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

NCT ID: NCT04487535

Last Updated: 2020-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Standard Total Knee Arthroplasty Surgery

Surgery performed by one orthopedic surgeon

Group Type OTHER

Cytokine level

Intervention Type OTHER

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

Interventions

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Cytokine level

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karadeniz Technical University

OTHER

Sponsor Role collaborator

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Kübra Canli

Karadeniz Technical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe Universty

Ankara, Sıhhıye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Karadeniz Technique Unıversty

Identifier Type: -

Identifier Source: org_study_id

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