Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures

NCT ID: NCT06133920

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-24
• Study Completion Date: 2027-02-01

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.

Detailed Description

Reverse shoulder arthroplasty is often used for older patients with displaced proximal humerus fractures in the older patient population. Many surgeons have historically placed patients in a sling for 4-6 weeks after surgery to prevent dislocation or tuberosity displacement. More recently though, surgeons are becoming more lenient with these restrictions as they realize it is very difficult for an elderly patient to be immobilized for 4-6 weeks. There has been one randomized control trial looking at early range of motion versus immobilization for 6 weeks after a regular reverse total shoulder arthroplasty not done for fracture which showed no difference at one year. There have not been any studies to date looking at reverse total shoulder arthroplasty for fracture to see if there is any difference in range of motion at early or later time points and also if there is an increased risk of complications.

Preoperative visit/hospitalization: The patient will be identified as meeting inclusion criteria and the study will be explained to them. Patients will be given a consent form to review with adequate time to review and decide if they wish to participate. If they choose to participate, the patient will sign consent forms witnessed by personnel not associated with the study. Patients will be randomized once consent has been obtained.

The patient will then undergo surgery. Operative data will be collected from their chart including implants used, and intraoperative complications. They will be placed in a sling if they are randomized to the sling group and given instructions on passive range of motion exercises to start postoperative day one. If they are assigned to the early motion group they will be placed in a sling for comfort after surgery but told they can remove it when they feel their pain will allow. They will also be instructed on the same passive range of motion program as the sling group. This is different from the standard of care.

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.

They will undergo their reverse total shoulder arthroplasty for fracture as they will even if they do not agree to participate in the study (normal treatment)

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.

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

Both groups will be evaluated postoperatively at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and two years. At each time point the following will be evaluated.

Visual analog pain score American Shoulder and Elbow Society Scores Range of motion Complications Radiographs will be obtained at these visits

Thereported outcome scores will either be recorded in the office or via email using the surgical outcomes system database that is already approved for use at Cooper via legal for quality outcome measures. The patient will be allowed to determine which method they would prefer and is easier for them.

All of these visits will be the same as patients who choose not to enroll in the study. No additional visits are required for the study. The only differences in treatment will be obtaining the patient outcome scores listed above and the random assignment to one of two treatment groups. The random treatment assignments are as follows; the first group of patients will be placed in a sling for four weeks but with early stretching through physical therapy, and the second group will be allowed to use the sling for comfort only and use their arm as tolerated for motion activities such as dressing and bathing. The second group will also receive physical therapy.

The results of the study will not be shared with the subjects or others unless they ask at the completion of the study at which point final data will be revealed to the subjects that ask.

Conditions

Proximal Humeral Fracture; Reverse Total Shoulder Arthroplasty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Immobilization

Intervention Type: 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.

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

Early Range of Motion

Intervention Type: 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

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cooper Health System

OTHER

Sponsor Role: lead

Responsible Party

Catherine Fedorka MD

Orthopaedic Surgeon, Assistant Professor of Orthopaedic Surgery, Assistant Program Director, Orthopaedic Surgery Residency Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine J Fedorka, MD

Role: PRINCIPAL_INVESTIGATOR

Cooper Hospital Orthopedic Surgery

Locations

Cooper University Hospital

Camden, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pietro M Gentile, BS

Role: CONTACT

gentile-pietro@CooperHealth.edu

856-968-7079

Facility Contacts

Pietro M Gentile, BA

Role: primary

gentile-pietro@CooperHealth.edu

856-968-7079

Catherine J Fedorka, MD

Role: backup

Fedorka-Catherine@CooperHealth.edu

856-968-7262

References

Hagen MS, Allahabadi S, Zhang AL, Feeley BT, Grace T, Ma CB. A randomized single-blinded trial of early rehabilitation versus immobilization after reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2020 Mar;29(3):442-450. doi: 10.1016/j.jse.2019.10.005. Epub 2020 Jan 7.

Reference Type: BACKGROUND

PMID: 31924519 (View on PubMed)

Sheps DM, Silveira A, Beaupre L, Styles-Tripp F, Balyk R, Lalani A, Glasgow R, Bergman J, Bouliane M; Shoulder and Upper Extremity Research Group of Edmonton (SURGE). Early Active Motion Versus Sling Immobilization After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Arthroscopy. 2019 Mar;35(3):749-760.e2. doi: 10.1016/j.arthro.2018.10.139.

Reference Type: BACKGROUND

PMID: 30827428 (View on PubMed)

Agorastides I, Sinopidis C, El Meligy M, Yin Q, Brownson P, Frostick SP. Early versus late mobilization after hemiarthroplasty for proximal humeral fractures. J Shoulder Elbow Surg. 2007 May-Jun;16(3 Suppl):S33-8. doi: 10.1016/j.jse.2006.07.004. Epub 2006 Dec 13.

Reference Type: BACKGROUND

PMID: 17174113 (View on PubMed)

Other Identifiers

IRB #20-533

Identifier Type: -

Identifier Source: org_study_id