Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

Sponsor

MicroPort Orthopedics Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02285842

Collaborator

(none)

143

Enrollment

Location

168

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the 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 MEDDEV 2.12/2 rev 2.

Condition or Disease	Intervention/Treatment	Phase
Joint Disease	Device: Primary hip resurfacing device

Detailed Description

MicroPort Orthopedics Inc. (MPO) currently markets several total hip arthroplasty (THA) and resurfacing components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these components. The objectives of this study are to evaluate component survivorship, total functional outcome scores, and radiographic outcomes of implanted subjects at out to 10 years follow-up.

Study Design

Study Type:

Observational

Actual Enrollment :

143 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

Actual Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Primary Hip Resurfacings Single study group previously implanted with CONSERVE® Press-Fit Femoral Components	Device: Primary hip resurfacing device CONSERVE® Press-Fit Femoral Components

Arm

Intervention/Treatment

Primary Hip Resurfacings

Single study group previously implanted with CONSERVE® Press-Fit Femoral Components

Device: Primary hip resurfacing device

CONSERVE® Press-Fit Femoral Components

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Patient functional outcomes [Screening (First Available), 2-5 years, 5-7 years, and 10 years]
To characterize total functional scores, as assessed by HOOS and EQ-5D-3L scores
Component alignment [Screening (First Available), 2-5 years, 5-7 years, and 10 years]
To evaluate component alignment (neck shaft angle, stem shaft angle, and cup inclination) and the presence of radiolucencies surrounding implanted components

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Has undergone primary hip resurfacing 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

Exclusion Criteria:

Subjects skeletally immature (less than 21 years of age) at time of primary resurfacing 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 have pending incarceration