Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

October 12, 2022 updated by: MicroPort Orthopedics Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have been previously implanted with PROFEMUR® L Revision Femoral Components

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Hip Revision Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Screening (First Available), 2-5 years, 5-7 years, and 10 years
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
Screening (First Available), 2-5 years, 5-7 years, and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroPort Orthopedics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2015

Primary Completion (Anticipated)

October 1, 2026

Study Completion (Anticipated)

October 1, 2027

Study Registration Dates

First Submitted

December 3, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 11, 2014

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-LJH-002L

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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