N/A
N=66
Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01717001 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Post-operative Range of Motion — 103.8; 95.8 degrees
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Restor3D
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Range of Motion |
103.8; 95.8 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01717001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.