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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Joint Disease
• Intervention / Treatment: Device: PROCOTYL® C

• Study Type: Observational
• Enrollment (Estimated): 143

Contacts and Locations

Study Locations

• Germany
  • Buxtehude, Germany, 21614
    • Elbe Kliniken Buxtehude

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: PROCOTYL® C; Hip Arthroplasty; Other Names: Primary Total Hip Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Component Survivorship	The primary endpoint is to evaluate component survivorship of the PROCOTYL® C Acetabular Components out to 10 years follow-up. Percentage of hips survived with no revision or replacement at 10-year.	10 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the cumulative incidence of component revision at specified intervals out to 10 years follow-up;	Percentage of hips that were revised or replaced at each of the intervals namely for Early (2-5 years), midterm (5-7 Year), and long-term (10-year) evaluation.	2-5 years, 5-7 years, and 10 years
To characterize functional scores, as assessed by Oxford Hip.	The study will be reporting the final Oxford Hip score, which is a summary over 12 items. Each of these items is 5-level Likert scale such as from 'not at all' to 'totally'.	2-5 years, 5-7 years, and 10 years
To characterize functional scores, as assessed by EQ-5D-3L scores.	EQ-5D-3L data will be summarized over 5 domains, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain has 3 levels: no problems, some problems, and extreme problems.	2-5 years, 5-7 years, and 10 years

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 3, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Rheumatoid arthritis; Avascular necrosis; Correction of functional deformity; Ankylosis; Protrusio acetabuli; Painful hip dysplasia
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 12-LJH-002N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No