Study Conducted on Patients Operated With a FHK ASYMETRIQUE to Confirm Security and Performance of the Device

Knee Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04221581
• Other study ID #: 2018-38
• Status: Active, not recruiting
• Start date: January 22, 2020
• Est. completion date: January 22, 2034

Study information

• Verified date: February 2024
• Source: FH ORTHO
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The primary objective of this study is to evaluate the security of the FHK ASYMETRIQUE prosthesis by calculating the survival rate up to 10 years of follow-up. The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score up to 10 years of follow-up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: January 22, 2034
• Est. primary completion date: January 22, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Knee Disease

Intervention

Device:
• Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis
FHK ASYMETRIQUE prosthesis are intended to be implanted in the tibial and femoral regions during total knee arthroplasty in order to restore joint function.

Locations

Country	Name	City	State
France	CH Pasteur	Colmar
France	Clinique Mutualiste de la Porte de l'Orient	Lorient
France	Médipôle Garonne	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
FH ORTHO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety evaluation	Survival rate	10 years post-op
Secondary	Radiological evaluation	Radiological results such as stability, osteointegration will be evaluated. The HKA angle will be measured. It is the angle (in degrees) between the center of the femoral head, the center of the knee and the center of the tibio-fibular mortise. This radiological evaluation is a usual assessment used in the follow-up of patients operated for a total knee replacement.	preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Secondary	Rate of complications	All complications will be gathered during intervention and up to 10 years postoperatively.	peroperative, 3 months postoperative, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Secondary	Functional outcomes such as pain, mobility.	Functional outcomes will be determined by the IKS score. New IKS score range from 0 to 200 with a physical score on 100 points (pain, knee's mobility, abnormal laxity, flexion deformity and Hips knee Ankle) and a functional score on 100 points (walking distance, difficulty with stairs and use of walking aids).	preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op