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SMR Stemless Shoulder Arthroplasty Clinical Study

NCT02679352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-02-24

No results posted yet for this study

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

Interventions

DEVICE

SMR Stemless

Total anatomic or reverse shoulder arthroplasty

Sponsors & Collaborators

  • Limacorporate S.p.a

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2021-12-31
Completion
2024-12-31

Countries

  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02679352 on ClinicalTrials.gov