunnel syndrome differ from other treatments?

The ultrasound-guided treatment for carpal tunnel syndrome is unique because it involves a minimally invasive approach that uses ultrasound to guide the release of the carpal tunnel, resulting in smaller incisions, less recovery time, and reduced postoperative pain compared to traditional mini-open surgery. ^{1 4 5 9 10}

Research Team

Matthew Miller, MD

Principal Investigator

Walter Reed National Military Medical Center

Eligibility Criteria

This trial is for adults over 18 with severe or persistent Carpal Tunnel Syndrome (CTS), confirmed by tests showing nerve issues at the wrist. They must speak English and be eligible for military healthcare. People can't join if they've had previous CTS surgery, can't stop blood thinners, have had certain injuries or conditions affecting the arm, or received a recent steroid injection in the carpal tunnel.

Inclusion Criteria

DEERS Eligible

Fluent in speaking, reading, and understanding English

Candidate for surgical CTR based on severe and/or refractory symptoms

Exclusion Criteria

Unable to understand and provide written informed consent

Previous carpal tunnel release or previous wrist surgery on the ipsilateral side

Inability to stop anticoagulation medications (Plavix, Coumadin/Warfarin, Xarelto), or unable to be bridged with Lovenox

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the USCTR or mOCTR procedure

Day 0

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Multiple visits at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months

Treatment Details

Interventions

• mOCTR
• USCTR

Trial Overview The study compares two surgical techniques for CTS: ultrasound-guided carpal tunnel release (USCTR) using SX-One MicroKnife® versus traditional mini-open release (mOCTR). Participants will be randomly assigned to one of these treatments and followed up for two years to measure recovery and effectiveness.

Participant Groups

Group I: USCTR Procedure Experimental Treatment 1 Intervention

Participants will undergo the USCTR procedure with SX-One MicroKnife®, also known as UltraGuideCTR

Group II: mOCTR Procedure Active Control 1 Intervention

Participants will undergo the traditional mOCTR procedure.

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials

149

Recruited

33,800+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

References

1. United States pubmed.ncbi.nlm.nih.gov

Minimally invasive ultrasound-guided vs open release for carpal tunnel syndrome in working population: A randomized controlled trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided carpal tunnel release using the manos CTR system. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Multicenter pragmatic study of carpal tunnel release with ultrasound guidance. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Sonographic Changes After Ultrasound-Guided Release of the Transverse Carpal Ligament: A Case Report. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided percutaneous carpal tunnel release: A systematic review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Clinical Results of Ultrasound-Guided Carpal Tunnel Release Performed by a Primary Care Sports Medicine Physician. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Interventions for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analyses. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Ultra-Minimally Invasive Ultrasound-Guided Carpal Tunnel Release: A Randomized Clinical Trial. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison efficacy of ultrasound-guided needle release plus corticosteroid injection and mini-open surgery in patients with carpal tunnel syndrome. [2023]