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

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.

Study Overview

• Status: Terminated
• Conditions: Joint Disease
• Intervention / Treatment: Device: PROFEMUR® Gladiator HA Coated Modular Femoral Stem

• Study Type: Observational
• Enrollment (Actual): 154

Contacts and Locations

Study Locations

• Belgium
  • Flanders
    • Sint-Martens-Latem, Flanders, Belgium, 9830
      • Medisch Centrum Latem (outpatient clinic associated with AZ Maria-Middelares)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been previously implanted with a PROFEMUR® Gladiator HA Coated Modular Femoral Stem

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PROFEMUR® Gladiator HA Coated Stem; Single study group previously implanted with a primary PROFEMUR® Gladiator HA Coated Modular Femoral Stem (HA = Hydroxyapatite)	Device: PROFEMUR® Gladiator HA Coated Modular Femoral Stem; Total Hip Arthroplasty (THA) using PROFEMUR® Gladiator HA Coated Modular Femoral Stem; Other Names: Primary hip replacement device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.
• Investigators: Principal Investigator: Philippe Van Overschelde, MD, Algemeen Ziekenhuis Maria-Middelares (Gent, Belgium)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 8, 2014
• First Posted (Estimated): December 11, 2014

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: osteoarthritis; rheumatoid arthritis; avascular necrosis; correction of functional deformity; ankylosis; protrusio acetabuli; painful hip dysplasia; revision procedures
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 12-LJH-002D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO