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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285842
First Posted: November 7, 2014
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MicroPort Orthopedics Inc.
  Purpose
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 Intervention
Joint Disease Device: Primary hip resurfacing device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

Resource links provided by NLM:


Further study details as provided by MicroPort Orthopedics Inc.:

Primary Outcome Measures:
  • Component Survivorship [ Time Frame: 10 years post-operative ]
    The primary objective of this study is to estimate survivorship using Kaplan Meier analysis of all components at specified intervals out to 10 years follow-up.


Secondary Outcome Measures:
  • 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

  • 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


Estimated Enrollment: 143
Study Start Date: December 2014
Estimated Study Completion Date: December 2028
Estimated Primary Completion Date: December 2027 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Primary Hip Resurfacings
Single study group previously implanted with CONSERVE® Press-Fit Femoral Components
Device: Primary hip resurfacing device
CONSERVE® Press-Fit Femoral Components

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been previously implanted with CONSERVE® Press-Fit Femoral Components
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285842


Locations
Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
MicroPort Orthopedics Inc.
  More Information

Responsible Party: MicroPort Orthopedics Inc.
ClinicalTrials.gov Identifier: NCT02285842     History of Changes
Other Study ID Numbers: 12-LJH-002F
First Submitted: November 5, 2014
First Posted: November 7, 2014
Last Update Posted: June 20, 2017
Last Verified: June 2017

Keywords provided by MicroPort Orthopedics Inc.:
osteoarthritis
avascular necrosis
ankylosis
protrusio acetabuli
painful hip dysplasia
rheumatoid arthritis
correction of functional deformity
revision procedures

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases