Clinical trial NCT03576573: Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
Official title: Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Joint Disease
Keywords: Osteoarthritis
Avascular necrosis
Ankylosis
Protrusio acetabuli
Painful hip dysplasia
Rheumatoid arthritis
Correction of functional deformity
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-03
Enrollment: 143
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects previously implanted with any MicroPort Orthopedics or Wright Medical Technology Femoral Stems and PROCOTYL® C Acetabular Components

Brief 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 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:

1. the specified combination of components 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 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

Primary outcomes:
measure: Component Survivorship
timeFrame: 10 years post-operative
Secondary outcomes:
measure: To determine the cumulative incidence of component revision at specified intervals out to 10 years follow-up;
timeFrame: 2-5 years, 5-7 years, and 10 years
measure: To characterize functional scores, as assessed by Oxford Hip.
timeFrame: 2-5 years, 5-7 years, and 10 years
measure: To characterize functional scores, as assessed by EQ-5D-3L scores.
timeFrame: 2-5 years, 5-7 years, and 10 years
Other outcomes:
Locations:
city: Buxtehude
country: Germany
facility: Elbe Kliniken Buxtehude
Study officials:
References: