NCT04291833

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: All
• Age: 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

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

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2020-03-02
• Last updated: 2020-03-02

Locations

1 site across 1 country: Poland