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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Joint Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 143

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been previously implanted with CONSERVE® Press-Fit Femoral Components

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.
• Investigators: Principal Investigator: Paul Beaule, MD, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: November 5, 2014
• First Posted (Estimated): November 7, 2014

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: osteoarthritis; rheumatoid arthritis; avascular necrosis; correction of functional deformity; ankylosis; protrusio acetabuli; painful hip dysplasia; revision procedures
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 12-LJH-002F