NCT02823834Active, not recruiting
PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components
Post Market Clinical Follow-up Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components
Source: ClinicalTrials.gov · Last updated 8 Jul 2022
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 the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 121 (actual)
- First submitted
- 1 Jul 2016
- Start date
- Jun 2017
- Primary completion date
- Jun 2027
- Lead sponsor
- MicroPort Orthopedics Inc.
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT02823834
What you commit to
- Study type: Observational
- Participants enrolled: 121
- From Jun 2017 to the primary completion date, Jun 2027
- 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.
Age
- Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
Other
- Subjects implanted with a metal-on-metal articulation
- Subjects implanted with non-MPO or non-Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners) at the time of their primary THA in the enrolled THA
- Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
- Subjects unwilling to sign the Informed Consent document
- Subjects with substance abuse issues
- Subjects who are incarcerated or having pending incarceration
Who the study is looking for
- Has undergone primary THA 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; or
- Correction of functional deformity
- Subject is implanted with the specified combination of components
- Subject is willing and able to complete required study visits or assessments
- Previously implanted bilateral subjects can have both THAs 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
- the subject agrees to a second Informed Consent document specific to the second THA.
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.