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

Primary Purpose

Knee Osteoarthritis, Vitamin D Deficiency, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Intervention group 1
Intervention group 2
Control group 0
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Knee Osteoarthritis

Eligibility Criteria

undefined - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bartlomiej Szpyra

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Intervention group 1

Intervention group 2

Control group 0

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 27, 2020
Last Updated
February 28, 2020
Sponsor
Jagiellonian University
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1. Study Identification

Unique Protocol Identification Number
NCT04291833
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Vitamin D Deficiency, Pain, Postoperative, Arthropathy of Knee

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group 1
Arm Type
Active Comparator
Arm Description
Protein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months
Arm Title
Intervention group 2
Arm Type
Active Comparator
Arm Description
Protein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months
Arm Title
Control group 0
Arm Type
Placebo Comparator
Arm Description
no protein supplementation , no Vitamin D and calcium supplementation , no exercise
Intervention Type
Behavioral
Intervention Name(s)
Intervention group 1
Intervention Description
Protein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months
Intervention Type
Behavioral
Intervention Name(s)
Intervention group 2
Intervention Description
Protein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months
Intervention Type
Behavioral
Intervention Name(s)
Control group 0
Intervention Description
no protein supplementation , no Vitamin D and calcium supplementation , no exercise
Primary Outcome Measure Information:
Title
Pain control satisfaction assessed on the Visual Analogue Scale (VAS)
Description
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.
Time Frame
18 months
Title
Vitamin D concentration in blood, based on laboratory analysis.
Description
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.
Time Frame
18 months
Title
Efficiency of the knee joint assessed on The Knee Injury and Osteoarthritis Outcome Score (KOOS) scale.
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Calcium ionized concentration in blood, based on laboratory analysis.
Description
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.
Time Frame
18 months
Title
Total protein concentration in blood, based on laboratory analysis.
Description
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.
Time Frame
18 months
Title
Albumin concentration in blood, based on laboratory analysis
Description
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.
Time Frame
18 months
Title
C-reactive protein (CRP) concentration in blood, based on laboratory analysis
Description
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.
Time Frame
18 months
Title
Efficacy of protein supplementation assessed on the Subjective Global Assessment (SGA) scale.
Description
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.
Time Frame
18 months
Title
Efficacy of vitamin D and calcium supplementation assessed on the Simple Calculated Osteoporosis Risk Estimation (SCORE) scale.
Description
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.
Time Frame
18 months
Title
Acceptability of physical activity based on Duke Activity Status Index (DASI) scale.
Description
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.
Time Frame
18 months
Title
Incidence of cardiovascular hazard based on Cardiac Risk Index for Orthopedic Surgery (Lee) scale.
Description
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.
Time Frame
18 months
Title
Unwillingness of phisical activity due to pain based on Fear Avoidance Beliefs Questionnaire (FABQ) scale.
Description
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.
Time Frame
18 months
Title
The Quality of Life based on The Quality of Life (QOLS) scale.
Description
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.
Time Frame
18 months
Title
Incidence of Treatment-Emergent Adverse Events (AE) as assessed by frequency.
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Bartlomiej Szpyra
City
Kraków
State/Province
Malopolska
ZIP/Postal Code
31-559
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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