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

NCT04487535 | Completed

• 1 other identifier: Karadeniz Technique Unıversty
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Arthroplasty

Keywords

Total knee arthroplasty; Cytokines; Proprioception; Pain; Functional Status; Lenght of Stay in hospital

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Functional Status

  Functional status will be assessed before surgery and 6 weeks after surgery

• Joint Position Sense

  It will be evaluated before surgery and 6 weeks after surgery

• X-Ray

  X-ray evaluated before surgery, 72 hour after surgery and 6 weeks ater surgery

• Serum Cytokine Level

  Venous blood sample was collected 2 weeks before surgery

Study Arms (1)

Standard Total Knee Arthroplasty Surgery

OTHER

Surgery performed by one orthopedic surgeon

Other: Cytokine level

Interventions

Cytokine level OTHER

Serum cytokine level will be measured before surgery, 72nd after surgery and 6 weeks after surgery

Standard Total Knee Arthroplasty Surgery

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• neuropathic pain
• presurgery for same lower extremity
• vascular disease
• any chronic disease related to kidney, heart, liver
• cancer
• chronic inflammatory disease

Sponsors & Collaborators

• Hacettepe University: lead
• Karadeniz Technical University: collaborator

Study Sites (1)

Hacettepe Universty

Ankara, Sıhhıye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Karadeniz Technical University

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 27, 2020
• Study Start: December 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: July 27, 2020

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)