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

Active, not recruiting

• Conditions: Joint Disease
• Interventions: Device: PROFEMUR® Gladiator Plasma Femoral Stems

• Registration Number: NCT02823834
• Lead Sponsor: MicroPort Orthopedics Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-06
• Study Start: 2017-06-16
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 121

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
• all other aspects of the Inclusion/Exclusion Criteria are satisfied
• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PROFEMUR® Gladiator Plasma Femoral Stems	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.

Primary Outcome Measures

Name	Time	Method
Component Survivorship	10 years post-operative	The primary objective of this study is to estimate survivorship analysis of all components at specified intervals out to 10 years follow-up.

Secondary Outcome Measures

Name	Time	Method
Patient functional outcomes (hip specific)	2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit	To characterize total functional scores, as assessed by Oxford Hip Scores
Patient functional outcomes (quality of life)	2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit	To characterize total functional scores, as assessed by EQ-5D-3L scores

Trial Locations

Locations (1)

Elbe Kliniken Buxtehude; 🇩🇪 Buxtehude, Germany