Comparing immobilization duration after shoulder surgery for fractures
Immobilization Versus Early Range of Motion in Reverse Total Arthroplasty in Patients With Proximal Humerus Fractures
This study is testing if older patients who have shoulder surgery for fractures recover better with early movement compared to those who wear a sling for four weeks without moving their shoulder.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | The Cooper Health System Academic / other |
| Locations | 1 site (Camden, New Jersey) |
| Trial ID | NCT06133920 on ClinicalTrials.gov |
What this trial studies
This study evaluates the postoperative range of motion in older patients who have undergone reverse total shoulder arthroplasty for proximal humerus fractures. Patients will be randomized into two groups: one receiving a sling for comfort only with early active range of motion, and the other placed in a sling for four weeks with passive range of motion only. The aim is to determine if early mobilization affects recovery and complication rates compared to traditional immobilization methods. Data will be collected on surgical outcomes and patient recovery.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 years or older with a displaced proximal humerus fracture who are eligible for reverse total shoulder arthroplasty.
Not a fit: Patients under 60 years of age or those with significant medical comorbidities that prevent surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery protocols for elderly patients after shoulder surgery, enhancing their mobility and quality of life.
How similar studies have performed: Previous studies have shown no significant difference in outcomes with early range of motion versus prolonged immobilization in similar surgical contexts, but this specific approach for fracture cases is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Camden, New Jersey
- Cooper University Hospital — Camden, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Catherine J Fedorka, MD — Cooper Hospital Orthopedic Surgery
- Study coordinator: Pietro M Gentile, BS
- Email: gentile-pietro@CooperHealth.edu
- Phone: 856-968-7079
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.