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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Arthroplasty; Avascular Necrosis; Arthrosis; Humeral Fractures; Shoulder Osteoarthritis; Shoulder Arthritis; Cuff Tear Arthropathy
• Intervention / Treatment: Device: SMR TT Hybrid Glenoid without Cementless Finned Short Stem; Device: SMR TT Hybrid Glenoid with Cementless Finned Short Stem

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Laura Sanchez; Phone Number: 817-233-1686; Email: laura.sanchez@limacorporate.com
• Study Contact Backup: Name: Ryan Bacchus; Phone Number: 817-233-1686; Email: ryan.bacchus@limacorporate.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Orthopedic Clinics

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SMR TT Hybrid Glenoid without Cementless Finned Short Stem; Patients implanted with SMR TT Hybrid Glenoid without Cementless Finned Short Stem	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.
SMR TT Hybrid Glenoid with Cementless Finned Short Stem; Patients implanted with SMR TT Hybrid Glenoid with Cementless Finned Short Stem	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure American Shoulder and Elbow Surgeons Shoulder Score (ASES)	The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.	Baseline to 24 and 60 Months
Measure Oxford shoulder score	Oxford Shoulder Score (OSS) is a 12-item patient-reported PRO specifically designed and developed for assessing outcomes of shoulder surgery.	Baseline to 24 and 60 Months
Measure Constant Score	The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The higher the score, the higher the quality of the function.	Baseline to 24 and 60 Months
Measure Simple Shoulder Test	Simple Shoulder Test (SST) is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. The answers to these questions provides a standardized way of recording the function of a shoulder before and after treatment. The difference between the shoulder function before treatment and after the recovery period is the effectiveness of the treatment.	Baseline to 24 and 60 Months
Measure Patient Satisfaction	The satisfaction of the patients with regard to the effectiveness of the prosthetic treatment is graded on a scale from 1 to 5	Baseline to 24 and 60 Months
Stability of the SMR TT hybrid glenoid component with or without SMR cementless finned short stem	Rate of symptomatic radiolucent lines, loosening and subsidence ≥2 mm	Immediately postoperative to 24 Months
System conversion rate, intended as a conversion within the SMR system from anatomic to reverse	The SMR shoulder system is a modular system and in case of evolution of the pathology it may be easily converted from one configuration to another.	24 Months
Failure rate, intended as removal of the SMR TT hybrid glenoid component	A removal of the glenoid component is intended as a revision and a failure of the implant.	Immediately postoperative to 24 Months
Failure rate, intended as removal of the SMR cementless finned short stem	A removal of the stem component is intended as a revision and a failure of the implant.	Immediately postoperative to 24 Months
Incidence of device-related AE/SAE (ADE/SADE)	Device Related Adverse Events/Serious Adverse Events, device deficiencies, malfunctions and use errors at all follow-up time points	Immediately postoperative to 24 and 60 Months
Survival rate (Kaplan-Meier)		60 Months

Collaborators and Investigators

• Sponsor: Limacorporate S.p.a

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): April 1, 2027
• Study Completion (Anticipated): April 1, 2029

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Shoulder Joint; Shoulder Replacement; Arthritis with rotator cuff tear; Post traumatic fracture sequele
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arm Injuries; Crystal Arthropathies; Chondrocalcinosis; Arthritis; Osteoarthritis; Necrosis; Humeral Fractures; Rotator Cuff Tear Arthropathy
• Other Study ID Numbers: S-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No