Status:
COMPLETED
In Vivo Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant
Lead Sponsor:
Restor3D
Conditions:
Complications; Arthroplasty
Eligibility:
All Genders
40-70 years
Brief 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 close...
Detailed Description
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. Subj...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01882751
Start Date
June 1 2013
End Date
August 1 2017
Last Update
October 25 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Tennessee Orthopaedic Clinics
Knoxville, Tennessee, United States, 37923
2
University of Tennessee
Knoxville, Tennessee, United States, 37996