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:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT03037294
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Male and female patients scheduled for total knee arthroplasty
* BMI between 18.5-30 kg/m2
* Age \> 18 years
* Mentally competent, as judged by the treating physician
* Functioning gastrointestinal tract, eligible for oral protein supplementation
Exclusion Criteria:
* Corticosteroid injections less than 3 months prior to participation
* Any medications know to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications)
* Lactose intolerance
* Insulin-dependent diabetes mellitus
* Alcohol abuse
* Rheumatoid arthritis
* Peripheral artery disease Fontaine III or IV
* COPD GOLD III or IV
* Phenylketonuria
* Surgical intervention in the past four weeks
* Total parenteral nutrition at day of surgery
* Neoadjuvant chemotherapy or radiotherapy
* GFR \<20 mL/min/1.73 m2
* Osteoarthritis of the knee secondary to septic arthritis, osteonecrosis, fracture, OD, or malignant processes
* Collagen disorders, e.g. Marfan and Ehler-Danlos
* Any other medical condition that may interfere with the safety of the subjects or the outcome parameters, in the investigators judgement
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol instructions
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03037294
Study Brief:
Protocol Section:
NCT03037294