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 @ 2:09 PM
Ignite Modification Date:
2025-12-24 @ 2:09 PM
NCT ID:
NCT01180595
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic osteoarthritis of the knee indicating surgical intervention
* Between the ages of 21 and 80 inclusive
* Ability to give informed consent
Exclusion Criteria:
* Significant co-morbidity affecting ability to ambulate
* Flexion contracture greater than 15°
* Extension lag greater than 10°
* Tibial subluxation greater than 10 mm on standing AP radiograph
* Prior arthroplasty, patellectomy or osteotomy with the affected knee
* Lateral or medial collateral ligament instability (\> 10° varus/valgus)
* Leg length discrepancy greater than 10 mm
* Active or prior infection
* Morbid Obesity (BMI \> 40)
* Medical condition precluding major surgery
* Severe osteoporosis or osteopenia
* Neuromuscular impairment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT01180595
Study Brief:
Protocol Section:
NCT01180595