Actively Recruiting
Vibration Applications After Total Knee Arthroplasty in Osteopenic Women
Led by Istinye University · Updated on 2025-11-17
48
Participants Needed
1
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 global public health problem, with the knee joint being the most commonly affected site. Treatment modalities include exercise, diet, oral non-steroidal anti-inflammatory drugs (NSAIDs), intra-articular injections, and total knee arthroplasty (TKA). TKA is indicated in cases of severe pain, functional loss, deformity, and limited range of motion when conservative methods are no longer effective. However, some patients may continue to experience deformity and functional deficits after surgery. Postoperative quadriceps weakness and decreased functional capacity can negatively affect patient prognosis. Following TKA, bone mineral density (BMD) tends to decrease during the first three months. The reduction in BMD and the increase in bone resorption may elevate the risk of implant loosening or periprosthetic fracture. Bone turnover markers (BTMs), which are enzymes or degradation products released into circulation by bone cells, reflect bone remodeling processes and can help identify increased fracture risk. A significant proportion of TKA candidates are osteopenic. Since osteopenic individuals make up a larger segment of the population, most fragility fractures actually occur in individuals with osteopenia rather than osteoporosis. Therefore, BMD levels and the presence of osteopenia or osteoporosis should be taken into account in patients undergoing TKA. To preserve both bone quality and muscle mass, early rehabilitation and progressive weight-bearing on the operated limb are considered essential. These strategies may improve both BMD and BTMs. Whole-body vibration (WBV) therapy has been suggested as an effective and safe method to increase mechanical loading on the bones. WBV can be applied in a static standing position on a vibration platform or combined with simultaneous exercise. Given the limited availability of targeted strategies to improve bone remodeling and BTMs after TKA, and the lack of clarity regarding the optimal WBV protocol, this study aims to investigate the effects of different vibration applications on bone turnover markers, functionality, muscle strength, pain intensity, pressure pain threshold, range of motion, proprioception, edema, and muscle biomechanical properties in osteopenic women following TKA. Participants will be randomly assigned to one of three groups: WBV only, WBV combined with exercise (WBV-E), or control. All groups will receive traditional rehabilitation three times per week for four weeks after surgery. WBV interventions will begin at the end of the fourth postoperative week, once patients are deemed ready. While WBV groups will receive additional vibration therapy, the control group will continue traditional rehabilitation alone. Outcomes will be evaluated using bone turnover markers, the Timed Up and Go (TUG) test, the 30-Second Chair Stand Test, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), measurements of muscle biomechanical properties and strength, pain intensity and pressure pain threshold, joint range of motion, proprioception, and edema.
CONDITIONS
Official Title
Vibration Applications After Total Knee Arthroplasty in Osteopenic Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled to have a first-time, single knee replacement surgery using a specific surgical technique for knee osteoarthritis
- Able to speak and understand Turkish
- Able to understand spoken and written study information
- Bone density T-score between -2.5 and -1 measured in lumbar spine, hip, or femoral neck within the last year
You will not qualify if you...
- Scheduled for revision knee replacement surgery
- Classified as American Society of Anesthesiologists physical status higher than 3
- History of major surgery on the leg to be operated
- Having rheumatoid arthritis or cancer
- Having a neurological condition causing functional problems
- Diagnosed psychiatric disorder
- Dementia
- Vestibular system disorders
- Received anesthesia within the last month
- Regularly using hypnotic or anxiety medications
- Hearing or vision problems not corrected by aids
- Endocrine system disorders
- Secondary osteoporosis or past osteoporotic fractures
- Metabolic bone diseases or chronic illnesses affecting bones
- Use of bone metabolism-affecting medications within 6 months before the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul, Uskudar, Turkey (Türkiye), 34668
Actively Recruiting
Research Team
E
EBRU ALOĞLU ÇİFTÇİ
CONTACT
M
MEHMET UTKU ÇİFTÇİ, MD (Doctor of Medicine)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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