Clinical trial NCT03804853: Rehabilitation Following Reverse Total Shoulder Arthroplasty
Official title: Immediate Accelerated Shoulder Rehabilitation Versus a Standard Protocol Following Reverse Total Shoulder Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Osteoarthritis
Keywords: Rehabilitiation
Reverse total shoulder
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: TRIA Orthopaedic Center
First posted: 2019-01-15
Enrollment: 74
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* \> 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.
* Able and willing to give informed consent.
* Proficient in the English language.

Exclusion Criteria:

In-Clinic:

* 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.
* Additional ipsilateral or contralateral upper limb pathology that requires active treatment (i.e. surgery or brace).
* Inflammatory arthropathy.
* Diagnosed with Rheumatoid arthritis
* Diagnosed with gout.
* Subject is on chronic anticoagulation due to a bleeding disorder or has taken anticoagulants within 10 days prior to surgery.
* Peripheral vascular disease or other vascular disorders that would impair healing.
* Peripheral neuropathy or other neurological disorders that may impair the patient to ambulate.
* Patient is on workers compensation.
* Any condition requiring chemotherapy.
* Active tobacco user or former tobacco user who is not free of using tobacco for 8 weeks.
* Uncontrolled Diabetes Mellitus with an HbA1C \> 7.5%.
* Current drug or alcohol abuse.
* Major medical illness (life expectancy less then 2 years or unacceptably high operative risk)
* Suspicion of cervical radiculopathy or myelopathy.
* Deltoid insufficiency on physical examination.

Intra-operative:

• Iatrogenic glenoid fracture

Post-operative:

* Neurological injury of the upper extremity.
* Complications from Primary Reverse Shoulder Total Arthroplasty (i.e. post-operative infection, bleeding, hardware failure).

Primary outcomes:
measure: American Society for Elbow and Shoulder Score
timeFrame: Pre-operatively
measure: American Society for Elbow and Shoulder Score
timeFrame: 2 weeks
measure: American Society for Elbow and Shoulder Score
timeFrame: 3 months
measure: American Society for Elbow and Shoulder Score
timeFrame: 6 months
measure: American Society for Elbow and Shoulder Score
timeFrame: 1 year
measure: Simple Shoulder Test
timeFrame: Pre-operatively
measure: Simple Shoulder Test
timeFrame: 2 weeks
measure: Simple Shoulder Test
timeFrame: 3 months
measure: Simple Shoulder Test
timeFrame: 6 months
measure: Simple Shoulder Test
timeFrame: 1 year
measure: PROMIS Global 10
timeFrame: Pre-operatively
measure: PROMIS Global 10
timeFrame: 2 weeks
measure: PROMIS Global 10
timeFrame: 3 months
measure: PROMIS Global 10
timeFrame: 6 months
measure: PROMIS Global 10
timeFrame: 1 year
measure: Range of Motion
timeFrame: Pre-operatively, 3 months, 6 months, 1 year post-operatively
measure: Range of Motion
timeFrame: 3 months
measure: Range of Motion
timeFrame: 6 months
measure: Range of Motion
timeFrame: 1 year
Secondary outcomes:
measure: Subscapularis Tear
timeFrame: 1 year
Other outcomes:
measure: Number of PT Visits
timeFrame: 1 Year
Locations:
city: Bloomington
country: United States
facility: TRIA Orthopaedic Center
state: Minnesota
Study officials:
References: