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

NCT03576573 | Enrolling By Invitation

• 1 other identifier: 12-LJH-002N
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

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

Keywords

Osteoarthritis; Avascular necrosis; Ankylosis; Protrusio acetabuli; Painful hip dysplasia; Rheumatoid arthritis; Correction of functional deformity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To determine the cumulative incidence of component revision at specified intervals out to 10 years follow-up;

  2-5 years, 5-7 years, and 10 years

• To characterize functional scores, as assessed by Oxford Hip.

  2-5 years, 5-7 years, and 10 years

• To characterize functional scores, as assessed by EQ-5D-3L scores.

  2-5 years, 5-7 years, and 10 years

Study Arms (1)

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

Interventions

PROCOTYL® C DEVICE

Hip Arthroplasty

Also known as: Primary Total Hip Device

Primary Total Hip Arthroplasty

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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,

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (1)

Elbe Kliniken Buxtehude

Buxtehude, 21614, Germany

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Osteonecrosis; Ankylosis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 3, 2018
• Study Start: March 27, 2019
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)