Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant

A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Previously, most experimental studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that permit error due to undesired motions between markers and the underlying bone. More recently, fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.

ConforMIS has attempted to follow a clearly different path than the major orthopaedic companies. They have chosen to offer patients a personalized knee implant based off of each patient's femoral and tibial bone geometry. The hypothesis is that these subjects will experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25 patients implanted with a traditional TKA design to determine if there are any kinematic differences between these TKA designs.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Tennessee, Knoxville, Tennessee, United States

About this study

Each subject will be asked to perform five activities in one continuous sequence: (1) stand up from a chair, (2) walk up stairs, (3) walk down stairs, (4) level walking, and (5) a deep knee bend. Subjects will be video recorded from the waist down while performing the activities. The speed level of each trial will be based on the comfort level of the patient. The fluoroscopic images will be stored digitally for subsequent analysis on secure servers and workstations at the University of Tennessee.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

At least 6 months post-op with no other surgical procedures conducted within the past 6 months
Between 40-70 years of age
Body weight of less than 250lbs
BMI of less than 38
Pregnant females will be excluded
TKA patients will be judged Clinically successful with an American Knee Society score of greater than 90
Must have 100 degrees post-op passive flexion with no ligamentous laxity or pain
Participants must be able to walk on level ground without aid of any kind and ascend/descend stairs without assistance.
All potential subjects will have either a personalized ConforMIS™ TKA or a traditional TKA manufactured by an orthopaedic company other than ConforMIS.
Patients from the physician's list who do not meet the study requirements will not be considered.
Patients must be willing to sign the Informed Consent and HIPAA forms to participate in the study.
Patients must be between 160cm (5'3) and 193cm (6'4) tall.

Treatment and study plan

Primary outcomes

Post-operative Range of Motion

Time frame: at least 6 months post-surgery

Comparison of amount of flexion achieved by the knee between the two arms

Sponsors and collaborators

Lead sponsor

Restor3D

Industry

Registry information

Official study title

In Vivo Determination & Comparison of Knee Kinematics for Subjects Implanted With Either a Personalized ConforMIS or Traditional Knee Implant

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Oct 30, 2012
Registry last updated: Oct 25, 2023

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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Completed