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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT06988033
Eligibility Criteria:
Inclusion Criteria:
* Scheduled to undergo unilateral, primary, cemented total knee arthroplasty (TKA) using a posterior cruciate ligament-sacrificing technique and medial parapatellar approach due to knee osteoarthritis
* Ability to speak and understand Turkish
* Ability to comprehend both verbal and written information
* A T-score between -2.5 and -1 (i.e., -2.5 \< T-score \< -1) measured by DXA in the lumbar spine, total hip, or femoral neck within the past year
Exclusion Criteria:
* Scheduled for revision TKA
* American Society of Anesthesiologists (ASA) physical status classification score higher than 3
* History of major surgery on the limb to be operated
* Presence of comorbid diseases such as rheumatoid arthritis or cancer
* Presence of a neurological condition causing functional impairment
* Diagnosed psychiatric disorder
* Dementia
* Disorders affecting the vestibular system
* Having undergone anesthesia for any reason within the last month
* Regular use of hypnotic or anxiolytic medications
* Hearing or vision impairment not correctable by hearing aids or glasses
* Presence of endocrine system disorders
* Secondary osteoporosis or history of osteoporotic fracture
* Metabolic bone diseases or chronic illnesses potentially affecting bone metabolism
* Use of medications known to affect bone metabolism (e.g., menopausal hormone therapy, bisphosphonates, raloxifene, calcitonin, growth hormone, parathyroid hormones, corticosteroids) within 6 months prior to the start of the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
60 Years
Maximum Age:
75 Years
Study:
NCT06988033
Study Brief:
Protocol Section:
NCT06988033