Status:

RECRUITING

The Medacta International SMS Post-Marketing Surveillance Study

Lead Sponsor:

Medacta International SA

Conditions:

Arthrosis

Traumatic Arthritis

Eligibility:

All Genders

18-75 years

Brief Summary

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

Eligibility Criteria

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

Key Trial Info

Start Date :

July 1 2015

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

July 1 2032

Estimated Enrollment :

550 Patients enrolled

Trial Details

Trial ID

NCT02748408

Start Date

July 1 2015

End Date

July 1 2032

Last Update

September 29 2025

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Herz-Jesu Krankenhaus

Vienna, Austria, 1030

2

Istituto Ortopedico Galezzi

Milan, Milan, Italy, 20161

3

Bürgerspital Solothurn

Solothurn, Switzerland, CH-4500

4

The Elective Orthopaedic Centre (EOC)

Epsom, Surrey, United Kingdom, KT18 7EG

The Medacta International SMS Post-Marketing Surveillance Study | DecenTrialz