Prospective, Assessment of Vitamin D and Calcium Supplementation, Improvement of Nutritional Status and Preoperative Rehabilitation in Patients Before Knee Arthroplasty.
1 other identifier
interventional
150
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Jan 2015
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedFirst Submitted
Initial submission to the registry
February 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 2, 2020
CompletedMarch 2, 2020
February 1, 2020
3 years
February 27, 2020
February 28, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Pain control satisfaction assessed on the Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) is a measure determining the intensity of pain by means of a visual analogue scale. Subject is marking the examined point on a line of 10 cm long, where the value 0 is assigned the total absence of pain, and 10 the strongest pain that can be imagined.
18 months
Vitamin D concentration in blood, based on laboratory analysis.
Concentration of vitamin D in blood is a laboratory parameter, measured in unit of ng/ml. Levels below 20 ng/ml is a severe vitamin D deficiency condition that requires treatment. The result in the range 20-30 ng/ml means that the vitamin level is not sufficient. Values between 30-50 ng/ml are considered normal. This is one of the basic laboratory parameters for assessing the body's bone mineral metabilism.
18 months
Efficiency of the knee joint assessed on The Knee Injury and Osteoarthritis Outcome Score (KOOS) scale.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
18 months
Secondary Outcomes (11)
Calcium ionized concentration in blood, based on laboratory analysis.
18 months
Total protein concentration in blood, based on laboratory analysis.
18 months
Albumin concentration in blood, based on laboratory analysis
18 months
C-reactive protein (CRP) concentration in blood, based on laboratory analysis
18 months
Efficacy of protein supplementation assessed on the Subjective Global Assessment (SGA) scale.
18 months
- +6 more secondary outcomes
Study Arms (3)
Intervention group 1
ACTIVE COMPARATORProtein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months
Intervention group 2
ACTIVE COMPARATORProtein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months
Control group 0
PLACEBO COMPARATORno protein supplementation , no Vitamin D and calcium supplementation , no exercise
Interventions
Protein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months
Protein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months
no protein supplementation , no Vitamin D and calcium supplementation , no exercise
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bartlomiej Szpyra
Krakow, Malopolska, 31-559, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 27, 2020
First Posted
March 2, 2020
Study Start
January 1, 2015
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
March 2, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share