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

NCT04146649 | Unknown

• 1 other identifier: 1415301
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Effusion Joint

Outcome Measures

Primary Outcomes (1)

• Change in quadriceps activation

  The change in quadriceps activation prior to and post arthrocentesis will be measured.

  Immediately pre aspiration (day 0), immediately post aspiration (day 0),optional 7-10 days post aspiration

Secondary Outcomes (7)

• Change in Pain

  Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration

• Function

  Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration

• Range of Motion

  Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration

• Quadriceps Strength

  Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration

• Functional Performance

  Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration

Study Arms (2)

Primary Osteoarthritis

EXPERIMENTAL

Patients with native knees and effusions will participate in this arm.

Procedure: Arthrocentesis

Primary TKA

EXPERIMENTAL

Patients with total knee replacements will participate in this arm.

Procedure: Arthrocentesis

Interventions

Arthrocentesis PROCEDURE

Patients will receive a joint arthrocentesis to remove fluid from the joint.

Primary Osteoarthritis; Primary TKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Colorado Joint Replacement: lead

Study Sites (2)

University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

Colorado Joint Replacement

Denver, Colorado, 80210, United States

RECRUITING

Related Publications (5)

• Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.

  PMID: 18163497 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6.

  PMID: 19407734 BACKGROUND

• Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1145-53. doi: 10.1016/j.joca.2013.03.018.

  PMID: 23973124 BACKGROUND

• Dieppe PA, Lohmander LS. Pathogenesis and management of pain in osteoarthritis. Lancet. 2005 Mar 12-18;365(9463):965-73. doi: 10.1016/S0140-6736(05)71086-2.

  PMID: 15766999 BACKGROUND

• Egloff C, Hugle T, Valderrabano V. Biomechanics and pathomechanisms of osteoarthritis. Swiss Med Wkly. 2012 Jul 19;142:w13583. doi: 10.4414/smw.2012.13583. eCollection 2012.

  PMID: 22815119 BACKGROUND

MeSH Terms

Conditions

Hydrarthrosis

Interventions

Arthrocentesis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jason Jennings, MD

  Colorado Joint Replacement

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rose Johnson, BS, CCRP

CONTACT

303-260-2940; roseannjohnson@centura.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 31, 2019
• Study Start: December 5, 2019
• Primary Completion: August 31, 2022
• Study Completion: December 1, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)