2000 Participants Needed

Carpal Tunnel Release for Carpal Tunnel Syndrome

(MISSION Trial)

Recruiting at 54 trial locations
CB
AJ
AS
Overseen ByAmy Stegner
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sonex Health, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial gathers real-world data on carpal tunnel release (CTR) surgeries to better understand patient experiences. It compares three surgery methods: ultrasound-guided, open, and endoscopic. The goal is to assess how each method affects recovery and outcomes over time. Individuals with diagnosed carpal tunnel syndrome (characterized by pain and numbness in the hand due to nerve compression) who have not found relief from other treatments might be suitable candidates. Participants must be willing to complete follow-up surveys for two years. As an unphased trial, this study offers participants the chance to contribute valuable insights that could enhance future treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ultrasound-guided carpal tunnel release (CTR-US) is safe and effective. Studies find it easy for patients to handle, providing long-lasting symptom relief with a low risk of complications. Patients report high satisfaction with this method.

For open carpal tunnel release (OCTR), evidence suggests it is a reliable and safe option. Many patients experience significant symptom reduction, and the procedure has a strong safety record with fewer complications.

Endoscopic carpal tunnel release (ECTR) is also considered safe. Patients often experience less post-surgery pain and report higher satisfaction. However, there is a slightly higher chance of temporary nerve issues compared to open surgery. Overall, all these methods are regarded as safe, each with its own benefits and risks.12345

Why are researchers excited about this trial?

Researchers are excited about these methods for carpal tunnel release because they offer less invasive options compared to traditional surgery. The Ultrasound Guided Carpal Tunnel Release (CTR-US) technique uses imaging to precisely guide the procedure, potentially reducing recovery time and minimizing scarring. The Endoscopic Carpal Tunnel Release (ECTR) allows for a smaller incision, which can lead to quicker healing and less post-operative discomfort. These innovative approaches aim to improve patient outcomes and enhance the overall experience compared to the standard open surgical method.

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

This trial will compare three techniques for carpal tunnel release: Ultrasound Guided Carpal Tunnel Release (CTR-US), Open Carpal Tunnel Release (OCTR), and Endoscopic Carpal Tunnel Release (ECTR). Research has shown that ultrasound-guided carpal tunnel release (CTR-US) is safe and effective, with benefits lasting up to 6 years. Six months post-procedure, about 94% of patients reported satisfaction. Open carpal tunnel release (OCTR) has shown good long-term results, with a success rate of 75% to 90%. In some cases, endoscopic carpal tunnel release (ECTR) performs even better, with 82% of patients experiencing complete symptom relief and faster recovery. Both OCTR and ECTR are effective, but ECTR often results in better recovery and less scarring pain.16789

Who Is on the Research Team?

VM

Victor M Marwin, MD, MBA

Principal Investigator

Bluegrass Orthopaedics

Are You a Good Fit for This Trial?

Inclusion Criteria

A medical decision has been taken to perform ultrasound-guided carpal tunnel release with UltraGuideCTR on one or both hands.
You have a score over 12 on the CTS-6 in your target hand, indicating mild to moderate carpal tunnel syndrome.
Ultrasound diagnostic testing must confirm median nerve cross-sectional area of at least 10 mm2 in the proximal carpal tunnel region.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo carpal tunnel release using one of three techniques: Ultrasound guided, Endoscopic, or Open

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction after treatment

24 months
Regular follow-up visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

  • Endoscopic CTR
  • Open CTR
  • UltraGuideCTR with Ultrasound Guided Carpal Tunnel Release (CTR-US)

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Ultrasound Guided Carpal Tunnel Release (CTR-US)Experimental Treatment1 Intervention
Group II: Open Carpal Tunnel Release (OCTR)Experimental Treatment1 Intervention
Group III: Endoscopic Carpal Tunnel Release (ECTR)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sonex Health, Inc.

Lead Sponsor

Trials
4
Recruited
2,700+

Citations

Improved Surgical Outcomes With Endoscopic Carpal Tunnel ...

Treatment completely resolved CTS symptoms in 82% of ECTR cases and 39% of OCTR cases. Complication rates (all causes) were similar for both procedures.

Outcomes Following Endoscopic versus Open Carpal ...

However, patients undergoing ECTR have significantly lower rates of infection, wound complications, and readmission within 30 days. Despite the increased cost ...

Comparing the Efficacy of Endoscopic Carpal Tunnel ...

Both ECTR and OCTR are safe and effective in management of carpal tunnel syndrome. However, ECTR may be slightly superior in terms of scar pain ...

Best-Evidence Systematic Review and Meta-Analysis ...

In a best-evidence synthesis of contemporary studies, ECTR resulted in significant improvements in function and pain, with a low risk of conversion to open ...

Long-term outcomes following single-portal endoscopic ...

Based on individual L-K scores, 12 ECTR patients (15 of 115 hands, 13 %) had initial improvement of at least 0.5 points at 6 months postsurgery and then had a ...

Clinical Outcomes Following Endoscopic Carpal Tunnel ...

Endoscopic carpal tunnel release is also associated with less early postoperative pain, less scar tenderness, and higher patient satisfaction. Various ECTR ...

Revision Carpal Tunnel Release Following Endoscopic ...

Although outcomes data are lacking, revision CTR has been associated with unsatisfactory results, including persistence of symptoms and ...

Open Carpal Tunnel Release – still a safe and effective ...

Forty-seven patients (51 hands) underwent carpal tunnel release and 32 patients completed the questionnaire. 88% had a significant reduction in the symptom ...

Endoscopic versus open carpal tunnel release for idiopathic ...

The results clearly indicated that ECTR significantly increased the risk of reversible postoperative nerve injury as compared with OCTR, while ...