PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

Joint Disease Clinical Trial

Official title:

Post Market Clinical Follow-up Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02823834
• Other study ID #: 12-LJH-002H
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases

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