Total Knee Arthroplasty and Clinical Findings

NCT04481711 | Completed

• 1 other identifier: 2018-91
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis is a common disease that causes pain and loss of function. Total Knee Arthroplasty (TKA) is a frequently used surgical method in the treatment of severe knee osteoarthritis. The aim of this study was to investigate the effect of TKA on IL-6, TNF-α and IL-1β cytokine levels, pain intensity at rest and walking, knee joint valgity angle,malaligment, functional status and knee joint position sense.

Conditions

Orthopedic Disorder; Arthropathy of Knee; Pain, Joint; Proprioception; Radiography

Outcome Measures

Primary Outcomes (5)

• Proinflammatory cytokine level

  Systemic venous blood samples were taken. IL-6, TNF-α and IL-1β cytokine levels were examined.

  30 minutes

• Pain severity

  The pain intensity were evaluated by the Visuel Analog Scale.

  15 minutes

• Functional status

  The Western Ontario and McMaster Universities Arthritis Index was used for functional status.

  30 minutes

• Joint position sense

  Electro-goniometer was used for proprioception evaluation

  30 minutes

• Valgity angle and amount of malaligment

  In this evaluation, the valgity angle and the malalingement amount were calculated on the knee antero-posterior direct X-ray imageby an experienced orthopedist

  30 minutes

Study Arms (2)

Study group

EXPERIMENTAL

Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the study group. These patients underwent total knee arthroplasty

Procedure: Total Knee Arthroplasty

Control group

NO INTERVENTION

Twenty-two patients (female/male:13/9) with \<grade 4 osteoarthritis were included in the control group.

Interventions

Total Knee Arthroplasty PROCEDURE

Osteoarthritis (OA) is one of the most common chronic peripheral joint diseases increasing among the aging population.Pathogenesis is not fully known.One of the most common risk factors and causes are loss of pain and function. Knee joint osteoarthritis adversly affects the person's life quality. Total Knee Arthroplasty (TKA) is a surgical approach to restore tibiofemoral joint alignment, especially in the severe level of knee OA.

Study group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with grade 4 degeneration levels who had surgical indications between the ages of 45-75 were placed in the study group.
• Patients without surgical indication, lower than 4 OA severity included in the control group

You may not qualify if:

• Patients with surgical history of the ipsilateral side, neuropathic pain, loss of sensation, systemic, chronic and infectious disease were excluded from the study

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical Üniversitesi

Trabzon, Türkiye, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Arthralgia

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Murat Emirzeoğlu

  Karadeniz Technical University

  STUDY CHAIR

• Arzu Erden

  Karadeniz Technical University

  STUDY DIRECTOR

• Kübra Canlı

  Hacettepe University

  STUDY CHAIR

• Serap Özer Yaman

  Karadeniz Technical University

  STUDY CHAIR

• İbrahim Pekşen

  Karadeniz Technical University

  STUDY CHAIR

• Osman Aynacı

  Karadeniz Technical University

  STUDY CHAIR

• Süleyman Caner Karahan

  Karadeniz Technical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Karadeniz Technical University

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 22, 2020
• Study Start: November 8, 2018
• Primary Completion: February 8, 2020
• Study Completion: May 8, 2020
• Last Updated: July 24, 2020

Record last verified: 2020-07

Locations

TU (1)