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

Sponsor

MicroPort Orthopedics Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02823834

Collaborator

(none)

121

Enrollment

Location

119.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Joint Disease	Device: PROFEMUR® Gladiator Plasma Femoral Stems

Study Design

Study Type:

Observational

Actual Enrollment :

121 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 16, 2017

Anticipated Primary Completion Date :

Jun 1, 2027

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
PROFEMUR® Gladiator Plasma Femoral Stems Single study group either previously implanted with the following combination of components: PROFEMUR® Gladiator Plasma Femoral Stems, PROCOTYL® L Beaded Acetabular Shells, Polyethylene or Ceramic Liners, and Metal or Ceramic Femoral Heads.	Device: PROFEMUR® Gladiator Plasma Femoral Stems THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components Other Names: Primary hip replacement device

Arm

Intervention/Treatment

PROFEMUR® Gladiator Plasma Femoral Stems

Single study group either previously implanted with the following combination of components: PROFEMUR® Gladiator Plasma Femoral Stems, PROCOTYL® L Beaded Acetabular Shells, Polyethylene or Ceramic Liners, and Metal or Ceramic Femoral Heads.

Device: PROFEMUR® Gladiator Plasma Femoral Stems

THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components

Other Names:

Primary hip replacement device

Outcome Measures

Primary Outcome Measures

Component Survivorship [10 years post-operative]
The primary objective of this study is to estimate survivorship analysis of all components at specified intervals out to 10 years follow-up.

Secondary Outcome Measures

Patient functional outcomes (hip specific) [2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit]
To characterize total functional scores, as assessed by Oxford Hip Scores
Patient functional outcomes (quality of life) [2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit]
To characterize total functional scores, as assessed by EQ-5D-3L scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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