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Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

230 Participants Needed

Splinting and Physical Therapy After Surgery for Wrist Fractures

Overseen ByVictoria Comunale

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Upper limb fracture, Dislocation, Neurologic injury, others

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment for wrist fractures?

Research shows that both formal physical therapy and home exercise programs can be effective after wrist surgery, with significant improvements in self-assessed parameters and functional scores. Additionally, early motion techniques and splinting are important for recovery, helping to reduce pain and improve function.¹ ² ³ ⁴ ⁵

Is splinting and physical therapy after wrist surgery safe?

Research indicates that using splints and physical therapy, including home exercise programs, is generally safe for treating wrist fractures. Studies show that fractures heal without significant complications, and splinting can be customized for safe recovery.¹ ⁴ ⁵ ⁶ ⁷

How is self-directed physical therapy different from other treatments for wrist fractures?

Self-directed physical therapy is unique because it allows patients to perform exercises at home without the need for frequent visits to a physical therapist, offering more flexibility and potentially reducing costs. This approach contrasts with traditional therapy, which typically involves multiple sessions with a therapist to guide recovery.¹ ⁵ ⁸ ⁹ ¹⁰

Research Team

Jadie De Tolla, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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)

Treatment Details

Interventions

Formal Physical Therapy
Self directed physical therapy
Soft dressing (No Splint)
Splint

Trial OverviewThe 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.

Participant Groups

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Casting acute fractures. Part 3--The volar slab.Spain, D.[2005]