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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT02798432
Eligibility Criteria:
Inclusion Criteria:
Patients may be included in the study only if they meet the following criteria:
* Patient is able to provide informed consent.
* Patient is between 18 and 75 years of age.
* Patients are willing and able to attend all follow-up visits and complete all study requirements. They must agree to comply with all study related procedure, including understanding and adhering to the rehabilitation protocol.
* Patient has primary or secondary knee osteoarthritis.
* Patient has sufficient bone quality for total knee arthroplasty.
* Patient is in stable health.
* Female patients are not pregnant at times of surgery and do not plan on becoming pregnant during the study.
Note: patient can only enter the project with one knee
Exclusion Criteria:
* Neuromuscular or vascular disease in the affected leg.
* Patients with osteoporosis based on former diagnosis or preoperative DEXA-scan.
* Fracture sequelae or previous HTO or previous extensive knee surgery.
* Patients with need of a stem-elongation.
* Patients who cannot refrain from taking NSAID post-operatively.
* Patients with metabolic bone disease.
* Patients with renal disease.
* Patients with rheumatoid arthritis.
* Postmenopausal women in estrogenic hormone substitution
* Patients with a continuous need of systemic cortisone treatment.
* Non-Spanish citizenship.
* Patients who do not comprehend the Spanish language (read and speak).
* Senile dementia.
* Alcohol abuse - defined as men drinking more than 21 units a week and women drinking more than 14 units a week.
* Drug abuse.
* Major psychiatric disease.
* Metastatic cancer disease and treatment with radiation therapy or chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02798432
Study Brief:
Protocol Section:
NCT02798432