Clinical trial NCT05339815: S-33 SMR Shoulder HP Reverse Glenosphere
Official title: Clinical and Radiographic Outcomes of Reverse Shoulder Arthroplasty Performed With 36-mm CoCrMo vs 40-mm Cross-linked UHMWPE Glenospheres.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthroplasty, Replacement, Shoulder
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2022-04-21
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint is based upon achieving composite clinical success (CCS)
timeFrame: From baseline to FU 24 months
measure: The primary endpoint is based upon achieving composite clinical success (CCS)
timeFrame: From baseline to FU 24 months
measure: The primary endpoint is based upon achieving composite clinical success (CCS)
timeFrame: From baseline to FU 24 months
measure: The primary endpoint is based upon achieving composite clinical success (CCS)
timeFrame: From baseline to FU 24 months
Secondary outcomes:
measure: 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.
timeFrame: From baseline to FU 24 months
measure: 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.
timeFrame: From baseline to FU 24 months
measure: 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.
timeFrame: From baseline to FU 24 months
measure: 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.
timeFrame: From baseline to FU 24 months
measure: Survivorship of the implant (Kaplan-Meier estimate) through 2 years (24 months) of follow-up after surgery
timeFrame: From baseline to FU 24 months
measure: Incidence, type and severity of all Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effect (ADEs), Serious Adverse Device Effects (SADEs)
timeFrame: From baseline to FU 24 months
Other outcomes:
Locations:
city: Wigan
country: United Kingdom
facility: Wrightington, Wigan and Leigh NHS Foundation Trust
Study officials:
References: