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

Primary Purpose

Effusion Joint

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arthrocentesis
Sponsored by
Colorado Joint Replacement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effusion Joint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  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. 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
  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. Blood clotting disorders, sickle cell disease or trait, or chronic anticoagulation.

Sites / Locations

  • University of Colorado DenverRecruiting
  • Colorado Joint ReplacementRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Primary Osteoarthritis

Primary TKA

Arm Description

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

Patients with total knee replacements will participate in this arm.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Pain
Self reported pain scores
Function
Self reported function will be collected
Range of Motion
Range of motion will be measured
Quadriceps Strength
This will be measured using the Humac Norm chair
Functional Performance
This will be assessed with standardized functional tests (30 STS, TUG)
Volume of Knee Synovial Fluid Aspirated
We will look at the volume of fluid drawn off the knee
Bioelectrical Impedance
This will be measured with The RJL Systems Quantum®

Full Information

First Posted
October 28, 2019
Last Updated
August 29, 2023
Sponsor
Colorado Joint Replacement
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1. Study Identification

Unique Protocol Identification Number
NCT04146649
Brief Title
Effect of Therapeutic Joint Arthrocentesis on Pain and Quadriceps Function in Patients With Knee Osteoarthritis
Official Title
Effect of Therapeutic Joint Arthrocentesis on Pain and Quadriceps Function in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado Joint Replacement

