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 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT03017261
Eligibility Criteria:
Inclusion Criteria:
1. At least 21 years of age.
2. Skeletally mature, as evidenced by closed epiphyses.
3. Eligible for primary unilateral TKA due to osteoarthritis defined radiographically by a Kellgren-Lawrence Grade of 3 or higher.
4. Able to understand and willing to comply with the requirements of the study.
5. Able to give voluntary, written informed consent to participate and has signed an Informed Consent Form specific to this study.
Exclusion Criteria:
1. Has undergone previous open knee surgery in the operative knee.
2. Has a body mass index (BMI) \> 40 kg/m2.
3. Is a candidate for bilateral TKA.
4. Has a coronal deformity greater than 20° or a sagittal flexion contracture greater than 15°.
5. Has an active systemic infection or an active local infection in or near the operative knee joint, or has a previous history of joint infection.
6. Has a pathological skeletal condition or skeletal immaturity which would significantly compromise the ability of the bone to withstand the stress required for preparation of the bones and proper implantation of the prostheses (e.g., severe osteoporosis, Paget's disease, renal osteodystrophy, AVN, sickle cell disease, etc.).
7. Has femoral or tibial bone stock that is of poor quality or inadequate to provide stability for femoral or tibial fixation.
8. Has any type of metallic implant in the operative leg.
9. Has a known or suspected sensitivity to any of the materials in the investigational device or implant components (i.e. cobalt, chromium, titanium, stainless steel, titanium nitride, aluminum, polyethylene, PVC plastic)
10. Has a systemic illness or a neuromuscular, neurosensory, or musculoskeletal deficiency that would render the patient unable to perform appropriate postoperative rehabilitation.
11. Has a neuromuscular disorder that would create an unacceptable risk of prosthesis instability or fixation failure.
12. Has significant comorbidities or conditions associated with high risk for surgical or anesthetic survival (e.g. peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.).
13. Is pregnant or intends to become pregnant during the course of the study.
14. Has previously experienced a stroke.
15. Is participating concurrently in another clinical trial, or has participated in a clinical trial within the last 90 days, or intends to during the course of the study.
16. Has a medical or psychiatric condition which, in the opinion of the investigator, poses a risk of the patient being unable to complete the study or presents risks associated with study participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03017261
Study Brief:
Protocol Section:
NCT03017261