The Medacta International SMS Post-Marketing Surveillance Study

October 18, 2023 updated by: Medacta International SA

The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study

This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Wien, Austria, 1030
        • Recruiting
        • Herz-Jesu Krankenhaus
        • Contact:
          • Maximilian Walther, Dr
  • Italy
      • Milan, Italy, 20161
        • Recruiting
        • Istituto Ortopedico Galezzi
        • Contact:
          • Giuseppe Peretti, Prof.
  • Switzerland
      • Solothurn, Switzerland, CH-4500
        • Recruiting
        • Bürgerspital Solothurn
        • Contact:
          • Näder Helmy, PD Dr.
  • United Kingdom
    • Surrey
      • Epsom, Surrey, United Kingdom, KT18 7EG
        • Recruiting
        • The Elective Orthopaedic Centre (EOC)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Individuals suitable for hip replacement using the Medacta SMS femoral stem

Description

Inclusion Criteria:

  • Individuals with a severely painful and/or disabling hip joint with osteoarthritis, traumatic arthritis or developmental dysplasia of the hip or avascular necrosis of the femoral head.
  • In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at the time of surgery.
  • Scheduled for a primary total hip replacement.

Exclusion Criteria:

  • Active infection
  • Pregnancy
  • Mental illness where the known condition is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress or complete the 10 year cycle of follow-up appointments and reviews
  • Grossly distorted anatomy (surgeon's discretion)
  • Osteomalacia where uncemented implant fixation is contraindicated
  • Active rheumatoid arthritis.
  • Osteoporosis
  • Metabolic disorders which may impair bone formation where uncemented implant fixation is contraindicated
  • Muscular atrophy or neuromuscular disease
  • Allergy to implant material
  • Any patient who cannot or will not provide informed consent for participation in the study
  • Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survivorship of the Medacta SMS femoral stem
Time Frame: 10-year
10-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical performance
Time Frame: 3, 5, 7 and 10 years
Harris Hip Score
3, 5, 7 and 10 years
radiographic performance
Time Frame: 3, 5, 7 and 10 years
presence of radiolucencies
3, 5, 7 and 10 years
Evaluate the patient satisfaction
Time Frame: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years
Oxford score
6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years
Evaluate the quality of life
Time Frame: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years
EQ-5D
6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years
pattern of bone remodeling
Time Frame: 6 weeks, 6 months, 1 year
Dual Energy X ray Absorptiometry (DEXA)
6 weeks, 6 months, 1 year
stem migration
Time Frame: 6 weeks, 6 months, 1 and 2 years
Radiostereometric Analysis (RSA)
6 weeks, 6 months, 1 and 2 years
Adverse events
Time Frame: up to 10 years
record of adverse event
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medacta International SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Estimated)

July 1, 2032

Study Completion (Estimated)

July 1, 2032

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimated)

April 22, 2016

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P01.019.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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