What side effects are associated with this type of intervention?

Common treatments for thumb osteoarthritis, such as trapeziectomy with ligament reconstruction and tendon interposition (LRTI), and newer approaches like Internal Brace (IB) Stabilization, can have side effects including pain, swelling, and potential complications like infection or nerve damage. Prolonged postoperative immobilization is often required for LRTI, which can limit daily activities. Non-surgical treatments like NSAIDs may cause gastrointestinal, renal, and cardiovascular issues. IB Stabilization aims to provide structural support and potentially allows for quicker recovery and return to activity, but further studies are needed to fully understand its side effects.

What prior FDA approvals exist?

Thumb osteoarthritis is commonly treated with procedures like trapeziectomy with ligament reconstruction and tendon interposition (LRTI), which is a well-established method requiring prolonged immobilization. A novel alternative, trapezium excision with Internal Brace (IB) stabilization, is being studied for its potential to provide structural support to the thumb joint and allow for quicker recovery and return to activity. While specific FDA approvals for these treatments are not detailed in the provided context, these procedures represent the current surgical approaches being explored and utilized for managing thumb osteoarthritis.

What other types of research exist?

A promising novel alternative to Internal Brace (IB) Stabilization for Thumb Osteoarthritis (CMC OA) patients is Trapeziectomy with Ligament Reconstruction and Tendon Interposition (LRTI). While LRTI is the current standard, ongoing research aims to compare its outcomes with IB stabilization. The goal is to determine if IB can provide superior short-term patient-reported outcomes and expedited return to work/activity. As of now, IB stabilization itself is considered a novel and promising alternative to traditional LRTI.

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Procedure

Internal Brace vs LRTI for Thumb Osteoarthritis

N/A

Waitlist Available

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Summary

This trial is studying a new treatment for thumb arthritis that involves removing a small bone and using an internal brace to stabilize the joint. The goal is to help patients recover faster and return to their daily activities sooner. The study will compare this new method to the traditional surgery to see which one works better.

Who is the study for?

This trial is for individuals over 50 years old with thumb osteoarthritis, specifically at the carpometacarpal joint. It's not suitable for those with rheumatoid or inflammatory arthritis, surgical treatment of thumb hyperextension, or a history of chronic opioid use.

What is being tested?

The study compares two surgeries for thumb osteoarthritis: traditional ligament reconstruction and tendon interposition (LRTI) versus a newer method using an internal brace (IB). The goal is to see if IB allows patients to return to daily activities and work sooner than LRTI.

What are the potential side effects?

Potential side effects may include pain at the surgery site, reduced thumb movement, weakness in grip or pinch strength, complications leading to additional surgery, and other general risks associated with hand surgeries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Follow-up retention rate

Randomization rate

Secondary study objectives

Complications

Grip Strength

Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity and Physical Function scores

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Internal BraceExperimental Treatment1 Intervention

Patients will undergo Internal Brace procedure for thumb CMC OA.

Group II: LRTIActive Control1 Intervention

Patients will undergo ligament reconstruction tendon interposition (most commonly performed surgery for thumb CMC OA) and serve as control group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trapeziectomy with Internal Brace

2020

N/A

~30

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Thumb Osteoarthritis (CMC OA) include Trapeziectomy with Ligament Reconstruction and Tendon Interposition (LRTI) and the novel Internal Brace (IB) Stabilization. LRTI involves removing the trapezium bone and using a tendon to reconstruct the ligament, providing stability but requiring prolonged immobilization. In contrast, IB Stabilization also involves trapezium excision but uses an internal brace to provide immediate structural support to the thumb joint. This support potentially allows for quicker recovery and a faster return to daily activities. The mechanism of providing immediate stability is crucial for patients as it can reduce downtime and improve functional outcomes more rapidly compared to traditional methods.

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,970 Previous Clinical Trials

2,308,593 Total Patients Enrolled

Media Library

Trapeziectomy with Internal Brace (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03971188 — N/A

Thumb Osteoarthritis Research Study Groups: LRTI, Internal Brace

Thumb Osteoarthritis Clinical Trial 2023: Trapeziectomy with Internal Brace Highlights & Side Effects. Trial Name: NCT03971188 — N/A

Trapeziectomy with Internal Brace (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03971188 — N/A

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