Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures

NCT06133920 | Recruiting

• 1 other identifier: IRB #20-533
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Proximal Humerus Fracture; Range of Motion; Immobilization

Outcome Measures

Primary Outcomes (5)

• Early postoperative range of motion

  the postoperative range of motion (ROM) will be compared between the 2 groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and two years

  2 years

• Postoperative Pain

  Patients will rate their pain using the VAS pain scale survey. The visual analog scale (VAS) is a pain rating scale first used by Hayes and Patterson in 1921. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). This scale will be administered to both groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The results of these scores will be compared between the two groups at each time point.

  2 years

• Shoulder function

  the postoperative shoulder function assessed by the American Shoulder and Elbow Scale (ASES). This scale includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. The survey will be administered to both groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The results of these scores will be compared between the two groups at each time point.

  2 years

• Postoperative complication

  the 2 year postoperative complications will be recorded and compared between the 2 cohorts.

  2 years

• Tuberosity Healing on Radiographs

  Radiographic outcomes regarding the degree of tuberosity healing will be obtained at each postoperative visit until the 2 year mark and compared between the 2 cohorts After initial imaging, patients will receive subsequent X-rays to monitor tuberosity healing, progression of fracture gap closure with bone formation, and signs of bone resorption. Healing is defined as lack of displacement with consolidation of the fracture and disappearance of previous fracture lines. Displacement will be measured in millimeters compared to position on previous xrays.

  2 years

Study Arms (2)

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.

Other: Immobilization

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

Other: Early Range of Motion

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

Early ROM

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.

Immobilization Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 60 years or older who have a displaced proximal humerus fracture that meet surgical criteria for a reverse total shoulder arthroplasty. Patients are not excluded based on sex

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 31924519 BACKGROUND

• 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.

  PMID: 30827428 BACKGROUND

• 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.

  PMID: 17174113 BACKGROUND

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Immobilization

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Catherine J Fedorka, MD

  Cooper Hospital Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro M Gentile, BS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon, Assistant Professor of Orthopaedic Surgery, Assistant Program Director, Orthopaedic Surgery Residency Program

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: November 18, 2023
• Study Start: February 24, 2021
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

US (1)