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 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT02469792
Eligibility Criteria:
Inclusion Criteria:
* Patient suffers from partial rupture of anterior cruciate ligament (confirmed by MRI or knee arthroscopic surgery)
* Clinically significant knee instability (positive anterior drawer test, pivot shift test, and Lachman test)
* Patient is familiar with Participant information sheet
* Patient signed informed consent form
Non-inclusion Criteria:
* Knee osteoarthritis grade III and grade IV
* Medical history of autoimmune diseases
* Patients prescribed for immunosuppressive treatment
* Contraindications to the general or local anesthesia or medical history of allergic reactions to anesthetics
* Subcompensated or decompensated forms of chronic diseases of internal organs
* Significant weight loss (\> 10% of body weight in the previous year) of unknown etiology
* Medical history of venous thromboembolism or estimated high risk of venous thromboembolism
* Clinically significant abnormalities in results of laboratory tests
* Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
* Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
* Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy.
* Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times
* Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior lipoaspiration
* Medical history of heterotopic ossifications
* Patients prescribed for glycoprotein inhibitors treatment
Exclusion Criteria:
* Patient's refusal from the further participation in trial
* Patient's refusal from compliance with the requirements of contraception during the participation in research
* Chronic kidney disease IV - V stages (creatinine clearance \< 30 mL/min estimated by Cockroft-Gault formula)
* Confirmed syphilis, HIV, hepatitis B or C infections
Dropout Criteria:
* Complete anterior cruciate ligament rupture confirmed by knee arthroscopic surgery
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02469792
Study Brief:
Protocol Section:
NCT02469792