The Medacta International SMS Post-Marketing Surveillance Study

Recruiting

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

• Registration Number: NCT02748408
• Lead Sponsor: Medacta International SA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-22
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Primary Completion: 2032-07
• Study Completion: 2032-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
survivorship of the Medacta SMS femoral stem	10-year

Secondary Outcome Measures

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

Trial Locations

Locations (4)

The Elective Orthopaedic Centre (EOC); 🇬🇧 Epsom, Surrey, United Kingdom

Bürgerspital Solothurn; 🇨🇭 Solothurn, Switzerland

Herz-Jesu Krankenhaus; 🇦🇹 Wien, Austria

Istituto Ortopedico Galezzi; 🇮🇹 Milan, Italy