RECRUITING

Effect of Therapeutic Joint Arthrocentesis on Pain and Quadriceps Function in Patients With Knee Osteoarthritis

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This will be prospective study of patients with knee effusion associated with degenerative osteoarthritis or symptomatic primary total knee arthroplasty that undergo therapeutic joint arthrocentesis. The diagnosis of knee osteoarthritis will be based on knee radiographs (including AP, Rosenburg view, lateral and Merchant views) read and interpreted by one of our clinical providers (PA, Fellow or Surgeon). Patients with at least Grade II Kellgren and Lawrence changes or higher will be included in the osteoarthritis group. Patients in the arthroplasty group must have had a primary total knee arthroplasty without infection (as determined by knee aspirate) to be included. Patients will be clinically evaluated at the time of their visit for presence of a knee effusion using a stroke test and graded on a 5-point scale (zero, trace, 1+, 2+, or 3+) which has shown good interrater reliability. Patients with a mild to severe effusion (1+ to 3+) will considered for the study. Patients having significant pain associated with their effusion will be offered a therapeutic arthrocentesis as part of their treatment plan discussion. This is a pre-post test design in which outcome measures will be collected immediately pre-arthrocentesis and immediately post arthrocentesis. Additionally, there will be an optional 7-10 follow up visit where outcomes measures will be collected again, should the participant choose to return to this visit.

Official Title

Effect of Therapeutic Joint Arthrocentesis on Pain and Quadriceps Function in Patients With Knee Osteoarthritis

Quick Facts

Study Start:2019-12-05
Study Completion:2023-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04146649

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients aged 18 years or older with mild (1+) to severe (3+) knee effusion associated with underlying osteoarthritis (Kellgren and Lawrence grade II or higher) that undergo therapeutic aspiration
  2. 2. Patients with symptomatic primary total knee arthroplasty without infection (as verified by prior aspiration) with moderate to severe effusion electing for therapeutic arthrocentesis. Must be minimum of 3 months from index surgery to be included.
  1. 1. Patients with effusion related to trauma or another underlying condition (ie. fracture, ligamentous injury, hemarthrosis)
  2. 2. Patients with known history of gout or with synovial fluid samples testing positive for urate of calcium pyrophosphate crystals
  3. 3. Patients with knee effusion associated with septic arthritis or periprosthetic knee infection as determined from knee arthrocentesis.
  4. 4. Patients with inflammatory arthritis (ie. JIA, RA, psoriatic arthritis, etc).
  5. 5. Patients with revision knee arthroplasty, unicompartmental arthroplasty or other repair/reconstruction surgery
  6. 6. Patients with underlying muscular disorder (ie. Stroke, cerebral palsy, multiple sclerosis, polymyalgia, fibromyalgia, muscular dystrophy, etc.)
  7. 7. Patients with symptomatic hip pain
  8. 8. Patients with active cancer in the area
  9. 9. Patients with pacemakers
  10. 10. Patients who are pregnant
  11. 11. Invasive or injectable therapy within the last 6 months in the involved knee, to include, but not limited to, arthrocentesis, corticosteroid, hyaluronic acid, platelet-rich plasma, prolotherapy, stem cell therapy, or genicular nerve block.
  12. 12. Blood clotting disorders, sickle cell disease or trait, or chronic anticoagulation.

Contacts and Locations

Study Contact

Rose Johnson, BS, CCRP
CONTACT
303-260-2940
roseannjohnson@centura.org

Principal Investigator

Jason Jennings, MD
PRINCIPAL_INVESTIGATOR
Colorado Joint Replacement

Study Locations (Sites)

University of Colorado Denver
Aurora, Colorado, 80045
United States
Colorado Joint Replacement
Denver, Colorado, 80210
United States

Collaborators and Investigators

Sponsor: Colorado Joint Replacement

  • Jason Jennings, MD, PRINCIPAL_INVESTIGATOR, Colorado Joint Replacement

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-05
Study Completion Date2023-12

Study Record Updates

Study Start Date2019-12-05
Study Completion Date2023-12

Terms related to this study

Additional Relevant MeSH Terms

  • Effusion Joint