Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorThe Cooper Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Early Range of Motion
Other interventionThe 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 interventionThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Immobilization Group1 intervention
Group B: Early ROM1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
2 years2
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.
Time frame
2 years3
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.
Time frame
2 years4
Postoperative complication
the 2 year postoperative complications will be recorded and compared between the 2 cohorts.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov