Arthroplasty, Replacement, Shoulder
Conditions
Brief summary
Study Design: Single arm, retrospective and prospective, single center, post-market clinical study Purpose:To demonstrate the safety and effectiveness of the SMR Reverse HP Shoulder System device for primary, fracture or revision total shoulder replacement out to 24 months. The eligible study population is the entire population that underwent a reverse shoulder arthroplasty performed with 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres between January 1, 2013 and January 1, 2020 at Wrightington Hospital (UK) in accordance with the indication for use of the product.
Interventions
DEVICESMR shoulder arthroplasty
Data collection of population that underwent a reverse shoulder arthroplasty performed with SMR 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres
Sponsors
Limacorporate S.p.a
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient was treated with the SMR Reverse Shoulder System device (either with 36-mm CoCrMo glenosphere or 40-mm cross-linked UHMWPE glenosphere) between January 1, 2013 and January 1, 2020 as per Instruction for Use 2. Patient was an adult male or female and was 18 years of age or older at the time of surgery 3. Patient received the SMR Reverse Shoulder System for primary, fracture, or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthroplasty 4. The patient's joint was anatomically and structurally suited to receive the selected implants, with a functional deltoid muscle 5. Surgery date is at least 24 months from screening of data 6. Patient has baseline radiographs and Oxford Shoulder Score
Exclusion criteria
1 Patient was treated with the SMR Reverse Shoulder System device (either with 36-mm CoCrMo glenosphere or 40-mm cross-linked UHMWPE glenosphere) between January 1, 2013 and January 1, 2020 out of the Indications for Use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is based upon achieving composite clinical success (CCS) | From baseline to FU 24 months | The primary endpoint is based upon achieving composite clinical success (CCS) from baseline to 24-month follow-up measured as: \- No continuous radiolucent line around the implant Glenoid Component Radiolucency will be graded in accordance with the following definitions: 0\. Absent: No evidence of radiolucency \> 2 mm in width along the bone-implant interface in any zone. 1\. Present: Presence of radiolucency \> 2 mm in width along the bone-implant interface in one or more zones |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the clinical evaluation of the SMR Reverse glenosphere used in real life settings over a period of 2 years (24 months) through PROMs when available and medical evaluation. | From baseline to FU 24 months | Measure Oxford shoulder score Oxford Shoulder Score (OSS) is a 12-item patient-reported PRO specifically designed and developed for assessing outcomes of shoulder surgery. |
| Survivorship of the implant (Kaplan-Meier estimate) through 2 years (24 months) of follow-up after surgery | From baseline to FU 24 months | Kaplan-Meier |
| Incidence, type and severity of all Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effect (ADEs), Serious Adverse Device Effects (SADEs) | From baseline to FU 24 months | Device Related Adverse Events/Serious Adverse Events, device deficiencies, malfunctions and use errors at all follow-up time points |
Countries
United Kingdom
Outcome results
None listed