Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems

Terminated

• Conditions: Joint Disease
• Interventions: Device: PROFEMUR® Gladiator HA Coated Modular Femoral Stem

• Registration Number: NCT02314611
• 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 Start: 2014-12
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-11
• Primary Completion: 2019-11
• Study Completion: 2023-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 154

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

Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Investigator Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PROFEMUR® Gladiator HA Coated Stem	PROFEMUR® Gladiator HA Coated Modular Femoral Stem	Single study group previously implanted with a primary PROFEMUR® Gladiator HA Coated Modular Femoral Stem (HA = Hydroxyapatite)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient functional outcomes (hip specific)	5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval	To characterize total functional scores, as assessed by Hip disability and Osteoarthritis Outcome Scores (HOOS)
Patient functional outcomes (quality of life)	5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval	To characterize total functional scores, as assessed by EQ-5D-3L scores

Trial Locations

Locations (1)

Medisch Centrum Latem (outpatient clinic associated with AZ Maria-Middelares); 🇧🇪 Sint-Martens-Latem, Flanders, Belgium