NCT06133920 Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
| NCT ID | NCT06133920 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cooper Health System |
| Condition | Proximal Humeral Fracture |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-02-24 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2021-02-24 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate compare postoperative range of motion in patients who are given a sling for comfort only and allowed to start early active range of motion compared to patients who are placed in a sling for 4 weeks with passive range of motion only. Once enrolled, the patients will be randomized through computer randomization then placed in paper packets into either the immobilization group or the early range of motion group.
Eligibility Criteria
Inclusion Criteria: * Patients 60 years or older who have a displaced proximal humerus fracture * Meets surgical criteria for a reverse total shoulder arthroplasty * Receive surgical intervention within 6 weeks of initial injury Exclusion Criteria: * Patients \<60 years in age * Patients who cannot undergo surgery due to medical comorbidities * Patients who receive surgical intervention after 6 weeks from initial injury * Patients who have preoperative nerve damage from their fractures that would limit the ability to move the arm postoperatively
Contact & Investigator
Catherine J Fedorka, MD
PRINCIPAL INVESTIGATOR
Cooper Hospital Orthopedic Surgery
Frequently Asked Questions
Who can join the NCT06133920 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Proximal Humeral Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06133920 currently recruiting?
Yes, NCT06133920 is actively recruiting participants. Contact the research team at gentile-pietro@CooperHealth.edu for enrollment information.
Where is the NCT06133920 trial being conducted?
This trial is being conducted at Camden, United States.
Who is sponsoring the NCT06133920 clinical trial?
NCT06133920 is sponsored by The Cooper Health System. The principal investigator is Catherine J Fedorka, MD at Cooper Hospital Orthopedic Surgery. The trial plans to enroll 40 participants.