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 @ 12:11 PM
Ignite Modification Date:
2025-12-24 @ 12:11 PM
NCT ID:
NCT02373761
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic osteoarthritis of the knee indicating surgical intervention
* Scheduled to undergo a total knee arthroplasty
* Patients between the ages of 18 and 80, inclusive
* Patient is a candidate for Triathlon Tritanium cementless knee components implanted in accordance with product labeling
Exclusion Criteria:
* Significant co-morbidity affecting ability to ambulate
* Prior arthroplasty, patellectomy or osteotomy with the affected knee
* Active or prior infection of the affected knee
* Morbid obesity (BMI \> 40)
* Medical condition precluding major surgery
* Severe osteoporosis
* Neuromuscular impairment
* Pregnancy
* Inability to give informed consent
* Inability to return for follow-up visits for a minimum of two years after surgery
* Currently participating in any other surgical intervention study
* Known allergy to metals
* Flexion contracture greater than 15°
* Extension lag greater than 10°
* Tibial subluxation greater than 10 mm on standing AP radiograph
* Lateral or medial collateral ligament instability (\> 10° varus/valgus)
* Leg length discrepancy greater than 10 mm
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02373761
Study Brief:
Protocol Section:
NCT02373761