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

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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

Tracking Information
First Submitted Date  ICMJE October 28, 2019
First Posted Date  ICMJE October 31, 2019
Last Update Posted Date October 31, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
  • Change in Pain [ Time Frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), 7-10 days post aspiration ]
    Self reported pain scores
  • Function [ Time Frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), 7-10 days post aspiration ]
    Self reported function will be collected
  • 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
  • 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
  • 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)
  • 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
  • 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®
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Therapeutic Joint Arthrocentesis on Pain and Quadriceps Function in Patients With Knee Osteoarthritis
Official Title  ICMJE Effect of Therapeutic Joint Arthrocentesis on Pain and Quadriceps Function in Patients With Knee Osteoarthritis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Effusion Joint
Intervention  ICMJE Procedure: Arthrocentesis
Patients will receive a joint arthrocentesis to remove fluid from the joint.
Study Arms  ICMJE
  • Experimental: Primary Osteoarthritis
    Patients with native knees and effusions will participate in this arm.
    Intervention: Procedure: Arthrocentesis
  • Experimental: Primary TKA
    Patients with total knee replacements will participate in this arm.
    Intervention: Procedure: Arthrocentesis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 29, 2019)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04146649
Other Study ID Numbers  ICMJE 1415301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jason Jennings, Colorado Joint Replacement
Study Sponsor  ICMJE Colorado Joint Replacement
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Colorado Joint Replacement
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP