What side effects are associated with this type of intervention?

Common treatments for distal radius fractures, such as early mobilization and self-guided physical therapy, generally aim to facilitate quicker recovery and reduce costs. Potential side effects of these treatments include pain, swelling, and stiffness in the affected wrist. Immobilization, often used initially, can lead to muscle atrophy and joint stiffness if prolonged. Formal physical therapy, while beneficial, may cause temporary discomfort or pain during exercises. Overall, early mobilization and self-guided therapy are being studied for their potential to minimize these side effects while promoting faster recovery.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for distal radius fractures that focus on early mobilization and reducing costs by avoiding formal physical therapy. Generally, post-operative care for distal radius fractures may involve splinting and physical therapy, but the decision to use these methods varies by surgeon or institutional preference. The goal of early mobilization is to improve outcomes and decrease costs without increasing pain or compromising hardware fixation.

What other types of research exist?

One promising alternative to early mobilization for distal radius fracture patients is the use of functional electrical stimulation (FES). FES can help improve bone density and muscle strength, potentially aiding in quicker recovery. Another alternative is the use of advanced bracing techniques, such as functional or hinged bracing, which can provide stability while allowing for some movement, thus promoting healing without the need for formal physical therapy. Additionally, resistance training using lower extremity exercises may also be beneficial for those unable to participate in traditional walking programs.

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Splinting and Physical Therapy After Surgery for Wrist Fractures

N/A

Recruiting

Led By Louis Catalano

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Isolated displaced distal radius fractures, +/- ulnar styloid fracture, treated with volar locked plating and screws

Intra-articular displacement or step off > 2mm

Must not have

Dislocation or neurologic injury

Ipsilateral upper limb concomitant fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks, 4 weeks, 12 weeks, 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two ways to care for broken wrists after surgery: using a splint and formal physical therapy or not using a splint and doing self-guided exercises. It aims to find out which method helps patients heal better, costs less, and doesn't cause more pain or issues with the surgical hardware.

Who is the study for?

This trial is for individuals who have had surgery to fix a broken wrist (distal radius fracture) with specific criteria like displacement or tilt of the bone. They must not have other fractures in the same arm, different types of fixation, severe open fractures, or nerve injuries.

What is being tested?

The study is testing if wearing a splint and getting formal physical therapy after wrist surgery gives better results than no splint and self-directed exercises. It aims to see if moving the wrist early without professional therapy affects pain levels or hardware issues.

What are the potential side effects?

Potential side effects may include increased pain, difficulty in using the affected hand during recovery, and possibly complications related to how well the bones heal or stay fixed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery for a broken wrist using plates and screws.

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My joint injury involves bones misaligned by more than 2mm.

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I have a specific type of wrist fracture.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a dislocation or nerve injury.

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I have a fracture in the same side arm.

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My fracture was fixed using methods other than volar plating and screws.

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I have a severe open fracture.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks, 4 weeks, 12 weeks, 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks, 4 weeks, 12 weeks, 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 4 weeks, 12 weeks, 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Loss of fixation

Secondary study objectives

Change in Grip strength

Change in Patient comfort/pain (VAS)

Change in wrist range mobility

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Immediate mobilization/self guided physical therapy groupActive Control2 Interventions

Participants will be placed into a soft dressing after surgery. Participants will be asked to keep non-weight bearing (on the operated wrist) but no restrictions for range of motion, keeping the dressing in place until first post-operative visit at 2 weeks. This group will be given a pamphlet with detailed instructions and demonstrations in home exercises. Active range of motion and strengthening exercises will be performed twice daily for 20 minutes for a total of 8 weeks.

Group II: Delayed mobilization/Formal physical therapy groupActive Control2 Interventions

Participants will be placed into a volar-based plaster splint post-operatively. Participants will be asked to keep non-weight bearing (on the operated wrist) but no restrictions for range of motion, keeping the dressing in place until first post-operative visit at 2 weeks. After that, participants will be placed into a custom thermoplastic splint by a therapist. This will be worn for 5 weeks. Supervised physical therapy will be prescribed 1- 2 times per week for a total of 8 weeks along with a home exercise program. Active range of motion and strengthening exercises will be performed at home twice daily for 20 minutes for a total of 8 weeks. The splint will be removed only for formal and home physical therapy and hygiene.

0 / 7Eligibility criteria met

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 distal radius fractures include surgical fixation (open reduction internal fixation), immobilization with splints or casts, and physical therapy. Surgical fixation stabilizes the fracture using plates and screws, allowing for proper alignment and healing. Immobilization restricts movement to prevent further injury and supports the healing process. Early mobilization, as studied in trials, involves minimal use of splints and encourages self-guided physical therapy, which can facilitate quicker recovery by promoting blood flow and muscle activity, potentially reducing stiffness and improving function. This approach may also reduce healthcare costs by minimizing the need for formal physical therapy sessions. These mechanisms are crucial for patients as they aim to restore wrist function, reduce pain, and expedite return to daily activities.