Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT01882751
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT01882751
Study Brief:
Protocol Section:
NCT01882751