Actively Recruiting

Age: 60Years +
All Genders
ID06133920

Immobilization Versus Early Range of Motion in Reverse Total Arthroplasty in Patients With Proximal Humerus Fractures

Led by The Cooper Health System · Updated on 2024-08-20

40

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the recovery of shoulder movement after reverse total shoulder arthroplasty in older adults with displaced proximal humerus fractures. The study compares two approaches: using a sling for comfort only with early active range of motion allowed versus placing patients in a sling for four weeks with only passive range of motion. This research aims to understand if early movement affects recovery or increases complications, as limited data exists for fracture cases. Participants are randomly assigned to one of two groups after surgery. The immobilization group wears a shoulder abduction sling for four weeks and begins gentle passive motions within set limits. After four weeks, they start active motion but avoid internal rotation until 10 weeks and strengthening until three months. The early range of motion group uses a sling for comfort but can move the arm as tolerated immediately after surgery, starting passive, active assisted, and gentle active motion except internal rotation. Both groups receive formal physical therapy and home exercise programs. Participants will be evaluated at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. Assessments include pain scores, shoulder function, range of motion, complications, and X-rays to check healing. Outcome data will be collected either in person or via email. No extra visits are required beyond standard care. The study will compare long-term recovery and complications between the two treatment approaches.

CONDITIONS

Brief Title

Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patients younger than 60 years of 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate post-operative period

Participants undergo reverse total shoulder arthroplasty surgery for proximal humerus fractures and begin post-operative care according to their assigned group.

1 surgery day visit (in-person)

Post-operative Follow-up

Duration - 2 years

Participants are followed up with regular evaluations to assess pain, shoulder function, range of motion, complications, and radiographs over two years.

Visits at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years (in-person or via email for outcome scores)

Trial Site Locations

Total: 1 location

1

Cooper University Hospital

Camden, New Jersey, United States, 08103

Actively Recruiting

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Research Team

P

Pietro M Gentile, BS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

A randomized single-blinded trial of early rehabilitation versus immobilization after reverse total shoulder arthroplasty.

Mia S Hagen, Sachin Allahabadi, Alan L Zhang...

https://pubmed.ncbi.nlm.nih.gov/31924519

Early Active Motion Versus Sling Immobilization After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial.

David M Sheps, Anelise Silveira, Lauren Beaupre...

https://pubmed.ncbi.nlm.nih.gov/30827428