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Not yet recruiting NCT05314387

S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem

— Observational Shoulder Arthritis Shoulder Osteoarthritis Arthrosis Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SMR TT Hybrid Glenoid without Cementless Finned Short Stem, SMR TT Hybrid Glenoid with Cementless Finned Short Stem.
Who it may be relevant to
Registry conditions: Shoulder Arthritis, Shoulder Osteoarthritis, Arthrosis, Osteoarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicentre, Prospective Clinical Study Analysing Outcomes of Shoulder Arthroplasty With SMR TT Hybrid Glenoid With or Without SMR Cementless Finned Short Stem

Overview

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

Interventions

  • Device 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.
  • Device 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.

Primary outcome measures

  • Proportion of patients reaching a clinical progression from baseline to 24-month follow-up [Time frame: 24 Months]
Secondary outcome measures (11)
  • Measure American Shoulder and Elbow Surgeons Shoulder Score (ASES) [Time frame: Baseline to 24 and 60 Months]
  • Measure Oxford shoulder score [Time frame: Baseline to 24 and 60 Months]
  • Measure Constant Score [Time frame: Baseline to 24 and 60 Months]
  • Measure Simple Shoulder Test [Time frame: Baseline to 24 and 60 Months]
  • Measure Patient Satisfaction [Time frame: Baseline to 24 and 60 Months]
  • Stability of the SMR TT hybrid glenoid component with or without SMR cementless finned short stem [Time frame: Immediately postoperative to 24 Months]
  • System conversion rate, intended as a conversion within the SMR system from anatomic to reverse [Time frame: 24 Months]
  • Failure rate, intended as removal of the SMR TT hybrid glenoid component [Time frame: Immediately postoperative to 24 Months]
  • Failure rate, intended as removal of the SMR cementless finned short stem [Time frame: Immediately postoperative to 24 Months]
  • Incidence of device-related AE/SAE (ADE/SADE) [Time frame: Immediately postoperative to 24 and 60 Months]
  • Survival rate (Kaplan-Meier) [Time frame: 60 Months]

Eligibility criteria

Inclusion Criteria:(Key)

  • 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.

Exclusion Criteria (Key):

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05314387 · S-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