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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT05570760
Eligibility Criteria:
Inclusion Criteria:
* Subjects aged between 25 and 65 years at the time of enrolment.
* Subjects that sign and date a written, informed consent form (ICF) prior to the initiations of any trial procedures, after the nature of the trial has been explained according to regulatory requirements.
* Subjects who can comply with trial procedures and are available for the duration of the trial.
* Accepts all treatment arms.
* Subjects with varus malalignment of the knee, scheduled to have medial open-wedge high tibial osteotomy (OWHTO) but are otherwise in good health at the time of entry into the trial as determined by medical history, physical/clinical examination, and clinical judgement of the investigator.
* Full knee range of motion (ROM) (at least 5-120 degrees).
* Preoperatively planned osteotomy 5-13 degrees of the proximal tibia done based on the weight-bearing x-ray of the full leg in AP view using Miniaci Method.
* Body Mass Index (BMI) ≤30
Exclusion Criteria:
* Previous knee area osteotomy or lower limb arthroplasty of the investigational knee.
* Presence of the following unfavourable conditions: osteoporosis, infectious/inflammatory joint disease, infections, or inflammation in the operation area, clinically relevant, not medically managed, severe acute or chronic medical illness, immune-compromised, metabolic/systemic bone disorder, untreated malignant myeloma, Burkitt's lymphoma, lateral osteoarthritis (Kellgren-Lawrence grade \>1)
* Smoking or use of other nicotine products
* Inability to follow the procedures of the study, e.g. due to language problems, dementia, psychiatric disorder or behaviour etc. of the participant
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment.
* Women who are pregnant or breast feeding or planning to become pregnant during the study.
* Any use of calcitonin, bisphosphonates or recombinant PTH 1-34, 1-84 or other PTH fragments/analogues 6 months prior to surgery or during the study (12 months po).
* Enrolment of the investigator, his/her family members, employees, and other dependent persons.
* Involved in study of another investigational product that may affect outcome.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT05570760
Study Brief:
Protocol Section:
NCT05570760