Clinical trial NCT05314387: S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Shoulder Arthritis
Shoulder Osteoarthritis
Arthrosis
Osteoarthritis
Rheumatoid Arthritis
Arthroplasty
Avascular Necrosis
Humeral Fractures
Cuff Tear Arthropathy
Keywords: Shoulder Joint
Shoulder Replacement
Arthritis with rotator cuff tear
Post traumatic fracture sequele
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopedic Clinics

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


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:

  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 (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.

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