Follow-up study of PROCOTYL C hip implants in people with joint disease
Follows adults with joint disease who received a PROCOTYL C hip implant over time.
Plain-language title generated from the registry record
Registry title: Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
Key facts
- Where
- Buxtehude, GermanySee the site
Where in Germany
- Elbe Kliniken BuxtehudeBuxtehude, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- MicroPort Orthopedics Inc.
- Trial code
- NCT03576573
- Record updated
- 14 November 2023
- Original description
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.Read full original descriptionShow less
Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
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.
Inclusion: 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: Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study; Subject was skeletally immature (less than 21 years of age) at time of implantation; 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.