Study Conducted on Patients Operated With a FHK ASYMETRIQUE to Confirm Security and Performance of the Device
Prospective Observational Clinical Study Conducted on Patient Operated With a Total Knee Prosthesis FHK ASYMETRIQUE to Confirm Security and Performance of the Device Over a Period of 10 Years
1 other identifier
observational
43
1 country
3
Brief Summary
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the FHK asymetrique prosthesis, which is intended to be implanted in case of total knee replacement, when used in real life conditions according to the instructions for use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2020
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2019
CompletedFirst Posted
Study publicly available on registry
January 9, 2020
CompletedStudy Start
First participant enrolled
January 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 22, 2034
February 22, 2024
February 1, 2024
14 years
December 18, 2019
February 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety evaluation
Survival rate
10 years post-op
Secondary Outcomes (3)
Radiological evaluation
preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Rate of complications
peroperative, 3 months postoperative, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Functional outcomes such as pain, mobility.
preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Study Arms (1)
Patients receiving FHK ASYMETRIQUE prosthesis
Interventions
FHK ASYMETRIQUE prosthesis are intended to be implanted in the tibial and femoral regions during total knee arthroplasty in order to restore joint function.
Eligibility Criteria
Patients from participating hospitals will be enrolled as part of their clinical routine care
You may qualify if:
- Adults subjects (≥18 years old).
- Subject implanted with FHK ASYMETRIQUE prosthesis in one of the following indication according to the instructions for use: knee disorders; Aseptic condylar necrosis.
- Subject who received an information form and is willing to participate in the study.
You may not qualify if:
- Contraindications described in the instructions for use
- Usual surgical contraindications
- Patients objecting to participate in this study
- Subject who is not able to express his/her non-opposition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- FH ORTHOlead
Study Sites (3)
CH Pasteur
Colmar, 68000, France
Clinique Mutualiste de la Porte de l'Orient
Lorient, 56324, France
Médipôle Garonne
Toulouse, 31036, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2019
First Posted
January 9, 2020
Study Start
January 22, 2020
Primary Completion (Estimated)
January 22, 2034
Study Completion (Estimated)
January 22, 2034
Last Updated
February 22, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share