The Medacta International SMS Post-Marketing Surveillance Study

Traumatic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02748408
• Other study ID #: P01.019.01
• Status: Recruiting
• Start date: July 2015
• Est. completion date: July 2032

Study information

• Verified date: October 2023
• Source: Medacta International SA
• Contact: Mara Colombo, Eng
• Phone: 0041 91 6966060
• Email: colombo[@]medacta.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: July 2032
• Est. primary completion date: July 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthrosis
• Avascular Necrosis of the Femoral Head
• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Osteoarthritis
• Rheumatoid Polyarthritis
• Traumatic Arthritis

Intervention

Device:
• SMS femoral stem

Locations

Country	Name	City	State
Austria	Herz-Jesu Krankenhaus	Wien
Italy	Istituto Ortopedico Galezzi	Milan
Switzerland	Bürgerspital Solothurn	Solothurn
United Kingdom	The Elective Orthopaedic Centre (EOC)	Epsom	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Countries where clinical trial is conducted

Austria,  Italy,  Switzerland,  United Kingdom, 

Outcome

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