Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems

November 16, 2023 updated by: MicroPort Orthopedics Inc.
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have 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

Detailed Description

Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopedic surgeries performed. The 8th Annual Report from the National Joint Registry of England and Wales reported 95.3% component survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO) currently markets several THA components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA components. The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.

Study Type

Observational

Enrollment (Estimated)

143

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

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H-8L6
        • Ottawa 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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have been previously implanted with a primary PROFEMUR® TL Modular Femoral Stem

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subjects implanted with DYNASTY® BIOFOAM® Acetabular Shells
  • Subjects implanted with a metal-on-metal articulation
  • Subjects implanted with non-MicroPort Orthopedics components (femoral heads, acetabular shells, acetabular liners) in the enrolled THA
  • 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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Total Hip Arthroplasty
Single group previously implanted with the following combination of components: PROFEMUR® TL modular femoral stem, MicroPort Orthopedics acetabular shell, MicroPort Orthopedics polyethylene or ceramic liner, MicroPort Orthopedics metal or ceramic femoral head.
Device: total hip arthroplasty implant
Other Names:
  • PROFEMUR® TL modular femoral stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Component Survivorship
Time Frame: 10 years post-operative
The primary objective of this study is to estimate component survivorship of all components out to 10 years follow-up.
10 years post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient functional outcomes
Time Frame: Screening (First Available), 2-5 years, 5-7 years, and 10 years
The secondary objective is to characterize total functional scores, as assessed by HOOS scores and 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.

Investigators

  • Principal Investigator: Paul Beaule, MD, Ottawa Hospital Research Institute

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)

November 1, 2014

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimated)

September 15, 2014

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-LJH-002I

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.

Clinical Trials on Joint Disease

Clinical Trials on total hip arthroplasty implant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe