Internal Brace vs. Ligament Reconstruction for Thumb Arthritis

Overseen By Charles Day, MD MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: Cardiac, Renal, Liver, Pulmonary, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day (surgical procedure)

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different surgeries for treating thumb arthritis. One group will undergo the standard surgery, which involves removing a bone in the thumb and replacing it with a tendon graft. The other group will try a new method using a device called the InternalBrace, which connects thumb bones with strong tape (known as Suture Tape Reconstruction). This trial is for patients with thumb arthritis that hasn't improved with other treatments and who are part of the Henry Ford Orthopedic Service Line. As an unphased trial, it offers patients the chance to explore innovative surgical options that could enhance their quality of life.

Will I have to stop taking my current medications?

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

What prior data suggests that the InternalBrace device is safe for thumb arthritis treatment?

Research shows that the InternalBrace device, used with suture tape reconstruction, has promising short-term results for treating thumb arthritis. This device supports the thumb after bone removal. Although detailed safety data is not yet available, its study suggests some confidence in its safety.

The InternalBrace, a type of surgical support system, has been used in other surgeries, leading doctors to believe it is safe. Generally, similar treatments have not reported major safety issues. Early findings suggest that patients tolerate this procedure well. However, discussing specific safety details and possible risks with the trial team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the suture tape reconstruction for thumb arthritis because it introduces a novel approach to stabilizing the thumb joint. Unlike traditional methods like ligament reconstruction with tendon interposition, this technique uses an Arthrex InternalBrace device to secure the 1st metacarpal to the 2nd. This method offers the potential for greater joint stability and faster recovery, as it avoids the need for tendon harvesting and uses a minimally invasive approach. By potentially reducing recovery time and improving joint function, this innovative technique could offer significant advantages over existing treatments.

What evidence suggests that the InternalBrace device is effective for thumb arthritis?

Research shows that the InternalBrace device, which participants in this trial may receive, effectively treats thumb arthritis. This device stabilizes the thumb by using a special tape to connect bones, providing extra support. Some studies have shown promising short-term results with this method. It strengthens the area around the thumb joint and supports the ligaments. Although long-term data collection continues, early findings suggest that this technique may improve grip strength and reduce pain for people with thumb arthritis. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients under the care of Henry Ford Orthopedic Service Line with painful thumb arthritis that hasn't improved with standard treatments. It's not suitable for those with serious health issues like heart, kidney, liver, or lung diseases, or heavy substance abuse. People needing other thumb joint procedures can't join.

Inclusion Criteria

My thumb arthritis pain persists despite treatment.

Patients of Henry Ford Orthopedic Service Line

Exclusion Criteria

I have a serious health condition that makes surgery unsafe for me.

I need surgery on my thumb joint but not for carpal tunnel or trigger fingers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo trapeziectomy with either ligament reconstruction and tendon interposition or suture tape suspension using the InternalBrace device

1 day (surgical procedure)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of upper extremity function and pinch strength

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Suture Tape Reconstruction

Trial Overview The study compares two surgical techniques for thumb arthritis after removing a wrist bone (trapeziectomy). One group receives a tendon graft (control), while the other uses an InternalBrace device to connect thumb and index finger bones (experimental).

How Is the Trial Designed?

Group I: Carpometacarpal (CMC) Suture Tape Ligament Reconstruction Experimental Treatment 1 Intervention

Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group.

Group II: Carpometacarpal (CMC) Standard Ligament Reconstruction Active Control 1 Intervention

Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/88/NCT03971188/Prot_SAP_000.pdf

LRTI versus InternalBrace for the Surgical Treatment of ... been used at our institution for thumb CMC OA with encouraging outcomes in the short- term (unpublished data). The IB procedure allows the patient to forego ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05753891

Trapeziectomy: Internal Brace vs. Ligament Reconstruction ... This study seeks to compare two methods of trapeziectomy for basilar thumb arthritis. The first is trapeziectomy with ligament reconstruction and tendon ...

3. arthrex.com arthrex.com/resources/DOC1-000450-en-US/hand-and-wrist-internalbrace-repair-scientific-update

Hand and Wrist InternalBrace™ Repair Scientific Update The InternalBrace surgical technique is intended only to augment the primary repair/ reconstruction by expanding the area of tissue.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38934993/

One-Year Outcomes of Ligament Reconstruction Tendon ... We performed a randomized controlled trial assessing patient-reported outcome measures following trapeziectomy with ligament reconstruction and tendon ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352587824000020

Ligament reconstruction in thumb carpometacarpal joint ... This systematic review outlines the available ligament reconstruction techniques and their efficacy in treating nontraumatic and nonarthritic CMC instability.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38106952/

Trapeziectomy with Ligament Reconstruction The purpose of this study was to compare patient outcomes following TRS versus STS for treatment of thumb CMC OA.

7. researchgate.net researchgate.net/publication/381750920_A_Prospective_Randomized_Pilot_Study_One-Year_Outcomes_of_Ligament_Reconstruction_Tendon_Interposition_Versus_Suture_Tape_Suspensionplasty_for_Thumb_Carpometacarpal_Joint_Arthritis

One-Year Outcomes of Ligament Reconstruction Tendon ... A Prospective Randomized Pilot Study: One-Year Outcomes of Ligament Reconstruction Tendon Interposition Versus Suture Tape Suspensionplasty for Thumb ...