NCT04284423

Brief Summary

Lactate levels are rapidly available and may potentially aid in diagnosing septic arthritis in a native joint. This study will determine the utility of synovial lactate in discriminating septic from aseptic arthritis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

December 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 8, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

December 30, 2019

Last Update Submit

February 24, 2020

Conditions

Septic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Lactate level of synovial fluid

    Lactate levels of joint fluid of suspected infected knee joint. The gold standard for infected joint will be performance of washout procedure or positive gram stain or culture.

    The duration of study is one year.

Interventions

joint fluid lactateDIAGNOSTIC_TEST

Analysis of lactate level in joint fluid to determine presence of septic joint

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 21 years or older with tender swollen joints undergoing arthrocentesis will be enrolled in the study. Exclusion criteria will be overlying cellulitis, affected prosthetic joints and age under 21.

You may qualify if:

  • Age 21 and older
  • Suspected infected joint

You may not qualify if:

  • Age under 21
  • Prosthetic joint affected
  • Overlying cellulitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

RECRUITING

Related Publications (3)

  • Margaretten ME, Kohlwes J, Moore D, Bent S. Does this adult patient have septic arthritis? JAMA. 2007 Apr 4;297(13):1478-88. doi: 10.1001/jama.297.13.1478.

    PMID: 17405973BACKGROUND

  • Lenski M, Scherer MA. The significance of interleukin-6 and lactate in the synovial fluid for diagnosing native septic arthritis. Acta Orthop Belg. 2014 Mar;80(1):18-25.

    PMID: 24873080BACKGROUND

  • Carpenter CR, Schuur JD, Everett WW, Pines JM. Evidence-based diagnostics: adult septic arthritis. Acad Emerg Med. 2011 Aug;18(8):781-96. doi: 10.1111/j.1553-2712.2011.01121.x.

    PMID: 21843213BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Joint fluid

MeSH Terms

Conditions

Arthritis, Infectious

Condition Hierarchy (Ancestors)

InfectionsArthritisJoint DiseasesMusculoskeletal Diseases

Central Study Contacts

Po Y Huang, MD

CONTACT

+6583545302huangp988@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2019

First Posted

February 25, 2020

Study Start

February 8, 2020

Primary Completion

February 1, 2021

Study Completion

October 1, 2021

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)