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Recruiting

NCT Number: NCT02748408

The Medacta International SMS Post-Marketing Surveillance Study

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

Recruiting

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Key information

Conditions

Arthrosis Arthritis Avascular Necrosis of the Femoral Head Bone Diseases Congenital Abnormalities Congenital Hip Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Developmental Dysplasia of the Hip Femur Head Necrosis Hip Dislocation, Congenital Joint Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Necrosis Osteoarthritis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Polyarthritis Traumatic Arthritis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz-Jesu Krankenhaus, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMS femoral stem

Device

Primary outcomes

  1. survivorship of the Medacta SMS femoral stem

    Time frame: 10-year

Secondary outcomes

  1. clinical performance

    Time frame: 3, 5, 7 and 10 years

    Harris Hip Score

  2. radiographic performance

    Time frame: 3, 5, 7 and 10 years

    presence of radiolucencies

  3. Evaluate the patient satisfaction

    Time frame: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years

    Oxford score

  4. Evaluate the quality of life

    Time frame: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years

    EQ-5D

  5. pattern of bone remodeling

    Time frame: 6 weeks, 6 months, 1 year

    Dual Energy X ray Absorptiometry (DEXA)

  6. stem migration

    Time frame: 6 weeks, 6 months, 1 and 2 years

    Radiostereometric Analysis (RSA)

  7. Adverse events

    Time frame: up to 10 years

    record of adverse event

Study contacts

Contact information is provided by the study sponsor or research team.

Mara Colombo, Eng

CONTACT

[email protected]

0041 91 6966060

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2032
Study completion
2032
First posted
Apr 22, 2016
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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