NCT04796129

Brief Summary

Osteoarthritis (OA) is a functional disease with joint degeneration with subchondral and periosteal lesions. Coxarthrosis (or hip osteoarthritis) is an important cause of disability, especially in the advanced age group.Although hip osteoarthritis is often thought to be a non-inflammatory pathology, recent studies have shown that joint degeneration is correlated with the production of inflammatory factors and cartilage destroying enzymes. There are very few studies evaluating the correlation of Neutrophil lymphocyte ratio, monocyte lymphocyte ratio and Platelet lymphocyte ratio with inflammatory parameters CRP and ESR levels in hip osteoarthritis and its relation with the staging of hip osteoatritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

February 11, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

February 10, 2021

Last Update Submit

February 17, 2022

Conditions

Keywords

hip osteoarthritisinflammationpain severitypain level

Outcome Measures

Primary Outcomes (8)

  • Visual Analog Scale

    pain of the hip joints of the participants. It will be evaluated by using Visual Analog Scale(VAS). The scale is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The pain range is from 1 to 10. The minimum value is 1 and it means the pain is so mild. The maximum value is 10, it means the pain is so much, like a knife stabs.

    1 day

  • NLR

    neutrophil lymphocyte ratio

    1day

  • PLR

    platelet lymphocyte ratio

    1 day

  • MLR

    monocyte lymphocyte ratio

    1 day

  • ESR

    Erythrocyte Sedimentation Ratio

    1 day

  • CRP

    C-reactive protein

    1 day

  • X-ray of hip joints

    an AP X-ray for the painful hip joints

    1 day

  • Lequesne Index

    pain severity

    1 day

Study Arms (2)

patients with hip osteoarthritis

the patients who aged 45 and older and have paint in the hips. and also without having any other comorbidities about inflammatory status.

Other: the patients with hip osteoarthritis and their inflammatory status

control

the participants who have any other comorbidities for impact on the inflammatory status and also no hip pain.

Other: the patients with hip osteoarthritis and their inflammatory status

Interventions

The participants in the experimental group will be evaluated for the hip osteoarthritis. They will take and X-ray for hip joints and also hemogram for the excluding the inflammatory diseases.

controlpatients with hip osteoarthritis

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

the participants in the experimental group are at aged 45 years or older and have hip osteoarthritis the participants in the control group are at aged 45 years or older and have no any other diseases that effect the inflammatory status

You may qualify if:

  • Being diagnosed with hip osteoarthritis
  • Being aged at 45 years or older

You may not qualify if:

  • Not accept being participation in the study.
  • Having any systemic disease like the diabetes mellitus, hypertension, coronary after disease
  • Having any inflammatory rheumatologic disease
  • Having any disease that prevent to participate the study like mental retardation, dementia and psychotic disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, HipInflammationPain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Merve Damla Korkmaz, 1

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 10, 2021

First Posted

March 12, 2021

Study Start

February 11, 2021

Primary Completion

November 10, 2021

Study Completion

January 10, 2022

Last Updated

February 21, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication)

Shared Documents
STUDY PROTOCOL
Time Frame
The data will be available after publication
Access Criteria
The data will share with permission and request.

Locations