Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

Active, not recruiting

• Conditions: Joint Disease
• Interventions: Device: PROFEMUR® L Revision Femoral Stem

• Registration Number: NCT02314702
• Lead Sponsor: MicroPort Orthopedics Inc.

Brief Summary

MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the 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 MEDDEV 2.12/2 rev 2.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-11
• Study Start: 2015-09-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-13
• Primary Completion: 2026-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Has undergone revision total hip arthroplasty
• Subject is implanted with the specified combination of components
• Subject is willing and able to complete required study visits or assessments

Exclusion Criteria

• Subjects currently enrolled in another clinical study
• Subjects unwilling to sign the Informed Consent document
• Subjects with substance abuse issues
• Subjects who are incarcerated or have pending incarceration

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Revision Total Hip Arthroplasty	PROFEMUR® L Revision Femoral Stem	Single study group previously implanted with a PROFEMUR® L Revision Femoral Stem

Primary Outcome Measures

Name	Time	Method
Number of participants who require a revision	10 years post-operative	The primary objective of this study is to estimate the revision rate of all components at specified intervals out to 10 years follow-up.

Secondary Outcome Measures

Name	Time	Method
Patient functional score on the the Oxford Hip Score instrument	Screening (First Available), 2-5 years, 5-7 years, and 10 years	To characterize patient hip-related health status, as assessed by Oxford Hip Scores
Patient functional score on the EQ-5D-3L instrument	Screening (First Available), 2-5 years, 5-7 years, and 10 years	To characterize patient general health status, as assessed by EQ-5D-3L scores

Trial Locations

Locations (1)

Royal Cornwall Hospital; 🇬🇧 Truro, Cornwall, United Kingdom