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NCT Number: NCT02285842

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Joint Disease Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteoarthritis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary hip resurfacing device

Device

CONSERVE® Press-Fit Femoral Components

Primary outcomes

  1. Component Survivorship

    Time frame: 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 outcomes

  1. Patient functional outcomes

    Time frame: 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

  2. Component alignment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

MicroPort Orthopedics Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2027
Study completion
2028
First posted
Nov 7, 2014
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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