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Total Knee ArthroplastyNCT04487535

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

A study testing Cytokine level in people with Total Knee Arthroplasty, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Total Knee Arthroplasty
What is being tested?
Cytokine level
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2018to 1 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Hacettepe Universty

    Ankara, Sıhhıye, 06100

Other trials in Turkey (Türkiye)

About this study

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.

Being tested
Cytokine level
Keywords
Total knee arthroplasty, Cytokines, Proprioception, Pain, Functional Status, Lenght of Stay in hospital
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cytokine levelOther

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

Study groups in NCT04487535
Study groupRoleWhat they receive
Standard Total Knee Arthroplasty SurgeryOtherSurgery performed by one orthopedic surgeon
Receives: Other: Cytokine level

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. 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

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

  2. 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.

    Measured: It will be evaluated before surgery and 6 weeks after surgery

  3. 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

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

  4. 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.

    Measured: Venous blood sample was collected 2 weeks before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2020
  2. Study start1 Dec 2018
  3. Primary completion1 Jan 2020
  4. Study completion1 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04487535
Sponsor's protocol ID
Karadeniz Technique Unıversty
Status last verified
Jan 2018
First submitted
16 Jul 2020
Last updated
27 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cytokine level in people with Total Knee Arthroplasty, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensty (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04487535.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.

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