SMR Stemless Shoulder Arthroplasty Clinical Study
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Avascular Necrosis of the Head of Humerus
- Post-traumatic; Arthrosis
- Primary Osteoarthritis
- Rheumatoid Arthritis
- Rotator Cuff Tear Arthropathy
- Secondary Osteoarthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The hypothesis at the base of the study is that the SMR stemless system might contribute to ensure good clinical outcomes and an effective stability and might avoid the potential complications associated with a traditional stemmed implant. The aim of this study is to assess clinical, radiographic an...
The hypothesis at the base of the study is that the SMR stemless system might contribute to ensure good clinical outcomes and an effective stability and might avoid the potential complications associated with a traditional stemmed implant. The aim of this study is to assess clinical, radiographic and subjective outcomes after anatomic or reverse shoulder arthroplasty with a SMR stemless prosthesis, define the survivorship of the implant and identify possible risk factors that may lead to failure. This is a post-marketing clinical study, because the study device is registered, CE marked and used according to the intended use. It is an international, multi-centre, prospective case series. The assignment of any patient involved in the study is determined by the aetiology preoperatively evaluated by the Investigator and falls within current practice. The decision to use a specific prosthesis design is decided by the Investigators independently and clearly separated from the decision to include the patient in the study. The evaluation has an internal control because the assessment of post-surgery data is compared to baseline measurements (pre-operative clinical analysis and radiographic analysis at discharge). It is open label. The investigation will be carried out in 3 sites in Europe for a maximum total number of 78 treated patients. Accrual will be competitive until the required recruitment target is met. Equal numbers will be recruited at each of three centres (26 patients per site), but a deviation of 8 participants will be accepted (minimum of 18 and maximum of 34 participants recruited per site).
Tracking Information
- NCT #
- NCT02679352
- Collaborators
- Not Provided
- Investigators
- Not Provided
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