Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components

NCT ID: NCT03576573

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 143 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-27
• Study Completion Date: 2032-12-31

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.

Conditions

Joint Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Primary Total Hip Arthroplasty

Single arm study of subjects previously implanted with any MicroPort Orthopedics or Wright Medical Technology femoral stems and PROCOTYL® C Acetabular Components

PROCOTYL® C

Intervention Type: DEVICE

Hip Arthroplasty

Interventions

PROCOTYL® C

Hip Arthroplasty

Intervention Type: DEVICE

Other Intervention Names

Primary Total Hip Device

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,

Exclusion Criteria

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.

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroPort Orthopedics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Elbe Kliniken Buxtehude

Buxtehude, , Germany

Countries

Germany

Other Identifiers

12-LJH-002N

Identifier Type: -

Identifier Source: org_study_id