Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PROCOTYL® C.
- Who it may be relevant to
- Registry conditions: Joint Disease. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device PROCOTYL® C
Hip Arthroplasty
Primary outcome measures
- Component Survivorship [Time frame: 10 years post-operative]
Secondary outcome measures (3)
- To determine the cumulative incidence of component revision at specified intervals out to 10 years follow-up; [Time frame: 2-5 years, 5-7 years, and 10 years]
- To characterize functional scores, as assessed by Oxford Hip. [Time frame: 2-5 years, 5-7 years, and 10 years]
- To characterize functional scores, as assessed by EQ-5D-3L scores. [Time frame: 2-5 years, 5-7 years, and 10 years]
Eligibility criteria
Inclusion criteria
To be included in the study, subjects must meet all of the following criteria:
- Has previously 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;
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Correction of functional deformity
- Subject was implanted with the specified combination of components, namely, any MicroPort Orthopedics or Wright Medical Technology femoral stem and PROCOTYL C Acetabular Components
- Subject is willing and able to complete required study visits or assessments
Previously implanted bilateral subjects can have both THAs (Total Hip Arthroscopy) enrolled in the study provided:
- the specified combination of components were implanted in both,
- all other aspects of the Inclusion/Exclusion Criteria are satisfied,
- enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
- the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrolment of a previously unimplanted hip is not permitted in this study.
Exclusion criteria
Subjects will be excluded if they meet any of the following criteria:
- Subject was skeletally immature (less than 21 years of age) at time of implantation
- Subject has a non-MicroPort or non-Wright Medical Technology component implanted (femoral heads, acetabular shells, acetabular liners) in the enrolled Total Hip Arthroscopy
- Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- Subject is unwilling or unable to sign the Informed Consent document
- Subject has documented substance abuse issues
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- Subject is currently incarcerated or has impending incarceration
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Elbe Kliniken Buxtehude — Buxtehude
Identifiers
NCT: NCT03576573 · 12-LJH-002N