40 Participants Needed

Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures

PM
Overseen ByPietro M Gentile, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cooper Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

CJ

Catherine J Fedorka, MD

Principal Investigator

Cooper Hospital Orthopedic Surgery

Eligibility Criteria

Inclusion Criteria

People who are 60 years or older and have a broken upper arm near the shoulder.
You are eligible for a specific type of shoulder surgery called reverse total shoulder arthroplasty.
You had surgery within 6 weeks of getting hurt.

Treatment Details

Participant Groups
2Treatment groups
Experimental Treatment
Group I: Immobilization GroupExperimental Treatment1 Intervention
The immobilization group will be placed in a shoulder abduction sling immediately after surgery for four weeks. They will be allowed to start gentle passive range of motion with forward flexion to 120 degrees, abduction to 90 degrees, and external rotation to 30 degrees. They will receive a home exercise program and formal physical therapy with these limits. When they come out of the sling at four weeks they will start active range of motion and active assisted range of motion. They cannot internally rotate until 10 weeks after surgery. No formal strengthening until 3 months after surgery.
Group II: Early ROMExperimental Treatment1 Intervention
The early range of motion group will be given a sling for comfort after their surgery. They will be told they can use their arm as tolerated and can remove the sling when comfortable immediately after surgery. They will be allowed to start passive range of motion, active assisted range of motion, and gentle active range of motion with therapy as tolerated with the exception of no internal rotation. They will also not be allowed to strengthen until 12 weeks after surgery. They will get formal physical therapy and be given a home exercise program as well that will be directed by their physical therapist

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cooper Health System

Lead Sponsor

Trials
82
Recruited
35,600+