Ireland
--:--IST
Active, not recruiting Observational

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Preserve Femoral Stem

NCT03865667 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2019-01-15
Last updated
2023-04-28

Condition(s) studied

Joint Disease

Investigational drug(s) / intervention(s)

PROFEMUR® Preserve Femoral Stem

PROFEMUR® Preserve Femoral Stem: Total Hip Total Hip Arthroscopy

Study summary

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Newly or previously implanted subjects must meet all the following inclusion Criteria: * Has undergone primary Total Hip Arthroscopy for any of the following: * Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;lnflammatory degenerative joint disease such as rheumatoid arthritis; or * Correction of functional deformity; * Subject is implanted with the PROFEMUR® Preserve Femoral Stem(s) and cobalt-chromium Modular Neck; * Subject is willing and able to complete required study visits or assessments through the 10 year postoperative follow-up schedule; * Subject is implanted with WMT or MPO head, cup and liner. Newly or previously implanted bilateral subjects can have both Total Hip Arthroscopy enrolled in the study provided: 1) the specified PROFEMUR® Preserve Femoral Stems and cobalt-chromium Modular Necks were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second Total Hip Arthroscopy. Previously implanted subjects who had undergone revision of any Total Hip Arthroscopy component including the PROFEMUR® Preserve Femoral Stem(s) or, cobalt-chromium Modular Neck will also be eligible to be considered for this study. Exclusion Criteria: Subjects will be excluded if they meet any of the following criteria: * Subjects implanted with non-MicroPort or Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners); * Subjects implanted with a PROFEMUR® Preserve stem assembled to a Titanium Modular Neck; * Subjects skeletally immature (less than 21 years of age) at time of primary Total Hip Arthroscopy surgery; * Subjects have or had an overt infection at the time of implantation; * Subjects have or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation; * Subjects have or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at time of implantation; * Subjects have or had inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable; * Subject has neuropathic joints; * Subject has hepatitis or HIV infection; * Subject has a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing; * Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol; * Subjects unwilling or unable to sign the Informed Consent document; * Subjects with documented substance abuse issues; * Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study; * Subjects who are incarcerated or have pending incarceration.

Primary outcome measure(s)

  • The primary endpoint is to evaluate component survivorship of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck out to 10 years follow-up. — 10 years
    Percentage of hips survived with no revision or replacement at 10-year.

Trial sites (1)

FacilityCityRegionStatus
Dr. Manel Ribas Barcelona Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03865667 on ClinicalTrials.gov ↗ ← All trials in Spain