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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 : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
MicroPort Orthopedics Inc.

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.

Condition or disease Intervention/treatment
Joint Disease Device: PROFEMUR® L Revision Femoral Stem

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
Actual Study Start Date : September 4, 2015
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Group/Cohort Intervention/treatment
Revision Total Hip Arthroplasty
Single study group previously implanted with a PROFEMUR® L Revision Femoral Stem
Device: PROFEMUR® L Revision Femoral Stem
Revision Total Hip Arthroplasty
Other Name: Hip Revision Device




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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 PROFEMUR® L Revision Femoral Components
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

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): NCT02314702


Locations
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United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom, TR1 3LJ
Sponsors and Collaborators
MicroPort Orthopedics Inc.
Investigators
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Principal Investigator: Gavin Bartlett, MD Royal Cornwall Hospital

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Responsible Party: MicroPort Orthopedics Inc.
ClinicalTrials.gov Identifier: NCT02314702     History of Changes
Other Study ID Numbers: 12-LJH-002L
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