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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision 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: NCT02314702
Recruitment Status : Enrolling by invitation
First Posted : December 11, 2014
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
MicroPort Orthopedics Inc.

Tracking Information
First Submitted Date December 3, 2014
First Posted Date December 11, 2014
Last Update Posted Date October 21, 2019
Actual Study Start Date September 4, 2015
Estimated Primary Completion Date October 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2014)
Number of participants who require a revision [ Time Frame: 10 years post-operative ]
The primary objective of this study is to estimate the revision rate of all components at specified intervals out to 10 years follow-up.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 8, 2014)
  • Patient functional score on the the Oxford Hip Score instrument [ Time Frame: Screening (First Available), 2-5 years, 5-7 years, and 10 years ]
    To characterize patient hip-related health status, as assessed by Oxford Hip Scores
  • Patient functional score on the EQ-5D-3L instrument [ Time Frame: Screening (First Available), 2-5 years, 5-7 years, and 10 years ]
    To characterize patient general health status, 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® L Revision Femoral Stems
Official Title Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
Brief Summary 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.
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 PROFEMUR® L Revision Femoral Components
Condition Joint Disease
Intervention Device: PROFEMUR® L Revision Femoral Stem
Revision Total Hip Arthroplasty
Other Name: Hip Revision Device
Study Groups/Cohorts Revision Total Hip Arthroplasty
Single study group previously implanted with a PROFEMUR® L Revision Femoral Stem
Intervention: Device: PROFEMUR® L Revision 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 Enrolling by invitation
Estimated Enrollment
 (submitted: December 8, 2014)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2027
Estimated Primary Completion Date October 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Has undergone revision total hip arthroplasty
  • Subject is implanted with the specified combination of components
  • Subject is willing and able to complete required study visits or assessments

Exclusion Criteria:

  • Subjects currently enrolled in another clinical study
  • Subjects unwilling to sign the Informed Consent document
  • Subjects with substance abuse issues
  • Subjects who are incarcerated or have pending incarceration
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 United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02314702
Other Study ID Numbers 12-LJH-002L
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: Gavin Bartlett, MD Royal Cornwall Hospital
PRS Account MicroPort Orthopedics Inc.
Verification Date October 2019