S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem
NCT ID: NCT05314387
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2022-04-30
2029-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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 without Cementless Finned Short Stem
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.
SMR TT Hybrid Glenoid with Cementless Finned Short Stem
Patients implanted with SMR TT Hybrid Glenoid with Cementless Finned Short Stem
SMR TT Hybrid Glenoid with Cementless Finned Short Stem
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.
Interventions
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SMR TT Hybrid Glenoid without Cementless Finned Short Stem
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.
SMR TT Hybrid Glenoid with Cementless Finned Short Stem
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
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Inclusion Criteria
* 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:
1. Primary osteoarthritis;
2. Secondary osteoarthritis;
3. Post-traumatic arthritis;
4. Rheumatoid arthritis;
5. Avascular necrosis
6. acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
7. cuff tear arthropathy (only in combination with CTA Heads);
8. Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Limacorporate S.p.a
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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S-11
Identifier Type: -
Identifier Source: org_study_id
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