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

Status unconfirmed · Not applicable

Conditions studied: Effusion Joint

In brief

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.

Key facts

Study ID: NCT04146649
Run by: Colorado Joint Replacement
People needed: 66
Starts: 2019-12-05
Expected to finish: 2023-12-01
Last updated by the study team: 2023-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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
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.

You may not qualify if…

Patients with effusion related to trauma or another underlying condition (ie. fracture, ligamentous injury, hemarthrosis)
Patients with known history of gout or with synovial fluid samples testing positive for urate of calcium pyrophosphate crystals
Patients with knee effusion associated with septic arthritis or periprosthetic knee infection as determined from knee arthrocentesis.
Patients with inflammatory arthritis (ie. JIA, RA, psoriatic arthritis, etc).
Patients with revision knee arthroplasty, unicompartmental arthroplasty or other repair/reconstruction surgery
Patients with underlying muscular disorder (ie. Stroke, cerebral palsy, multiple sclerosis, polymyalgia, fibromyalgia, muscular dystrophy, etc.)
Patients with symptomatic hip pain
Patients with active cancer in the area
Patients with pacemakers
Patients who are pregnant
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.
Blood clotting disorders, sickle cell disease or trait, or chronic anticoagulation.

Where it is running

University of Colorado Denver — Aurora, Colorado, United States (enrolling)
Colorado Joint Replacement — Denver, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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