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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks, 4 weeks, 12 weeks, 24 weeks
Awards & highlights

Study Summary

This trial is testing whether it is better to have surgery for a broken wrist followed by a splint and physical therapy, or just surgery.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Loss of fixation
Secondary outcome measures
Change in Grip strength
Change in Patient comfort/pain (VAS)
Change in wrist range mobility
+1 more

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.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,363 Previous Clinical Trials
816,166 Total Patients Enrolled
Louis CatalanoPrincipal InvestigatorNYU Langone
Jadie De Tolla, MDPrincipal InvestigatorNYU Langone Health

Media Library

Self directed physical therapy Clinical Trial Eligibility Overview. Trial Name: NCT04324580 — N/A
Distal Radius Fracture Research Study Groups: Immediate mobilization/self guided physical therapy group, Delayed mobilization/Formal physical therapy group
Distal Radius Fracture Clinical Trial 2023: Self directed physical therapy Highlights & Side Effects. Trial Name: NCT04324580 — N/A
Self directed physical therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04324580 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to join this research endeavor?

"The current cohort of this medical trial consists of 250 individuals ranging in age from 18 to 75 with isolated displaced distal radius fractures. These participants must display greater than 10 degrees dorsal tilt and have been treated using volar locked plating and screws, as well as exhibiting an ulnar styloid fracture (if present)."

Answered by AI

Does this research include adults aged 18 and older?

"Patients of legal age, who are above 18 and below 75 years old, may be eligible to join this medical trial."

Answered by AI

Are healthcare professionals currently seeking participants for the experiment?

"Affirmative. According to the information housed on clinicaltrials.gov, this research study is actively enrolling patients as of March 4th 2022. It was first posted on June 18th 2020 and requires 250 participants from a single laboratory site.."

Answered by AI

How extensive is the current enrollment of this research trial?

"Affirmative. Clinicaltrials.gov verifies that this experiment, which was published on June 18th 2020, is currently recruiting individuals to participate. Approximately 250 volunteers are required from a single medical centre."

Answered by AI
~11 spots leftby Jun 2024