Status:
RECRUITING
Vibration Applications After Total Knee Arthroplasty in Osteopenic Women
Lead Sponsor:
Istinye University
Conditions:
Osteopenia
Total Knee Arthroplasty
Eligibility:
FEMALE
60-75 years
Phase:
NA
Brief Summary
Osteoarthritis (OA) is a chronic degenerative disease characterized by the destruction of articular cartilage, leading to functional impairment of surrounding bone and soft tissues. It is a major glob...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 5 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06988033
Start Date
August 1 2025
End Date
December 5 2025
Last Update
November 17 2025
Active Locations (1)
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1
Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul, Uskudar, Turkey (Türkiye), 34668