Recruiting

Observational Study

Sponsor:

The Cooper Health System

Code:

NCT06133920

Conditions

Proximal Humeral Fracture

Reverse Total Shoulder Arthroplasty

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Early Range of Motion

Immobilization

Study Details

Brief summary:

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.

Conditions

Proximal Humeral Fracture

Reverse Total Shoulder Arthroplasty

Study ID

NCT06133920

Start date

Feb 24, 2021

Status verified date

Aug, 2024

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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

Interventions

Early Range of Motion

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

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.

Primary outcome measure

  • Early postoperative range of motion [ Time Frame: 2 years ]
  • Postoperative Pain [ Time Frame: 2 years ]
  • Shoulder function [ Time Frame: 2 years ]
  • Postoperative complication [ Time Frame: 2 years ]
  • Tuberosity Healing on Radiographs [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Pietro M Gentile, BS

856-968-7079gentile-pietro@CooperHealth.edu

Locations

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Pietro M Gentile, BA

856-968-7079gentile-pietro@CooperHealth.edu

Catherine J Fedorka, MD

856-968-7262Fedorka-Catherine@CooperHealth.edu

Principal Investigator:

Catherine J Fedorka, MD

More Information

Sponsor

The Cooper Health System

Last update posted

Aug 20, 2024

Last verified

Aug, 2024

Keywords

  • Proximal Humerus Fracture
  • Range of Motion
  • Immobilization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2024-08-20.