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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems

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ClinicalTrials.gov Identifier: NCT02314611
Recruitment Status : Enrolling by invitation
First Posted : December 11, 2014
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
MicroPort Orthopedics Inc.

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) and resurfacing components marketed in the European Union (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 the medial device directives (MEDDEV) 2.12/2 rev 2.

Condition or disease Intervention/treatment
Joint Disease Device: PROFEMUR® Gladiator HA Coated Modular Femoral Stem

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems
Actual Study Start Date : December 2014
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Group/Cohort Intervention/treatment
PROFEMUR® Gladiator HA Coated Stem
Single study group previously implanted with a primary PROFEMUR® Gladiator HA Coated Modular Femoral Stem (HA = Hydroxyapatite)
Device: PROFEMUR® Gladiator HA Coated Modular Femoral Stem
Total Hip Arthroplasty (THA) using PROFEMUR® Gladiator HA Coated Modular Femoral Stem
Other Name: Primary hip replacement device




Primary Outcome Measures :
  1. 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 :
  1. Patient functional outcomes (hip specific) [ Time Frame: 5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval ]
    To characterize total functional scores, as assessed by Hip disability and Osteoarthritis Outcome Scores (HOOS)

  2. Patient functional outcomes (quality of life) [ Time Frame: 5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval ]
    To characterize total functional scores, as assessed by EQ-5D-3L scores



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been previously implanted with a PROFEMUR® Gladiator HA Coated Modular Femoral Stem
Criteria

Inclusion Criteria:

  • Subject 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: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Investigator Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study.

Exclusion Criteria:

  • 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

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): NCT02314611


Locations
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Belgium
Medisch Centrum Latem (outpatient clinic associated with AZ Maria-Middelares)
Sint-Martens-Latem, Flanders, Belgium, 9830
Sponsors and Collaborators
MicroPort Orthopedics Inc.
Investigators
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Principal Investigator: Philippe Van Overschelde, MD Algemeen Ziekenhuis Maria-Middelares (Gent, Belgium)

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Responsible Party: MicroPort Orthopedics Inc.
ClinicalTrials.gov Identifier: NCT02314611     History of Changes
Other Study ID Numbers: 12-LJH-002D
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
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Joint Diseases
Musculoskeletal Diseases