The Medacta International SMS Post-Marketing Surveillance Study

NCT02748408 | Recruiting

• 1 other identifier: P01.019.01
• Study Type: observational
• Target: 550
• Locations: 4 countries
• Sites: 4

Brief Summary

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

Conditions

Arthrosis; Traumatic Arthritis; Rheumatoid Polyarthritis; Congenital Hip Dysplasia; Avascular Necrosis of the Femoral Head

Outcome Measures

Primary Outcomes (1)

• survivorship of the Medacta SMS femoral stem

  10-year

Secondary Outcomes (7)

• clinical performance

  3, 5, 7 and 10 years

• radiographic performance

  3, 5, 7 and 10 years

• Evaluate the patient satisfaction

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

• Evaluate the quality of life

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

• pattern of bone remodeling

  6 weeks, 6 months, 1 year

Interventions

SMS femoral stem DEVICE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals suitable for hip replacement using the Medacta SMS femoral stem

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (4)

Herz-Jesu Krankenhaus

Vienna, 1030, Austria

RECRUITING

Istituto Ortopedico Galezzi

Milan, Milan, 20161, Italy

RECRUITING

Bürgerspital Solothurn

Solothurn, CH-4500, Switzerland

RECRUITING

The Elective Orthopaedic Centre (EOC)

Epsom, Surrey, KT18 7EG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Hip Dislocation, Congenital; Femur Head Necrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mara Colombo, Eng

CONTACT

0041 91 6966060; colombo@medacta.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 22, 2016
• Study Start: July 1, 2015
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): July 1, 2032
• Last Updated: September 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); CH (1); GB (1); IT (1)