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.