Splinting and Physical Therapy After Surgery for Wrist Fractures

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JD
JD
PI
VC
Overseen ByVictoria Comunale
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
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 tests whether individuals with a specific type of wrist fracture heal better with or without a splint and formal physical therapy after surgery. It compares two groups: one performing self-directed physical therapy exercises and another attending professional therapy sessions. The goal is to determine if early wrist movement leads to better recovery without additional pain or complications. Individuals with wrist fractures involving shifts or gaps in bone alignment may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future treatment options for wrist fractures.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that splinting and physical therapy after wrist surgery are safe?

Previous studies have shown that performing physical therapy exercises at home is generally safe for treating wrist fractures. Patients often find these exercises as effective as visiting a therapist, with no serious safety issues reported.

Research also indicates that attending therapy sessions is safe and can improve movement and reduce pain after a wrist fracture. Both methods, whether done at home or with a therapist, are well-tolerated, and no major problems have been reported in these studies.

Overall, both home exercises and therapy sessions are considered safe options after wrist surgery.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different approaches to post-surgery rehabilitation for wrist fractures. Unlike the standard of care, which often involves a structured physical therapy program, the trial investigates both self-directed home exercises and more traditional supervised therapy. The immediate mobilization group allows patients to start moving their wrists right after surgery with the guidance of a simple pamphlet, promoting faster independence. Meanwhile, the delayed mobilization group utilizes custom splints and therapist-led sessions to provide a more controlled recovery process. By comparing these methods, researchers hope to identify which approach optimizes healing and restores wrist function most effectively.

What evidence suggests that this trial's treatments could be effective for wrist fractures?

This trial will compare immediate mobilization with self-guided physical therapy to delayed mobilization with formal physical therapy after wrist fracture surgery. Studies have shown that both home exercises and physical therapy sessions aid recovery from wrist fractures. Research indicates that a home exercise routine can lead to similar improvements in movement and strength as professional therapy sessions. One study found no significant differences in pain or grip strength between those attending therapy and those exercising at home. Therapy sessions can improve movement and reduce pain in the short term. However, not all studies agree, with some suggesting that therapy's benefits might not significantly surpass home exercises. Both options can be effective, depending on individual preference and available resources.46789

Who Is on the Research Team?

JD

Jadie De Tolla, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I had surgery for a broken wrist using plates and screws.
> 10 degrees of dorsal tilt
Shortening > 3 mm
See 2 more

Exclusion Criteria

I have had a dislocation or nerve injury.
I have a fracture in the same side arm.
My fracture was fixed using methods other than volar plating and screws.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo surgical fixation of distal radius fractures and initial recovery

2 weeks
1 visit (in-person)

Treatment

Participants follow either immediate mobilization with self-guided physical therapy or delayed mobilization with formal physical therapy

8 weeks
4 visits (in-person) for formal physical therapy group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of fixation, pain, range of motion, and grip strength

16 weeks
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Formal Physical Therapy
  • Self directed physical therapy
  • Soft dressing (No Splint)
  • Splint
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Immediate mobilization/self guided physical therapy groupActive Control2 Interventions
Group II: Delayed mobilization/Formal physical therapy groupActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Published Research Related to This Trial

A study involving 48 patients with distal radius fractures showed that those who followed an independent home exercise program had significantly better wrist functionality after 6 weeks compared to those receiving physical therapy, achieving 54% grip strength and 79% range of motion compared to their uninjured wrist.
The home exercise group also reported nearly 50% lower scores on the Patient Related Wrist Evaluation (PRWE), indicating better overall wrist function, suggesting that home-based rehabilitation can be an effective alternative to traditional physical therapy.
Physiotherapy after volar plating of wrist fractures is effective using a home exercise program.Krischak, GD., Krasteva, A., Schneider, F., et al.[2022]
In a study involving 300 participants aged 60 and older, there was no significant difference in wrist pain or function at 12 months between those treated surgically with a volar-locking plate and those treated nonsurgically with a cast.
Although patient-reported treatment success was higher in the surgical group, the overall outcomes for pain and quality of life were similar, suggesting that surgical intervention may not provide substantial benefits over nonsurgical treatment for this age group.
Surgical Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients: A Randomized Clinical Trial.Lawson, A., Naylor, JM., Buchbinder, R., et al.[2022]
The study provides a detailed technique for quickly applying a plaster of Paris volar slab, which is essential for immobilizing wrist and distal forearm injuries effectively.
This method ensures maximum comfort for the patient while allowing reasonable function of the injured limb, making it a practical approach for initial treatment.
Casting acute fractures. Part 3--The volar slab.Spain, D.[2005]

Citations

The relationship between hand therapy and long-term ...80% of participants underwent therapy; 70% did both supervised therapy and home exercises. Participants had a mean 9.2 supervised sessions over 14.2 weeks.
a randomized controlled trial with a 2-year follow-upAt the 6-week and 1-year follow-up, supervised physiotherapy was more effective for functional improvement and pain relief compared with a home exercise ...
Rehabilitation after Distal Radius FracturesSmart technology innovations, such as mobile applications, may be useful to provide home-based patient support in rehabilitation after distal radius fractures.
Therapist-Supervised Hand Therapy Versus Home ...There were no statistically significant differences between the final scores of the PRWHE, wrist or forearm motion, pain, or grip strength between groups.
Occupational Performance 1 Year After a Distal Radius ...This study highlights the importance of a holistic approach in occupational therapy for DRF patients, revealing that standard measurements might overlook key ...
Comparison of 24-Month Outcomes After Treatment for ...In this randomized clinical trial, there were no differences among the 4 treatment groups according to outcomes 24 months after fracture.
Comparison of 24-Month Outcomes After Treatment for ...This randomized clinical trial compares 24-month outcomes among older adults with distal radius fractures across 4 treatment groups: volar ...
Variation in the Use of Therapy following Distal Radius ...Results: Overall, 20.6% of patients received either physical or occupational therapy following DRF. Use of therapy varied by DRF treatment, and patients who ...
The Relationship between Hand Therapy and Long-Term...Data were collected for the Wrist and Radius Injury Surgical Trial, a multicenter, international, pragmatic, randomized trial of distal radius fracture ...
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