Immobilization Versus Early Range of Motion in Reverse Total Arthroplasty in Patients With Proximal Humerus Fractures
Sponsor study identifier
observational
40
1 country
1
Study Start
February 24, 2021
Actual (reported)Primary Completion
February 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 24, 2021
Actual (reported)July 26, 2023
Actual (reported)November 18, 2023
Actual (reported)February 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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
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
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
Cooper University Hospital
Camden, New Jersey, 08103, United States
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.
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.
Catherine J Fedorka, MD
Cooper Hospital Orthopedic Surgery
First Submitted
July 26, 2023
First Posted
November 18, 2023
Study Start
February 24, 2021
Actual (reported)Primary Completion
February 1, 2026
Outcomes Following Delta Xtend Reverse Shoulder System
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 20, 2024
Record last verified: 2024-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: