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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical methods for treating carpal tunnel syndrome (CTS), a condition causing numbness and tingling in the hand. Researchers aim to determine if ultrasound-guided surgery (USCTR) is as effective as traditional mini-open surgery (mOCTR) in improving symptoms. Participants will be randomly assigned to one of the two surgeries and monitored for up to two years to assess their recovery and any impact on military duties. Ideal candidates are adults diagnosed with severe or persistent CTS that hasn't improved with other treatments. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future treatment options for CTS.

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 prior data suggests that these procedures are safe for carpal tunnel syndrome?

Studies have shown that ultrasound-guided carpal tunnel release (USCTR) is a safe and effective treatment for carpal tunnel syndrome. Research indicates that patients who underwent this procedure reported high satisfaction just 1 to 2 weeks post-surgery. Specifically, another study found that USCTR significantly improved symptoms within the first few weeks, making it a well-tolerated option.

While USCTR is the newer method under investigation, the mini-open carpal tunnel release (mOCTR) is already a common and trusted procedure. Both techniques aim to relieve pressure on the median nerve in the wrist, easing symptoms. USCTR involves a small incision and uses real-time ultrasound to guide the procedure, allowing doctors to visualize important structures in the wrist.

Overall, both treatments have a history of safety. The USCTR method is gaining attention for its less invasive approach and quick recovery times. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for carpal tunnel syndrome because they offer promising alternatives to traditional surgery. The USCTR procedure is particularly intriguing because it uses the SX-One MicroKnife® or UltraGuideCTR, allowing for a minimally invasive approach with ultrasound guidance. This method potentially reduces recovery time and minimizes scarring compared to the traditional mini-open carpal tunnel release (mOCTR). By offering less invasive options, these new procedures aim to improve patient outcomes and comfort.

What evidence suggests that this trial's treatments could be effective for carpal tunnel syndrome?

This trial will compare ultrasound-guided carpal tunnel release (USCTR) with the mini-open carpal tunnel release (mOCTR) procedure. Research has shown that USCTR is safe and effective. Patients report high satisfaction, with noticeable improvements in just 1 to 2 weeks. Benefits such as improved hand function and reduced discomfort often persist for over a year. The SX-One MicroKnife used in USCTR enhances efficiency, enabling quicker recovery compared to traditional surgeries. ^{1 4 5 6 7}

Who Is on the Research Team?

Matthew Miller, MD

Principal Investigator

Walter Reed National Military Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/jum.15120

Clinical Results of Ultrasound‐Guided Carpal Tunnel ...

Mean global satisfaction scores at 1 to 2 weeks and 3 months were 4.63 and 4.66. Conclusions. Ultrasound-guided CTR is a safe and effective ...

2.

sonexhealth.com

sonexhealth.com/physicians/carpal-tunnel-release-with-ultrasound-guidance/

Carpal Tunnel Release with Ultrasound Guidance

Traditional open and endoscopic carpal tunnel release (CTR) procedures are effective but may result in a lengthy recovery period and a large and sometimes ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9608268/

Long-term Clinical Results of Carpal Tunnel Release ...

CTR using ultrasound (US) guidance is a safe and effective procedure that produces statistically and clinically significant improvements within 1 to 2 weeks ...

4.

sonexhealth.com

sonexhealth.com/educational-institute/scientific-presentations/

Scientific Presentations

The author also reported significant improvements in practice efficiency due to implementation of CTR using the SX-One MicroKnife and ultrasound guidance.

5.

ajronline.org

ajronline.org/doi/10.2214/AJR.20.24383

Minimally Invasive Ultrasound-Guided Carpal Tunnel ...

Ultrasound-guided carpal tunnel release quickly improves hand function and reduces hand discomfort; improvement persists beyond 1 year.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04504019

NCT04504019 | Clinical Outcomes of USCTR vs. mOCTR

Investigators hypothesize that USCTR using the SX-One MicroKnife, also known as UltraGuideCTR, will safely and non-inferiorly improve symptoms of carpal tunnel ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05031338

NCT05031338 | Carpal Tunnel Release Using Ultrasound

Minimally Invasive Ultrasound-Guided Carpal Tunnel Release Improves Long-Term Clinical Outcomes in Carpal Tunnel Syndrome. AJR Am J Roentgenol. 2021 Aug;217 ...