PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components

Withdrawn

• Conditions: Joint Disease
• Interventions: Device: PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell

• Registration Number: NCT02507258
• 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) and resurfacing components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA and resurfacing 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: 2015-07-21
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-23
• Study Start: 2017-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-06-07
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subject 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

Exclusion Criteria

• Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
• Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA
• 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® Am Femoral Stem	PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell	Single study group previously implanted with a primary PROFEMUR® Am Femoral Stem and PROCOTYL® O HA Coated Acetabular Component

Primary Outcome Measures

Name	Time	Method
Component Survivorship	10 years post-operative	The primary objective of this study is to estimate survivorship using Kaplan Meier analysis of all components at specified intervals out to 10 years follow-up. Measured by capturing date of revision or removal of the device.

Secondary Outcome Measures

Name	Time	Method
Patient functional outcomes (hip specific)	Early (2-5 yrs), Midterm (5-7 yrs), and Long-term (10 yrs + 3 mos) beginning with first available follow-up interval	To characterize total functional scores, as assessed by Oxford Hip and EQ-5D-3L scores

Trial Locations

Locations (1)

Hopital Joseph Ducuing; 🇫🇷 Toulouse, France