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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02314611
Other study ID # 12-LJH-002D
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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