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

Joint Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02314611
• Other study ID #: 12-LJH-002D
• Status: Terminated
• Start date: December 2014
• Est. completion date: November 2023

Study information

• Verified date: January 2024
• Source: MicroPort Orthopedics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 154
• Est. completion date: November 2023
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases

Intervention

Device:
• PROFEMUR® Gladiator HA Coated Modular Femoral Stem
Total Hip Arthroplasty (THA) using PROFEMUR® Gladiator HA Coated Modular Femoral Stem

Locations

Country	Name	City	State
Belgium	Medisch Centrum Latem (outpatient clinic associated with AZ Maria-Middelares)	Sint-Martens-Latem	Flanders

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort Orthopedics Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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