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

Jagiellonian University

Status: Completed

Conditions: Vitamin D Deficiency; Pain, Postoperative; Knee Osteoarthritis; Arthropathy of Knee

Treatments: Behavioral: Intervention group 1; Behavioral: Control group 0; Behavioral: Intervention group 2

Study type: Interventional

Funder types: Other

Identifiers

NCT04291833

KBET/271/B/2014

Details and patient eligibility

About

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).

Enrollment: 150 patients

Sex: All

Ages: Under 85 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups, including a placebo group

Intervention group 1

Active Comparator group

Description:

Protein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months

Treatment:

Behavioral: Intervention group 1

Intervention group 2

Active Comparator group

Description:

Protein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months

Treatment:

Behavioral: Intervention group 2

Control group 0

Placebo Comparator group

Description:

no protein supplementation , no Vitamin D and calcium supplementation , no exercise

Treatment:

Behavioral: Control group 0