Status:
RECRUITING
Rehabilitation Following Reverse Total Shoulder Arthroplasty
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
TRIA Orthopaedic Center
Conditions:
Shoulder Osteoarthritis
Eligibility:
All Genders
55+ years
Phase:
NA
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 hemiarthropla...
Eligibility Criteria
Inclusion
- \> 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
- 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).
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03804853
Start Date
December 12 2018
End Date
December 31 2026
Last Update
June 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
TRIA Orthopaedic Center
Bloomington, Minnesota, United States, 55431