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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02823834
Other study ID # 12-LJH-002H
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 16, 2017
Est. completion date June 2027

Study information

Verified date July 2022
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) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA 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 Active, not recruiting
Enrollment 121
Est. completion date June 2027
Est. primary completion date June 2027
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - 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: - the specified combination of components were implanted in both - all other aspects of the Inclusion/Exclusion Criteria are satisfied - enrollment does not exceed the subject count specified in the Clinical Trial Agreement - the subject agrees to a second Informed Consent document specific to the second THA. Exclusion Criteria: - Subjects implanted with a metal-on-metal articulation - Subjects implanted with non-MPO or non-Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners) at the time of their primary THA in the enrolled THA - 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 or having pending incarceration

Study Design


Related Conditions & MeSH terms


Intervention

Device:
PROFEMUR® Gladiator Plasma Femoral Stems
THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components

Locations

Country Name City State
Germany Elbe Kliniken Buxtehude Buxtehude

Sponsors (1)

Lead Sponsor Collaborator
MicroPort Orthopedics Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Component Survivorship The primary objective of this study is to estimate survivorship analysis 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 Oxford Hip Scores 2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit
Secondary Patient functional outcomes (quality of life) To characterize total functional scores, as assessed by EQ-5D-3L scores 2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit
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