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 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT00380861
Eligibility Criteria:
Inclusion Criteria:
* Non-Inflammatory Arthritis
* Age = 40-70 years
* Male or female
* Suitable for devices in study
* Needing primary simultaneous bilateral knee replacements
* Willing to consent and authorize release of personal health information
* Subjects who are able to understand this clinical investigation, co-operate with investigational procedures and are willing to return to the clinic, hospital and predefined physical therapy centers for all the required postoperative follow-ups,
Exclusion Criteria:
* Existing conditions that would compromise participation
* Multiple joint involvement
* Pregnant/lactating women
* Inflammatory arthritis
* Fixed flexion contracture greater than 20 degrees
* Previous knee replacement of any type
* Needing device(s) not specified in protocol
* The Subject is a known drug or alcohol abuser or has a psychological disorder that would compromise follow-up
* Those who have participated in an investigation in the last 3 months
* Those involved in personal injury litigation, medical-legal or workers compensation claims
* Failure to follow surgical technique details specified in the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT00380861
Study Brief:
Protocol Section:
NCT00380861