Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures

Part of paid clinical trials in Camden, New Jersey.

Sponsor
The Cooper Health System
Study ID
NCT06133920
Status
Recruiting
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Conditions

  • Proximal Humeral Fracture
  • Reverse Total Shoulder Arthroplasty

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Early Range of Motion — OTHER
    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
  • Immobilization — OTHER
    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.

Study Details

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.

Key Dates

Start date
Feb 24, 2021
Status verified
Aug 2024
Primary completion
Feb 1, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Immobilization Group
    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.
  • Arm: Early ROM
    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

Primary Outcome Measure

Early postoperative range of motion [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cooper University HospitalCamdenNew Jersey08103
Pietro M Gentile, BA
[email protected]
856-968-7079
Catherine J Fedorka, MD
[email protected]
856-968-7262
Catherine J Fedorka, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Camden, NJ

By research site
Cooper University Hospital· Camden, NJ

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