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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05314387
• Other study ID #: S-11
• Status: Not yet recruiting
• Start date: April 2022
• Est. completion date: April 2029

Study information

• Verified date: March 2022
• Source: Limacorporate S.p.a
• Contact: Laura Sanchez
• Phone: 817-233-1686
• Email: laura.sanchez[@]limacorporate.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2029
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthroplasty
• Arthrosis
• Avascular Necrosis
• Cuff Tear Arthropathy
• Humeral Fractures
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis
• Rotator Cuff Tear Arthropathy
• Shoulder Arthritis
• Shoulder Osteoarthritis

Intervention

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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Survival rate (Kaplan-Meier)		60 Months