S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem
A Multicentre, Prospective Clinical Study Analysing Outcomes of Shoulder Arthroplasty With SMR TT Hybrid Glenoid With or Without SMR Cementless Finned Short Stem
1 other identifier
observational
100
0 countries
N/A
Brief Summary
Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2022
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
April 6, 2022
March 1, 2022
5 years
March 18, 2022
March 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients reaching a clinical progression from baseline to 24-month follow-up
The primary endpoint consists of the proportion of patients reaching a clinical progression from baseline to 24-month follow-up measured as: * Constant score improvement of greater than 10; * Adjusted Constant score greater than or equal to 54.
24 Months
Secondary Outcomes (11)
Measure American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Baseline to 24 and 60 Months
Measure Oxford shoulder score
Baseline to 24 and 60 Months
Measure Constant Score
Baseline to 24 and 60 Months
Measure Simple Shoulder Test
Baseline to 24 and 60 Months
Measure Patient Satisfaction
Baseline to 24 and 60 Months
- +6 more secondary outcomes
Study Arms (2)
SMR TT Hybrid Glenoid without Cementless Finned Short Stem
Patients implanted with SMR TT Hybrid Glenoid without Cementless Finned Short Stem
SMR TT Hybrid Glenoid with Cementless Finned Short Stem
Patients implanted with SMR TT Hybrid Glenoid with Cementless Finned Short Stem
Interventions
The subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation.
The subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation. The fins are intended to enhance press-fit fixation. The same proximal morse taper is used for coupling to the same humeral bodies in the SMR Shoulder System. The SMR finned short stem is intended for cementless fixation.
Eligibility Criteria
Orthopedic Clinics
You may qualify if:
- Both genders;
- Age ≥ 18 years old;
- Full skeletal maturity;
- Life expectancy over 5 years;
- Patient is requiring primary unilateral arthroplasty based on physical examination and medical history;
- Good bone quality evaluated by the Investigator and the intraoperative evaluation;
- A diagnosis in the target shoulder of one or more of the S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem Version Sep 2021 2.0 Confidential Page11 following:
- Primary osteoarthritis;
- Secondary osteoarthritis;
- Post-traumatic arthritis;
- Rheumatoid arthritis;
- Avascular necrosis
- acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
- cuff tear arthropathy (only in combination with CTA Heads);
- Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification.
You may not qualify if:
- Patient requiring revision shoulder arthroplasty;
- Osteoporosis with a history of non-traumatic fractures;
- Steroid injections within the previous 3 months;
- Contralateral shoulder replacement within the previous 3 months;
- Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator;
- Significant neurological or musculoskeletal disorders that may compromise functional recovery;
- Not recovered axillary nerve palsy;
- Non functioning deltoid muscle;
- Known or suspicious hypersensitivity to the metal or other components and materials of the implant;
- Participation in any experimental drug/device study within the 6 months prior to the preoperative visit;
- Women of childbearing potential who are pregnant, nursing, or planning to become pregnant.
- These are key eligibility criteria, other eligibility criteria apply.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2022
First Posted
April 6, 2022
Study Start
April 1, 2022
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2029
Last Updated
April 6, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share