Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
This study is looking at how long you should keep your arm still after a specific shoulder surgery called reverse total shoulder arthroplasty, which is done for broken upper arm bones (proximal humerus fractures). Researchers want to see if allowing early arm movement right after surgery, with just a sling for comfort, works better than keeping the arm still in a sling for four weeks. They will compare how well your shoulder moves, how much pain you have, and your overall shoulder function two years after surgery. You may be able to join if you are 60 or older, have a displaced proximal humerus fracture, and are having this specific surgery within six weeks of your injury. The study is currently unclear on its recruitment status.
- Study design
- This is an observational study that plans to enroll 40 participants. Participants will be randomly assigned to either the early range of motion group or the immobilization group.
- What's involved
- You will undergo surgery. After surgery, you will either use a sling for comfort and start early movement, or wear a sling for four weeks with limited movement.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your range of motion, pain, and shoulder function will be measured at two years after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
At a glance
Conditions
NCT06133920
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cooper University Hospital
Camden, New Jerseystudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Catherine J Fedorka, MD · PRINCIPAL_INVESTIGATOR · Cooper Hospital Orthopedic Surgery
Who to contact
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Inclusion
Exclusion
What this trial measures
- Early postoperative range of motion2 years
the postoperative range of motion (ROM) will be compared between the 2 groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and two years
- Postoperative Pain2 years
Patients will rate their pain using the VAS pain scale survey. The visual analog scale (VAS) is a pain rating scale first used by Hayes and Patterson in 1921. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). This scale will be administered to both groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The results of these scores will be compared between the two groups at each time point.
- Shoulder function2 years
the postoperative shoulder function assessed by the American Shoulder and Elbow Scale (ASES). This scale includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. The survey will be administered to both groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The results of these scores will be compared between the two groups at each time point.
- Postoperative complication2 years
the 2 year postoperative complications will be recorded and compared between the 2 cohorts.
- Tuberosity Healing on Radiographs2 years
Radiographic outcomes regarding the degree of tuberosity healing will be obtained at each postoperative visit until the 2 year mark and compared between the 2 cohorts After initial imaging, patients will receive subsequent X-rays to monitor tuberosity healing, progression of fracture gap closure with bone formation, and signs of bone resorption. Healing is defined as lack of displacement with consolidation of the fracture and disappearance of previous fracture lines. Displacement will be measured in millimeters compared to position on previous xrays.