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NCT Number: NCT04221581

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Pasteur, Colmar, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis

Device

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

Primary outcomes

  1. Safety evaluation

    Time frame: 10 years post-op

    Survival rate

Secondary outcomes

  1. Radiological evaluation

    Time frame: preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op

    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.

  2. Rate of complications

    Time frame: peroperative, 3 months postoperative, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op

    All complications will be gathered during intervention and up to 10 years postoperatively.

  3. Functional outcomes such as pain, mobility.

    Time frame: preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op

    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).

Sponsors and collaborators

Lead sponsor

FH ORTHO

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2034
Study completion
2034
First posted
Jan 9, 2020
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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