Clinical trial NCT06988033: Vibration Applications After Total Knee Arthroplasty in Osteopenic Women
Official title: Effects of Different Vibration Applications on Bone Turnover Markers and Functionality After Total Knee Arthroplasty in Women With Osteopenia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteopenia
Total Knee Arthroplasty
Keywords: Total Knee Arthroplasty
Osteopenia
Vibration
Women
Bone Turnover Markers
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 48
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three parallel arms: Whole Body Vibration (WBV), WBV with exercise, or Control (standard rehabilitation). Each arm will receive a distinct intervention protocol concurrently over the same study period.
Primary purpose: TREATMENT

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 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.


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

Primary outcomes:
measure: Timed Up and Go (TUG) Test Score
timeFrame: Baseline (Week 4 post-op) and 12th week (Post-intervention)
measure: Bone Turnover Marker (Serum Procollagen Type I N-terminal Propeptide (PINP) Level)
timeFrame: Pre-surgery, Week 4, Week 12
measure: Bone Turnover Marker (Serum Osteocalcin (OCN) Level)
timeFrame: Pre-surgery, Week 4, Week 12
measure: Bone Turnover Marker (Serum C-terminal Telopeptide of Type I Collagen (CTX) Level)
timeFrame: Pre-surgery, Week 4, Week 12
measure: Bone Turnover Marker (Serum N-terminal Telopeptide of Type I Collagen (NTX) Level)
timeFrame: Pre-surgery, Week 4, Week 12
measure: 30-Second Chair Stand Test
timeFrame: Week 4 and Week 12
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Week 4 and Week 12
measure: Muscle Strength (Isometric)
timeFrame: Week 4 and Week 12
measure: Pain Pressure Threshold (PPT)
timeFrame: Week 4 and Week 12
Secondary outcomes:
measure: Pain Intensity (Visual Analog Scale)
timeFrame: Week 4 and Week 12
measure: Knee Range of Motion (ROM)
timeFrame: Week 4 and Week 12
measure: Proprioception (Joint Position Sense)
timeFrame: Week 4 and Week 12
measure: Knee Edema Volume
timeFrame: Week 4 and Week 12
measure: Biomechanical Muscle Properties (Muscle Tone of Quadriceps)
timeFrame: Week 4 and Week 12
measure: Biomechanical Muscle Properties (Muscle Stiffness of Quadriceps)
timeFrame: Week 4 and Week 12
measure: Biomechanical Muscle Properties (Muscle Elasticity of Quadriceps)
timeFrame: Week 4 and Week 12
measure: Biomechanical Muscle Properties (Muscle Relaxation Time of Quadriceps)
timeFrame: Week 4 and Week 12
measure: Biomechanical Muscle Properties (Muscle Creep of Quadriceps)
timeFrame: Week 4 and Week 12
Other outcomes:
measure: Perceived Exertion Level (Borg-RPE15 Scale)
timeFrame: At each exercise session from Week 1 to Week 12
Locations:
city: Istanbul
country: Turkey
facility: Sultan 2. Abdulhamid Han Training and Research Hospital
state: Uskudar
Study officials:
affiliation: Istinye University
name: GÜL D YILMAZ YELVAR, ASSOCIATE PROFESSOR
role: STUDY_CHAIR
References:
citation: He Z, Zheng J, Liu S, Guan Z, Zhou Q, Jin X, Guan Z. The effect of whole-body vibration in osteopenic patients after total knee arthroplasty: a randomized controlled trial. Aging Clin Exp Res. 2022 Jun;34(6):1381-1390. doi: 10.1007/s40520-021-02043-2. Epub 2022 Jan 14.
citation: Gazdzik TS, Gajda T, Kaleta M. Bone mineral density changes after total knee arthroplasty: one-year follow-up. J Clin Densitom. 2008 Jul-Sep;11(3):345-50. doi: 10.1016/j.jocd.2008.04.007. Epub 2008 Jul 10.
citation: Cardinale M, Bosco C. The use of vibration as an exercise intervention. Exerc Sport Sci Rev. 2003 Jan;31(1):3-7. doi: 10.1097/00003677-200301000-00002.
citation: Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
citation: Klug A, Gramlich Y, Rudert M, Drees P, Hoffmann R, Weissenberger M, Kutzner KP. The projected volume of primary and revision total knee arthroplasty will place an immense burden on future health care systems over the next 30 years. Knee Surg Sports Traumatol Arthrosc. 2021 Oct;29(10):3287-3298. doi: 10.1007/s00167-020-06154-7. Epub 2020 Jul 15.
citation: Sowers M. Epidemiology of risk factors for osteoarthritis: systemic factors. Curr Opin Rheumatol. 2001 Sep;13(5):447-51. doi: 10.1097/00002281-200109000-00018.