In Vivo Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant
Completed
Conditions studied: Complications; Arthroplasty
In brief
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.
Key facts
- Study ID
- NCT01882751
- Run by
- Restor3D
- People needed
- 66
- Starts
- 2013-06-01
- Expected to finish
- 2017-08-01
- Last updated by the study team
- 2023-10-25
Who can join
Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- At least 6 months post-op
- Between 40-70 years of age
- Body weight of less than 250lbs
- TKA patients will be judged clinically successful with an American Knee Society score of greater than 90
- Must have post-op passive flexion of 100 degrees with no ligamentous laxity or pain
- Participants must be able to walk on level ground without aids and ascend/descend stairs without assistance.
- Subjects will either a ConforMIS™ TKA or a traditional TKA manufactured by any other orthopaedic company.
- Patients must be between 160cm (5'3) and 193cm (6'4) tall.
You may not qualify if…
- Subjects not willing to sign the Informed Consent and HIPAA forms to participate in the study
- BMI >40
- Pregnant females
- Surgical procedures conducted within the past 6 months other than TKA
- Subjects from the physician's list who do not meet study requirements
- Unwilling or unable to comply with study requirements
- Participation in another clinical study which would confound results
Where it is running
- Tennessee Orthopaedic Clinics — Knoxville, Tennessee, United States
- University of Tennessee — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
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