NCT02314611

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

4.9 years

First QC Date

December 8, 2014

Last Update Submit

January 5, 2024

Conditions

Joint Disease

Keywords

osteoarthritisavascular necrosisankylosisprotrusio acetabulipainful hip dysplasiarheumatoid arthritiscorrection of functional deformityrevision procedures

Outcome Measures

Primary Outcomes (1)

  • Component Survivorship

    The primary objective of this study is to estimate survivorship of all components at specified intervals out to 10 years follow-up.

    10 years post-operative

Secondary Outcomes (2)

  • Patient functional outcomes (hip specific)

    5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval

  • Patient functional outcomes (quality of life)

    5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval

Study Arms (1)

PROFEMUR® Gladiator HA Coated Stem

Single study group previously implanted with a primary PROFEMUR® Gladiator HA Coated Modular Femoral Stem (HA = Hydroxyapatite)

Device: PROFEMUR® Gladiator HA Coated Modular Femoral Stem

Interventions

PROFEMUR® Gladiator HA Coated Modular Femoral StemDEVICE

Total Hip Arthroplasty (THA) using PROFEMUR® Gladiator HA Coated Modular Femoral Stem

Also known as: Primary hip replacement device
PROFEMUR® Gladiator HA Coated Stem

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been previously implanted with a PROFEMUR® Gladiator HA Coated Modular Femoral Stem

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medisch Centrum Latem (outpatient clinic associated with AZ Maria-Middelares)

Sint-Martens-Latem, Flanders, 9830, Belgium

Location

MeSH Terms

Conditions

Joint DiseasesOsteoarthritisOsteonecrosisAnkylosisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesArthritisRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Philippe Van Overschelde, MD

    Algemeen Ziekenhuis Maria-Middelares (Gent, Belgium)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 11, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2019

Study Completion

November 1, 2023

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)