Clinical and radiological indication for reverse total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis and/or cuff tear arthropathy/insufficient rotator cuff
Conditions
Interventions
Group 1: Reverse Shoulder Arthroplasty surgery with Stemless Reverse Medacta Shoulder System (single surgical intervention, followed by standard postoperative care)
Group 2: Reverse Shoulder Arthropla
Sponsors
Medacta Germany GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Conservative therapy options have been exhausted • Clinical and radiological (Rx or Ct or MRT) indication for reverse total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis and/or cuff tear arthropathy/insufficient rotator cuff • Functional deltoid muscle • Willingness and ability to comply with study protocol
Exclusion criteria
Exclusion criteria: • Clinical and radiological (Rx or Ct or MRT) indication for anatomic total shoulder replacement • Medical condition or balance impairment that could lead to falls • Lack of sufficient-quality bone to seat and support implant • Patients with metaphyseal cysts, osteopenia, osteoporosis, or other metabolic bone diseases, or in cases with fractures in the metaphyseal area that disturb adequate primary implant stability and secondary fixation • Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcome • Parkinson • Hemiplegia on the affected side • Arm plexus affection on the affected side • Weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation • Active metastatic or neoplastic disease at the shoulder joint • Chemotherapy treatment/radiotherapy within 6 mo before surgery • >5 mg/day of corticosteroids, excluding inhalers, within 3 years before surgery • Pregnancy or plan to become pregnant during study period • Inability to understand study or a history of noncompliance with medical advice • Current enrolment in any clinical research study that might interfere with this study • Known metal allergies or sensitivity. • Previous or actual infection at or near the site of implantation. • Previous or actual distant or systemic infection • Previous inclusion of the patient in the current study because of the controlateral shoulder • Lack of sufficient-quality bone to seat and support the metaphyseal humeral implant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxford Shoulder Score (12 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Implant failure according to the Kaplan Meier curve (6 weeks and 6, 12, 24 months) Range of Motion (6 weeks and 6, 12, 24 months) Radiolucencies, Migration, Osteolysis, Subsidence (6 weeks and 6, 12, 24 months) Complications and Adverse Events (6 weeks and 6, 12, 24 months) Oxford Shoulder Score (6 weeks and 6, 12, 24 months) | — |
Countries
Germany
Contacts
Public ContactMarco Viganò
Medacta International SA
Outcome results
None listed