The Relationship Between Preoperative Serum Cytokine Level and Lenght of Stay in Hospital, Postoperative Pain Intensity, Functional Status, Joint Position Sense and X Ray Findings

Serum cytokines was assosiated with symptoms and progression of osteoartritis. It is unknown whether these cytokines have a predictive role on severity of symptoms after total knee arthroplasty (TKA) or not. The aim of this study is to investigate the relationships between the preoperative serum cytokine level (SCL) and lenght of stay in hospital, postoperative pain intensity, functional status, joint position sense and X ray.

Grade 4 osteoartritis degeneration who intern the hospital for total knee arthroplasty surgery. Serum Cytokine Levels (IL-6, TNFα, IL-1β) will be assessed before surgery. Pain intensity at rest/activity and valgite angle will be evaluated before surgery, postoperative 72 hour and postoperative 6 weeks. Functional status and joint position sense will be assessed before surgery and 6 weeks after surgery. Lenght of stay in hospital (LOS) will be recorded.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Other: Cytokine level

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sıhhıye
    • Ankara, Sıhhıye, Turkey, 06100
      • Hacettepe Universty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. aged between 45-75
2. were scheduled for unilateral or bilateral TKA
3. were diagnosed of OA with a severity Grade 4 according to the Kellgren-Lawrence (KL) classification.

Exclusion Criteria:

1. neuropathic pain
2. presurgery for same lower extremity
3. vascular disease
4. any chronic disease related to kidney, heart, liver
5. cancer
6. chronic inflammatory disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Standard Total Knee Arthroplasty Surgery; Surgery performed by one orthopedic surgeon	Other: Cytokine level; Serum cytokine level will be measured before surgery, 72nd after surgery and 6 weeks after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensty	Rest and activity pain intensity will be evaluated by using 100 mm vertical line Visual Anolog Scale (VAS). Zero meet no pain, 10 unbearable pain	pain intensity will be evaluated. It will determined pain intensity alteration from 2 weeks before surgery and at 72 hours and at 6 weeks following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Status	Turkish version of Western Ontario McMaster University Osteoarthritis Index (WOMAC) scale will be used to evaluate functional status. The WOMAC is a self reported funtional assessment scale consisting of 24 items which responded on Likert type scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme), with higher score indicating more difficulty	Functional status will be assessed before surgery and 6 weeks after surgery
Joint Position Sense	Joint positon sense will be evaluated by using a digital goniometer. Each patient will be asked to sat in a erect pack position on the chair with knee relaxed in 90 º flexion noticing that popliteal fossa was not in contact with end edge of the chair. A digital goniometer will be placed at the lateral aspect of the knee, with moveable arm in the course of midline of the lateral malleolus and stationary arm along the midline of the femur. The knee will be moved passively by examiner slowly from initial position (90º flexion) to final predetermined three angle (35º, 55º, 70º), hold final positon for 5 second and then return to initial position with same speed. After instruction the procedure, patients will be ask to extend the knee actively for each angle. This procedure will be repeated three times for each angle.	It will be evaluated before surgery and 6 weeks after surgery
X-Ray	To measure valgus angle, standart anteroposterior (AP) X ray view was obtained from patients in standing position and without shoes. The angle between femoral axis which indicate a line drawn from femoral head to femoral intercondylar notch and tibial axis which describe a line from the center of the talus bone to the center of the tibial spine was measured by orthopedics	X-ray evaluated before surgery, 72 hour after surgery and 6 weeks ater surgery
Serum Cytokine Level	Five-milliliter blood samples from each individual were placed into vacutainer tubes without anticoagulant. These were then centrifuged at 1800 g for 10 minutes. Serum samples were stored at -80°C until being used for measurements. Serum IL- 6, TNF-α ve IL-1β levels were determined using commercial sandwich-ELISA kits. The absorbance of the samples was measured at a 450 nm wavelength on a VERSA (designed by Molecular Devices in California, USA) micro plate reader. The results were expressed as pg/ mL. The coefficients of variation (CV) of this ELISA method were6.69% for IL-6, 6.62% for TNF alfa and 6.72% for IL-1beta.	Venous blood sample was collected 2 weeks before surgery

Collaborators and Investigators

• Sponsor: Hacettepe University
• Collaborators: Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2018
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): February 1, 2020

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (ACTUAL): July 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Pain; Total knee arthroplasty; Cytokines; Proprioception; Functional Status; Lenght of Stay in hospital
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Neurologic Manifestations; Pain, Postoperative; Pain
• Other Study ID Numbers: Karadeniz Technique Unıversty

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No