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

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.
 
ClinicalTrials.gov Identifier: NCT02314611
Recruitment Status : Active, not recruiting
First Posted : December 11, 2014
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
MicroPort Orthopedics Inc.

Tracking Information
First Submitted Date December 8, 2014
First Posted Date December 11, 2014
Last Update Posted Date November 6, 2020
Actual Study Start Date December 2014
Actual Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 4, 2020)
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.
Original Primary Outcome Measures
 (submitted: December 8, 2014)
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.
Change History
Current Secondary Outcome Measures
 (submitted: December 8, 2014)
  • 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)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems
Official Title Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who have been previously implanted with a PROFEMUR® Gladiator HA Coated Modular Femoral Stem
Condition Joint Disease
Intervention 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
Study Groups/Cohorts PROFEMUR® Gladiator HA Coated Stem
Single study group previously implanted with a primary PROFEMUR® Gladiator HA Coated Modular Femoral Stem (HA = Hydroxyapatite)
Intervention: Device: PROFEMUR® Gladiator HA Coated Modular Femoral Stem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 25, 2020)
154
Original Estimated Enrollment
 (submitted: December 8, 2014)
150
Estimated Study Completion Date December 2027
Actual Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02314611
Other Study ID Numbers 12-LJH-002D
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party MicroPort Orthopedics Inc.
Study Sponsor MicroPort Orthopedics Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Philippe Van Overschelde, MD Algemeen Ziekenhuis Maria-Middelares (Gent, Belgium)
PRS Account MicroPort Orthopedics Inc.
Verification Date November 2020