Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04146649
Recruitment Status : Not yet recruiting
First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Jason Jennings, Colorado Joint Replacement

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 Outerbridge 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 bulge test and graded on a 4-point scale (none, mild, moderate, severe) which has shown good interobserver reliability (reliability coefficient = 0.97)23. Patients with a moderate or severe effusion will be included in the study. Patients with no or only mild effusion will not be included due to the increased risk for a dry tap or minimally effective fluid volume reduction with arthrocentesis. Patients having significant pain associated with their effusion will be offered a therapeutic arthrocentesis as part of their treatment plan discussion.

Condition or disease Intervention/treatment Phase
Effusion Joint Procedure: Arthrocentesis Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Therapeutic Joint Arthrocentesis on Pain and Quadriceps Function in Patients With Knee Osteoarthritis
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Primary Osteoarthritis
Patients with native knees and effusions will participate in this arm.
Procedure: Arthrocentesis
Patients will receive a joint arthrocentesis to remove fluid from the joint.

Experimental: Primary TKA
Patients with total knee replacements will participate in this arm.
Procedure: Arthrocentesis
Patients will receive a joint arthrocentesis to remove fluid from the joint.




Primary Outcome Measures :
  1. Change in quadriceps activation [ Time Frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), 7-10 days post aspiration ]
    The change in quadriceps activation prior to and post arthrocentesis will be measured.


Secondary Outcome Measures :
  1. Change in Pain [ Time Frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), 7-10 days post aspiration ]
    Self reported pain scores

  2. Function [ Time Frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), 7-10 days post aspiration ]
    Self reported function will be collected

  3. Range of Motion [ Time Frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), 7-10 days post aspiration ]
    Range of motion will be measured

  4. Quadriceps Strength [ Time Frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), 7-10 days post aspiration ]
    This will be measured using the Humac Norm chair

  5. Functional Performance [ Time Frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), 7-10 days post aspiration ]
    This will be assessed with standardized functional tests (30 STS, TUG)

  6. Volume of Knee Synovial Fluid Aspirated [ Time Frame: Immediately post aspiration (day 0) ]
    We will look at the volume of fluid drawn off the knee

  7. Bioelectrical Impedance [ Time Frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), 7-10 days post aspiration ]
    This will be measured with The RJL Systems Quantum®



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients aged 18 years or older with moderate to severe knee effusion associated with underlying osteoarthritis (Outerbridge grade II or higher) that undergo therapeutic aspiration
  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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146649


Locations
Layout table for location information
United States, Colorado
Colorado Joint Replacement Not yet recruiting
Denver, Colorado, United States, 80210
Contact: Roseann Johnson    303-260-2940    RoseannJohnson@centura.org   
Principal Investigator: Jason Jennings, MD         
Sub-Investigator: Douglas Dennis, MD         
Sub-Investigator: Lindsay Kleeman, MD         
Sub-Investigator: Jennifer Steven-Lapsley, MPT,PhD         
Sub-Investigator: Michael Bade, DPT         
Sub-Investigator: Joel Carmichael, DPT         
Sponsors and Collaborators
Colorado Joint Replacement

Publications:
Layout table for additonal information
Responsible Party: Jason Jennings, Primary Investigator, Colorado Joint Replacement
ClinicalTrials.gov Identifier: NCT04146649     History of Changes
Other Study ID Numbers: 1415301
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases