SMR Stemless Shoulder Arthroplasty Clinical Study

NCT02679352 | Completed

• 1 other identifier: S-08
• Study Type: interventional
• Target: 78
• Locations: 3 countries
• Sites: 4

Brief Summary

Shoulder arthroplasty is a reliable procedure for the treatment of severe shoulder joint diseases to relieve pain and restore shoulder function. Shoulder implants commonly used are characterised by a humeral stem and complications related to the stem are not infrequent. These include: bone stock loss, intraoperative and postoperative break around the implant, malpositioning of the humeral component and difficult eradication of infections inside the bone around the implant. With the aim of reducing stem-related complications, a novel prosthesis characterised by a stem-less design has been developed. The objective of this study is therefore to explore how well people recover after shoulder replacement with this novel stem-less shoulder prosthesis. This will be assessed over 5 years in three different countries in Europe using patient completed questionnaires and clinical and radiographic assessments.

Conditions

Primary Osteoarthritis; Secondary Osteoarthritis; Post-traumatic; Arthrosis; Rheumatoid Arthritis; Avascular Necrosis of the Head of Humerus; Rotator Cuff Tear Arthropathy

Outcome Measures

Primary Outcomes (1)

• Efficacy as assessed by proportion of patients reaching a clinical progression measured as Constant score change

  Constant score change of greater than 10 points

  24 months

Study Arms (1)

SMR stemless

EXPERIMENTAL

Patients requiring a primary anatomic or reverse shoulder arthroplasty, due to symptomatic painful degenerative joint diseases with good bone stock

Device: SMR Stemless

Interventions

SMR Stemless DEVICE

Total anatomic or reverse shoulder arthroplasty

SMR stemless

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders;
• Age ≥ 18 years old;
• Full skeletal maturity;
• Life expectancy over 5 years;
• Patient is requiring primary unilateral or bilateral anatomic or reverse arthroplasty based on physical examination and medical history;
• Good bone quality evaluated by the Investigator on the basis of a risk factors analysis (included MORES/SCORE questionnaires) and the intraoperative evaluation;
• A diagnosis in the target shoulder of one or more of the following:
• Primary osteoarthritis;
• Secondary osteoarthritis;
• Post-traumatic arthritis;
• Rheumatoid arthritis;
• Avascular necrosis of the humeral head (radiologically less than 20%);
• Cuff tear arthropathy.
• Patient submitted to previous conservative non-surgical treatments;
• Patient is willing and able to complete scheduled follow-up evaluations as described in the Patient Information Sheet;

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (4)

St. Anna Hospital

Herne, 44649, Germany

Location

Spaarne Hospital

Hoofddorp, 2134 TM, Netherlands

Location

Zorgsaam Zorggroep Ziekhenhuis Terneuzen

Terneuzen, 4535, Netherlands

Location

North Bristol NHS

Bristol, BS10 5NB, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Chondrocalcinosis; Crystal Arthropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 10, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); NL (2); DE (1)