Multicentric, randomised, prospective trial to assess the efficacy and safety of a novel stemless reverse shoulder system
- Conditions
- Clinical and radiological indication for reverse total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis and/or cuff tear arthropathy/insufficient rotator cuff
- Registration Number
- DRKS00034598
- Lead Sponsor
- Medacta Germany GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 124
•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
•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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oxford Shoulder Score (12 months)
- Secondary Outcome Measures
Name Time Method Implant failure according to the Kaplan Meier curve (6 weeks and 6, 12, 24 months)<br>Range of Motion (6 weeks and 6, 12, 24 months)<br>Radiolucencies, Migration, Osteolysis, Subsidence (6 weeks and 6, 12, 24 months)<br>Complications and Adverse Events (6 weeks and 6, 12, 24 months)<br>Oxford Shoulder Score (6 weeks and 6, 12, 24 months)