The Medacta International SMS Post-Marketing Surveillance Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMedacta International SA

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial population

Individuals suitable for hip replacement using the Medacta SMS femoral stem

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • SMS femoral stem

    Device

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

survivorship of the Medacta SMS femoral stem

Time frame
10-year

Secondary outcomes

1

clinical performance

Harris Hip Score

Time frame
3, 5, 7 and 10 years
2

radiographic performance

presence of radiolucencies

Time frame
3, 5, 7 and 10 years
3

Evaluate the patient satisfaction

Oxford score

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

Evaluate the quality of life

EQ-5D

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.