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Pain and Self-Reported Function Knee pain will be assessed with an 11-point numeric pain rating scale (NPRS) where 0 represents 'no pain' and 10 represents 'worst imaginable pain'. Self-reported physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for each knee separately. The WOMAC assesses the impact of knee osteoarthritis on multiple domains-pain, stiffness, and disability. A composite score (0-100 scale) will be used for analysis. Range of Motion Knee range of motion (ROM) is a direct measure of joint mobility following TKA. Knee ROM will be measured in the supine position both actively and passively using a long-arm goniometer. Goniometry has been shown to be a reliable measure of knee ROM after TKA. Quadriceps Strength and Activation Testing Maximum voluntary isometric quadriceps strength and quadriceps activation will be assessed before surgery and at week 3 using an electromechanical dynamometer (Humac Norm, CSMI) and a doublet interpolation test. Patients will be seated on the electromechanical dynamometer with their hips flexed to approximately 85° and their knees flexed to 60°. Two 3" by 5" self-adhesive neuromuscular stimulation electrodes will be placed over the motor points of the rectus femoris and the vastus medialis. A Grass S48 stimulator with a Grass Model SIU8T stimulus isolation unit will be used to deliver 600 µs doublet pulses. A Biopac MP150WSW system will be used for data acquisition during testing with sampling frequency of 300 Hz. Following two warm-up contractions, a practice maximal voluntary isometric contraction (MVIC) will be performed against the dynamometer's force transducer. Visual torque targets will be set on the feedback monitor at slightly higher torques than produced during the practice MVIC trial. Trials will be repeated until maximal torque is within 5% of the previous attempt. Torque from quadriceps MVIC will be normalized to body weight for between-subject comparisons. Voluntary activation of the quadriceps muscle will be assessed using the doublet interpolation technique, where a supramaximal stimulus will be applied by a Grass S48 stimulator during an MVIC and immediately afterwards while the quadriceps muscle is at rest. Normalization of the force from the superimposed doublet to the resting doublet allows for comparisons of quadriceps activation across individuals and lower extremities. Timed-Up-and-Go The timed-up-and-go (TUG) test is a responsive, valid, and reliable functional measure of basic mobility and dynamic balance. The examiner measures the time, in seconds, required by the patient to a) rise from an arm chair; b) walk 3 meters; c) turn and walk back to the arm chair; and d) return to the seated position. 30-second Sit-to-Stand Test The 30-second Sit-to-Stand test (30STS) is a responsive, valid, and reliable functional measure of lower extremity strength after TKA. This test counts the number of times a patient can rise to a full standing position in 30 seconds. The test starting position is sitting on an armless chair with seat plate 17 inches from the floor. Patients rise from this position with hands placed on opposite shoulders. If the patient must use his/her arms to stand, the test is stopped. If the patient is over halfway to a standing position when 30 seconds have lapsed, this counts as a stand. Bioimpedance Spectroscopy Bioimpedance spectroscopy (BIS) is a reliable, responsive measure of swelling that has been validated in observational studies of individuals after TKA. The RJL Systems Quantum® (Clinton Township, MI) bioelectrical impedance device delivers a 2.5 µA alternating current at a frequency of 50 kHz. The tissue impedance to this current is displayed in Ohms (Ω) and is recorded at a precision of 1 Ω. The level of impedance met by the current reflects the composition of the tissue, but will also fluctuate with the presence of swelling in the lower extremity. Lower levels of impedance represent the increased fluid content present with greater levels of swelling. Measuring the impedance of both the involved and uninvolved limb allows for calculation of a ratio (W-involved limb: W-uninvolved limb). To measure impedance, a four-wire measurement method will be used. The most proximal electrode pair will be placed 10 and 20 centimeters above the superior patellar pole. The most distal electrode pair will be placed at a point bisecting the medial and lateral malleolus, and also 10 cm distal to that point along the second ray of the foot. New electrodes will be used for each testing session, and skin will be cleaned with an alcohol swab prior to electrode placement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effusion Joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary Osteoarthritis
Arm Type
Experimental
Arm Description
Patients with native knees and effusions will participate in this arm.
Arm Title
Primary TKA
Arm Type
Experimental
Arm Description
Patients with total knee replacements will participate in this arm.
Intervention Type
Procedure
Intervention Name(s)
Arthrocentesis
Intervention Description
Patients will receive a joint arthrocentesis to remove fluid from the joint.
Primary Outcome Measure Information:
Title
Change in quadriceps activation
Description
The change in quadriceps activation prior to and post arthrocentesis will be measured.
Time Frame
Immediately pre aspiration (day 0), immediately post aspiration (day 0),optional 7-10 days post aspiration
Secondary Outcome Measure Information:
Title
Change in Pain
Description
Self reported pain scores
Time Frame
Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Title
Function
Description
Self reported function will be collected
Time Frame
Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Title
Range of Motion
Description
Range of motion will be measured
Time Frame
Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Title
Quadriceps Strength
Description
This will be measured using the Humac Norm chair
Time Frame
Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Title
Functional Performance
Description
This will be assessed with standardized functional tests (30 STS, TUG)
Time Frame
Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Title
Volume of Knee Synovial Fluid Aspirated
Description
We will look at the volume of fluid drawn off the knee
Time Frame
Immediately post aspiration (day 0)
Title
Bioelectrical Impedance
Description
This will be measured with The RJL Systems Quantum®
Time Frame
Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rose Johnson, BS, CCRP
Phone
303-260-2940
Email
roseannjohnson@centura.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Jennings, MD
Organizational Affiliation
Colorado Joint Replacement
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Bade, PT, DPT, PhD
Phone
719-251-7533
Email
maggie.givan@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
Andrea Marshall, PT, DPT
First Name & Middle Initial & Last Name & Degree
Craig Hogan, MD
First Name & Middle Initial & Last Name & Degree
Michael Dayton, MD
Facility Name
Colorado Joint Replacement
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roseann Johnson
Phone
303-260-2940
Email
RoseannJohnson@centura.org
First Name & Middle Initial & Last Name & Degree
Jason Jennings, MD
First Name & Middle Initial & Last Name & Degree
Douglas Dennis, MD
First Name & Middle Initial & Last Name & Degree
Lindsay Kleeman, MD
First Name & Middle Initial & Last Name & Degree
Jennifer Steven-Lapsley, MPT,PhD
First Name & Middle Initial & Last Name & Degree
Michael Bade, DPT
First Name & Middle Initial & Last Name & Degree
Joel Carmichael, DPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18163497
Citation
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.
Results Reference
background
PubMed Identifier
19407734
Citation
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.
Results Reference
background
PubMed Identifier
23973124
Citation
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.
Results Reference
background
PubMed Identifier
15766999
Citation
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.
Results Reference
background
PubMed Identifier
22815119
Citation
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.
Results Reference
background

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

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