NCT03576573Enrolling by invitation
Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
Source: ClinicalTrials.gov · Last updated 14 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 143 (estimated)
- First submitted
- 26 Jun 2018
- Start date
- 27 Mar 2019
- Primary completion date
- Dec 2032
- Lead sponsor
- MicroPort Orthopedics Inc.
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT03576573
What you commit to
- Study type: Observational
- Planned participants: 143
- From 27 Mar 2019 to the primary completion date, Dec 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
Age
- Subject was skeletally immature (less than 21 years of age) at time of implantation
Other
- Subjects will be excluded if they meet any of the following criteria:
- 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 is currently incarcerated or has impending incarceration
Who the study is looking for
- 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.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Elbe Kliniken Buxtehude Coordinator of this site? Confirm its status | Buxtehude | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.