Rehabilitation Following Reverse Total Shoulder Arthroplasty
ConditionShoulder Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorHealthPartners Institute
About this trial
Reverse total shoulder arthroplasty (RTSA) has been successful in patients with rotator cuff arthropathy, proximal humerus fractures, failed primary total shoulder arthroplasty or failed hemiarthroplasty, and massive irreparable rotator cuff tear. Patients who undergo an RTSA report pain relief and functional range of motion. It has been more than 20 years since the advent of the RTSA construct but an immediate post-operative rehabilitation with active shoulder range of motion has not been prospectively studied in comparison to the traditional post-operative rehabilitation highlighted by Boudreau et al.12 Investigators plan to prospectively follow our patients following RTSA undergoing an immediate active shoulder rehabilitation (IASR) vs traditional rehabilitation in a randomized controlled fashion. Investigators plan to document clinical outcomes, complications and cost effectiveness out to 1 year.
The study will hopefully fulfill the Triple Aim model for HealthPartners by improving the health of the population, improve the experience of each individual, and make healthcare affordable by decreasing the total cost of care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
> 55 years of age.
Candidate for a primary reverse total shoulder arthroplasty.
Capable of completing self-administered questionnaires.
Be willing and able to return for all study-related follow-up procedures.
Disqualifiers
Patients planning on undergoing a Primary Reverse Shoulder Total Arthroplasty due to proximal humeral fracture.
Previous shoulder surgery including previous total shoulder arthroplasty or reverse total shoulder arthroplasty or hemiarthroplasty, or instability repairs
Active bacterial infection of the shoulder.
Any concomitant shoulder procedure.
Trial design
Design model
Single group
Treatments tested in this trial
Rehabilitiation
Other interventionThis study will be a non-blinded randomized controlled outcomes study evaluating outcomes at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively from a primary reverse total shoulder arthroplasty with two different post-operative physical rehabilitation protocols. There will be 2 groups, one undergoing the immediate active shoulder physical therapy protocol consisting of four quadrant stretches and full active motion of the shoulder from post op day 1 in the hospital. The second group will follow the traditional TRIA physical therapy protocol consisting of PT (standard of care) followed by a gradual return to active range of motion of the shoulder beginning by week 6, calling for 18 physical therapy visits. The physical therapy will occur where the patient is most comfortable receiving it.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Immediate Active Shoulder RehabilitationExperimental treatment 1 intervention
Group B: Traditional Should RehabilitationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
American Society for Elbow and Shoulder Score
1\. American Shoulder and Elbow score (ASES) is a scale that measures shoulder pain and function with 11 items, one item for pain and 10 items for function. The score for each subscale is out of 50 (0-50), with a higher score indicating a better outcome. The total score is a sum of both subscales, ranging between 0-100, using the following formula, Total score = ((10 - VAS pain) × 5) + (5/3 × sum of function items).
Time frame
Pre-operatively2
American Society for Elbow and Shoulder Score
1\. American Shoulder and Elbow score (ASES) is a scale that measures shoulder pain and function with 11 items, one item for pain and 10 items for function. The score for each subscale is out of 50 (0-50), with a higher score indicating a better outcome. The total score is a sum of both subscales, ranging between 0-100, using the following formula, Total score = ((10 - VAS pain) × 5) + (5/3 × sum of function items).
Time frame
2 weeks3
American Society for Elbow and Shoulder Score
1\. American Shoulder and Elbow score (ASES) is a scale that measures shoulder pain and function with 11 items, one item for pain and 10 items for function. The score for each subscale is out of 50 (0-50), with a higher score indicating a better outcome. The total score is a sum of both subscales, ranging between 0-100, using the following formula, Total score = ((10 - VAS pain) × 5) + (5/3 × sum of function items).
Time frame
3 months4
American Society for Elbow and Shoulder Score
1\. American Shoulder and Elbow score (ASES) is a scale that measures shoulder pain and function with 11 items, one item for pain and 10 items for function. The score for each subscale is out of 50 (0-50), with a higher score indicating a better outcome. The total score is a sum of both subscales, ranging between 0-100, using the following formula, Total score = ((10 - VAS pain) × 5) + (5/3 × sum of function items).
Time frame
6 monthsSecondary outcomes
1
Subscapularis Tear
Determination if a tear is present.
Time frame
1 yearOther outcomes
1
Number of PT Visits
Count of number of visits.
Time frame
1 YearSponsors and contacts
Click on the lead sponsor to view all of their trials.
HealthPartners Institute
Lead sponsor
TRIA Orthopaedic Center
Collaborator
Source ClinicalTrials.gov