Prospective, Assessment of Vitamin D and Calcium Supplementation, Improvement of Nutritional Status and Preoperative Rehabilitation in Patients Before Knee Arthroplasty.

Knee Osteoarthritis Clinical Trial

Official title:

Prospective, Assessment of Vitamin D and Calcium Supplementation, Improvement of Nutritional Status and Preoperative Rehabilitation in Patients Before Knee Arthroplasty.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04291833
• Other study ID #: KBET/271/B/2014
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2020
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Knee
• Joint Diseases
• Knee Osteoarthritis
• Osteoarthritis, Knee
• Pain, Postoperative
• Vitamin D Deficiency

Intervention

Behavioral:
• Intervention group 1
Protein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months
• Intervention group 2
Protein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months
• Control group 0
no protein supplementation , no Vitamin D and calcium supplementation , no exercise

Locations

Country	Name	City	State
Poland	Bartlomiej Szpyra	Kraków	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Calcium ionized concentration in blood, based on laboratory analysis.	Calcium ionized concentration in blood is a laboratory parameter, measured in unit of mmol/l. The results below 1.16 mmol/l mean that the level is not sufficient, condition called hypocalcemia. Values between 1.16-1.32 mmol/l are considered normal. The results above 1.32 mmol/l mean hypercalcemia occurs. This is one of the basic laboratory parameters for assessing the body's bone mineral metabilism.	18 months
Secondary	Total protein concentration in blood, based on laboratory analysis.	Total protein concentration in blood is a laboratory parameter, measured in unit of g/l. The results below 60 g/l mean that the level is not sufficient, condition called hypoproteinemia. Values between 60-80 g/l are considered normal. The results above 80 g/l mean hyperproteinemia occurs. This is one of the basic laboratory parameters for assessing the body's nutritional status.	18 months
Secondary	Albumin concentration in blood, based on laboratory analysis	Albumin concentration in blood is a laboratory parameter, measured in unit of mg/ml. The results below 35 mg/l mean that the level is not sufficient, condition called hypoalbuminemia. Values between 35-50 mg/ml are considered normal. The results above 50mg/l mean hyperalbuminemia occurs. This is one of the basic laboratory parameters for assessing the body's nutritional status.	18 months
Secondary	C-reactive protein (CRP) concentration in blood, based on laboratory analysis	C-reactive protein concentration in blood is a laboratory parameter, measured in unit of mg/l. The results below 5 mg/l are considered normal. The results above 5mg/l mean infection, trauma, stress or other aggravating factor. This is the major laboratory parameter for assessing homeostatic balance.	18 months
Secondary	Efficacy of protein supplementation assessed on the Subjective Global Assessment (SGA) scale.	Subjective global assessment (SGA) is the gold standard for diagnosing malnutrition. SGA is a simple bedside questionnaire method used to diagnose malnutrition and identify those who would benefit from nutrition care. The assessment includes taking a history of recent intake, weight change, gastrointestinal symptoms and a clinical evaluation. Results are on a scale from 1 to 7. Values 1 and 2 means high risk of malnutririon, from 3 do 5 medium risk, and from 6 do 7 mild risk.	18 months
Secondary	Efficacy of vitamin D and calcium supplementation assessed on the Simple Calculated Osteoporosis Risk Estimation (SCORE) scale.	Simple Calculated Osteoporosis Risk Estimation (SCORE) scale is the questionnaire tool for diagnosing Osteoporosis risk. It has been reported to appropriately identify person who should be referred for bone densitometry. Results are on a scale from 0 to 50 points. Points from 16 to 50 means high risk of osteoporosis , points from 7 to 15 moderate risk and from 0 do 6 low risk of osteoporosis.	18 months
Secondary	Acceptability of physical activity based on Duke Activity Status Index (DASI) scale.	The Duke Activity Status Index is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. Results are on a scale from 0 to 57,95 points. The higher the score, the more intense the acceptable physical activity.	18 months
Secondary	Incidence of cardiovascular hazard based on Cardiac Risk Index for Orthopedic Surgery (Lee) scale.	Cardiac Risk Index for Orthopedic Surgery (Lee) is the questionnaire tool for diagnosing cardiovascular hazard in orthopedics patients. Results are on a scale from 0 to 6 points. Points from 3 to 6 means estimated risk of 4%, 2 points is 2,3% of risk, 1 point is 1,7% of risk and 0 points means less than 1 % of cardiovascular event.	18 months
Secondary	Unwillingness of phisical activity due to pain based on Fear Avoidance Beliefs Questionnaire (FABQ) scale.	Fear Avoidance Beliefs Questionnaire (FABQ) scale is a questionnaire based on the Fear-Avoidance Model of Exaggerated Pain Perception, a model created in attempts to explain why some patients with acute painful conditions can recover while other patients develop chronic pain from such conditions. The FABQ focuses specifically on how a patient's fear-avoidance beliefs about physical activity and work. It consists of 16 questions scaled form 0 do 6, higher score indicates fear avoidance behaviors.	18 months
Secondary	The Quality of Life based on The Quality of Life (QOLS) scale.	The Quality of Life (QOLS) scale is the most known scale measures factors like satisfaction, perceptions of control, involvement, commitment, and work-life balance, in terms of one's personal perception. QOLS has 16 items, scaled form 1 do 7, higher score indicates superior appraisal of each aspect of life.	18 months
Secondary	Incidence of Treatment-Emergent Adverse Events (AE) as assessed by frequency.	Incidence of Adverse Events (AE) was summed up and analyzed in each group. They were divided into 7 groups.; - a serous wound leak requiring albumin transfusion; - bleeding that requires RBC transfusion; - perioperative infection; - postoperative infection; - pulmonary embolism; - other; - death. Every case was appropriately assigned, analyzed and evaluated.	18 months