PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

NCT ID: NCT02823834

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 121 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-16
• Study Completion Date: 2027-06-30

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 the EU. 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

PROFEMUR® Gladiator Plasma Femoral Stems

Single study group either previously implanted with the following combination of components: PROFEMUR® Gladiator Plasma Femoral Stems, PROCOTYL® L Beaded Acetabular Shells, Polyethylene or Ceramic Liners, and Metal or Ceramic Femoral Heads.

PROFEMUR® Gladiator Plasma Femoral Stems

Intervention Type: DEVICE

THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components

Interventions

PROFEMUR® Gladiator Plasma Femoral Stems

THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components

Intervention Type: DEVICE

Other Intervention Names

Primary hip replacement device

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• 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 skeletally immature (less than 21 years of age) at time of primary THA surgery
• 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

• 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

Principal Investigators

Jose Pimienta

Role: PRINCIPAL_INVESTIGATOR

Elbe Kliniken Buxtehude

Locations

Elbe Kliniken Buxtehude

Buxtehude, , Germany

Countries

Germany

Other Identifiers

12-LJH-002H

Identifier Type: -

Identifier Source: org_study_id