Study Stopped
Research site unable to support further study requirements
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator Cemented Femoral Stems
1 other identifier
observational
75
0 countries
N/A
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) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2015
Longer than P75 for all trials
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
First Submitted
Initial submission to the registry
March 19, 2015
CompletedFirst Posted
Study publicly available on registry
March 25, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2021
CompletedDecember 20, 2022
December 1, 2022
6.5 years
March 19, 2015
December 16, 2022
Conditions
Keywords
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 (1)
Patient functional outcomes
Screening (First Available), 2-5 years, 5-7 years, and 10 years
Study Arms (1)
Total Hip Arthroplasty
Single group previously implanted with the following combination of components: PROFEMUR® Gladiator femoral stem, MicroPort acetabular shell, MicroPort Orthopedics polyethylene or ceramic liner, MicroPort Orthopedics metal or ceramic femoral head.
Interventions
Eligibility Criteria
Patients who have been previously implanted with PROFEMUR® Gladiator femoral stems
You may qualify if:
- 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 implanted with a metal-on-metal articulation
- Subjects implanted with non-MPO or non-Wright Medical Technology 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2015
First Posted
March 25, 2015
Study Start
July 1, 2015
Primary Completion
December 20, 2021
Study Completion
December 20, 2021
Last Updated
December 20, 2022
Record last verified: 2022-12