Clinical trial NCT04291833: Prospective, Assessment of Vitamin D and Calcium Supplementation, Improvement of Nutritional Status and Preoperative Rehabilitation in Patients Before Knee Arthroplasty.
Official title: Prospective, Assessment of Vitamin D and Calcium Supplementation, Improvement of Nutritional Status and Preoperative Rehabilitation in Patients Before Knee Arthroplasty.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Vitamin D Deficiency
Pain, Postoperative
Arthropathy of Knee
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 150
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective randomized study of 150 patients qualified for knee arthroplasty between 2015 and 2017. Patients were randomized into 3 groups receiving vitamin D and calcium supplementation, increased protein supply and preoperative rehabilitation, respectively.

Following factors were analyzed: changes in vitamin D3, calcium, total protein, albumin and CRP levels during preparation for surgery, nutritional status on the Subjective Global Assessment (SGA) scale, osteoporosis risk assessment according to the Osteoporosis Risk SCORE, level of pain felt on the scale VAS and the number of analgesics used, the result of the Duke Activity Status Index, the result of the following scales: Cardiac Risk Index for Orthopedic Surgery (Lee), Knee injury and Osteoarthritis Outcome Score (KOOS), Fear Avoidance Beliefs Questionnaire (FABQ) about Physical Activity, The Quality of Life Scale (QOLS). Additionally, the occurrence of perioperative complications was analyzed (e.g. venous thrombosis and pulmonary embolism, wound or joint infection, excessive bleeding, loosening of the implant, bone fracture or fracture, pain).


Eligibility criteria: Inclusion Criteria:

* with a disease lasting more than 5 years and without total limitation of physical fitness,
* reporting pain\> 5 on the VAS scale (Visual Analogue Scale)
* general fitness according to the ASA (Amercican Society of Anestesiology) scale up to 3

Exclusion Criteria:

* patients with metabolic and systemic disorders with contraindications for calcium substitution, vitamin D3 and protein supply,
* intolerance of physical effort\> 2, 5 MET (Metabolic Equivalent of Task)
* limitation of the degree overall efficiency\> 3 in the ASA classification

Primary outcomes:
measure: Pain control satisfaction assessed on the Visual Analogue Scale (VAS)
timeFrame: 18 months
measure: Vitamin D concentration in blood, based on laboratory analysis.
timeFrame: 18 months
measure: Efficiency of the knee joint assessed on The Knee Injury and Osteoarthritis Outcome Score (KOOS) scale.
timeFrame: 18 months
Secondary outcomes:
measure: Calcium ionized concentration in blood, based on laboratory analysis.
timeFrame: 18 months
measure: Total protein concentration in blood, based on laboratory analysis.
timeFrame: 18 months
measure: Albumin concentration in blood, based on laboratory analysis
timeFrame: 18 months
measure: C-reactive protein (CRP) concentration in blood, based on laboratory analysis
timeFrame: 18 months
measure: Efficacy of protein supplementation assessed on the Subjective Global Assessment (SGA) scale.
timeFrame: 18 months
measure: Efficacy of vitamin D and calcium supplementation assessed on the Simple Calculated Osteoporosis Risk Estimation (SCORE) scale.
timeFrame: 18 months
measure: Acceptability of physical activity based on Duke Activity Status Index (DASI) scale.
timeFrame: 18 months
measure: Incidence of cardiovascular hazard based on Cardiac Risk Index for Orthopedic Surgery (Lee) scale.
timeFrame: 18 months
measure: Unwillingness of phisical activity due to pain based on Fear Avoidance Beliefs Questionnaire (FABQ) scale.
timeFrame: 18 months
measure: The Quality of Life based on The Quality of Life (QOLS) scale.
timeFrame: 18 months
measure: Incidence of Treatment-Emergent Adverse Events (AE) as assessed by frequency.
timeFrame: 18 months
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Bartlomiej Szpyra
state: Malopolska
Study officials:
References: