Whole-body vibration after knee replacement for women with low bone density
Effects of Different Vibration Applications on Bone Turnover Markers and Functionality After Total Knee Arthroplasty in Women With Osteopenia: A Randomized Controlled Trial
NA · Istinye University · NCT06988033
This trial will test whether adding whole-body vibration, with or without exercise, after knee replacement helps protect bone and speed recovery in women with osteopenia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 60 Years to 75 Years |
| Sex | Female |
| Sponsor | Istinye University (other) |
| Locations | 1 site (Istanbul, Uskudar) |
| Trial ID | NCT06988033 on ClinicalTrials.gov |
What this trial studies
Women with osteopenia scheduled for unilateral, primary cemented total knee arthroplasty will receive one of three postoperative approaches: whole-body vibration therapy, whole-body vibration combined with exercise, or conventional physiotherapy. Eligible participants must have a recent DXA T-score between -2.5 and -1 and be able to understand Turkish and provide consent. The study will follow patients after surgery and collect measures such as bone turnover markers, bone mineral density, and functional outcomes to see whether vibration limits early post‑operative bone loss and improves muscle function. The trial is conducted at Sultan 2. Abdulhamid Han Training and Research Hospital under Istinye University.
Who should consider this trial
Good fit: Ideal candidates are Turkish-speaking women with knee osteoarthritis scheduled for a primary, unilateral cemented TKA who have osteopenia (DXA T-score between -2.5 and -1) and can comply with postoperative rehabilitation.
Not a fit: Patients unlikely to benefit include men, those without osteopenia, individuals scheduled for revision TKA, or people with major comorbidities, neurological or vestibular disorders, dementia, or other listed exclusions.
Why it matters
Potential benefit: If successful, the approach could reduce early bone loss after knee replacement, improve quadriceps strength and recovery, and lower the risk of implant loosening.
How similar studies have performed: Small prior trials of whole-body vibration in older adults have shown modest gains in muscle strength and some bone markers, but results are mixed and evidence specific to the post‑TKA osteopenic population is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Istanbul, Uskudar
- Sultan 2. Abdulhamid Han Training and Research Hospital — Istanbul, Uskudar, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: EBRU ALOĞLU ÇİFTÇİ
- Email: ebrualogluciftci@gmail.com
- Phone: +90-216-677-1630 ext.3555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteopenia, Total Knee Arthroplasty, Vibration, Women, Bone Turnover Markers