None listed
Conditions
Brief summary
This is a study involving multiple hospitals in Australia and is collecting data prospectively. Its aim is to assess patients presenting glenohumeral arthritis who are undergoing a primary anatomical total shoulder arthroplasty procedure. The performance of the Affinis Glenoid vitamys uncemented in anatomical total shoulder arthroplasty is assessed through: • Survivorship (rates of revision) • Patient mortality rates, • Range of Motion analysis, • Complications • Evaluation of x rays • Patient reported outcome Measurements (PROMs)
Interventions
This multi-centre prospective registry-nested study is designed to assess patients presenting with glenohumeral arthritis who are undergoing a primary anatomical total shoulder arthroplasty procedure.
The primary objective is to determine glenoid implant survival at 2, 5 and 10 years post-operatively utilising the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) data rates of revision.
Patient are involved in the study to answer online Patient Reported Outcome Me
This multi-centre prospective registry-nested study is designed to assess patients presenting with glenohumeral arthritis who are undergoing a primary anatomical total shoulder arthroplasty procedure. The primary objective is to determine glenoid implant survival at 2, 5 and 10 years post-operatively utilising the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) data rates of revision. Patient are involved in the study to answer online Patient Reported Outcome Measures (PROMs) preoperatively and at follow-up visits. All other procedures are performed as per standard of care and data is collected through AOANJRR. Survivorship of the implant is observed in terms of adverse event, complication of the implants, reason of revision, radiographic data and mortality. The following online questionnaires are collected: American Shoulder and Elbow Surgeons (ASES): 3-5 minutes to complete Oxford Society Score (OSS): 2-5 minutes to complete EQ-5D-5L: around 2-5 minutes to complete VAS pain scale: 1 minute to complete .
Sponsors
Mathys Ltd Bettlach
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Primary diagnosis of glenohumeral arthritis undergoing an anatomical total shoulder ar-throplasty. 2. Adults aged between 18 and 80 years at the time of surgery. 3. Ability to give informed consent. 4. Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period.
Exclusion criteria
1. Rotator Cuff tear - CT soft tissue sagittal slice demonstrating POSITIVE Tangent sign 2. Glenoid Morphology (derived from patient CT scan and assessed by a standard digital templating software): - Parameters assessed AFTER planned reaming: i. > 0° anteversion OR >10° retroversion of the glenoid ii. >15° superior inclination iii. Less than 90% implant to glenoid face contact on final plan 3. Inflammatory arthropathy that has been, or is currently managed with disease-modifying antirheumatic drugs (DMARDs), excluding nonsteroidal anti-inflammatory drugs (NSAIDs) 4. Presence of malignant tumours, patients who had chemotherapy treatment within 6 months before surgery 5. Chronic Corticosteroid use 6. Unable to provide informed consent 7. Unable to participate in post-operative rehabilitation protocol 8. Unable to attend follow up (geographical / social situation) 9. Patients with a history of active infection 10. Pregnant or breast-feeding women 11. Revision procedures of the shoulder of interest
Outcome results
None listed