drugset / Trial / NCT04261049
Effect of Zilretta Injection
Phase 1
Completed
35 enrolled
University of North Carolina, Chapel Hill
Pacira Pharmaceuticals, Inc · collab
NaSingle-groupOpen-labelBasic science
Summary
The purpose of this study is to examine the pre-post effects of a single ZILRETTA knee injection on physiological measures of self-reported pain and disability, physical performance, and physical activity in individuals with knee osteoarthritis (OA). The investigators will recruit 35 symptomatic knee OA patients for this study. All data will be collected prior to injection (baseline), as well as at 4 (post 1) and 8-week follow-ups (post 2).
Timeline
- Start
- 2020-08-01
- Primary completion
- 2022-01-10
- Completion
- 2022-01-10
Publications
- Background Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
- Background Elliott P, Hawthorne G. Imputing missing repeated measures data: how should we proceed? Aust N Z J Psychiatry. 2005 Jul;39(7):575-82. doi: 10.1080/j.1440-1614.2005.01629.x.
- Background Harkey MS, Gribble PA, Pietrosimone BG. Disinhibitory interventions and voluntary quadriceps activation: a systematic review. J Athl Train. 2014 May-Jun;49(3):411-21. doi: 10.4085/1062-6050-49.1.04. Epub 2014 Feb 3.
- Background Hopkins JT, Ingersoll CD, Edwards JE, Cordova ML. Changes in soleus motoneuron pool excitability after artificial knee joint effusion. Arch Phys Med Rehabil. 2000 Sep;81(9):1199-203. doi: 10.1053/apmr.2000.6298.
- Background Hopkins J, Ingersoll CD, Edwards J, Klootwyk TE. Cryotherapy and Transcutaneous Electric Neuromuscular Stimulation Decrease Arthrogenic Muscle Inhibition of the Vastus Medialis After Knee Joint Effusion. J Athl Train. 2002 Mar;37(1):25-31.
- Background Hopkins JT, Ingersoll CD, Krause BA, Edwards JE, Cordova ML. Effect of knee joint effusion on quadriceps and soleus motoneuron pool excitability. Med Sci Sports Exerc. 2001 Jan;33(1):123-6. doi: 10.1097/00005768-200101000-00019.
- Background Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
- Background KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
- Background Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005 Jan 28;6:3. doi: 10.1186/1471-2474-6-3.
- Background Lewek M, Rudolph K, Axe M, Snyder-Mackler L. The effect of insufficient quadriceps strength on gait after anterior cruciate ligament reconstruction. Clin Biomech (Bristol). 2002 Jan;17(1):56-63. doi: 10.1016/s0268-0033(01)00097-3.
- Background Leyland KM, Gates LS, Sanchez-Santos MT, Prieto Alhambra D, Judge A, Collins G, Cleveland R, Felson D, Jordon JM, Callahan LF, Nevitt M, Saberi Hosnijeh F, van Meurs JB, Jones G, Newton J, Batt M, Altman D, Cooper C, Arden N, Committee PC. Knee osteoarthritis and the risk of premature mortality in the community: an international individual patient level meta-analysis in 9889 subjects. Osteoarthritis and Cartilage. 2017;25:S29-S30.
- Background Liikavainio T, Isolehto J, Helminen HJ, Perttunen J, Lepola V, Kiviranta I, Arokoski JP, Komi PV. Loading and gait symmetry during level and stair walking in asymptomatic subjects with knee osteoarthritis: importance of quadriceps femoris in reducing impact force during heel strike? Knee. 2007 Jun;14(3):231-8. doi: 10.1016/j.knee.2007.03.001. Epub 2007 Apr 23.
- Background Liikavainio T, Lyytinen T, Tyrvainen E, Sipila S, Arokoski JP. Physical function and properties of quadriceps femoris muscle in men with knee osteoarthritis. Arch Phys Med Rehabil. 2008 Nov;89(11):2185-94. doi: 10.1016/j.apmr.2008.04.012.
- Background Luc BA, Lepley AS, Tevald MA, Gribble PA, White DB, Pietrosimone BG. Reliability of corticomotor excitability in leg and thigh musculature at 14 and 28 days. J Sport Rehabil. 2014 Nov;23(4):330-8. doi: 10.1123/jsr.2013-0069. Epub 2013 Oct 1.
- Background Luc BA, Harkey MH, Arguelles GD, Blackburn JT, Ryan ED, Pietrosimone B. Measuring voluntary quadriceps activation: Effect of visual feedback and stimulus delivery. J Electromyogr Kinesiol. 2016 Feb;26:73-81. doi: 10.1016/j.jelekin.2015.10.006. Epub 2015 Nov 2.
- Background Luc-Harkey BA, Blackburn JT, Ryan ED, Harkey MS, Davis HC, Gaynor BR, Nissman DB, Spang JT, Pietrosimone B. Quadriceps Rate of Torque Development and Disability in Persons With Tibiofemoral Osteoarthritis. J Orthop Sports Phys Ther. 2018 Sep;48(9):694-703. doi: 10.2519/jospt.2018.7898. Epub 2018 May 22.
- Background Marcus BH, Selby VC, Niaura RS, Rossi JS. Self-efficacy and the stages of exercise behavior change. Res Q Exerc Sport. 1992 Mar;63(1):60-6. doi: 10.1080/02701367.1992.10607557.
- Background Nuesch E, Dieppe P, Reichenbach S, Williams S, Iff S, Juni P. All cause and disease specific mortality in patients with knee or hip osteoarthritis: population based cohort study. BMJ. 2011 Mar 8;342:d1165. doi: 10.1136/bmj.d1165.
- Background Palmieri-Smith RM, Thomas AC. A neuromuscular mechanism of posttraumatic osteoarthritis associated with ACL injury. Exerc Sport Sci Rev. 2009 Jul;37(3):147-53. doi: 10.1097/JES.0b013e3181aa6669.
- Background Pietrosimone B, Lepley AS, Murray AM, Thomas AC, Bahhur NO, Schwartz TA. Changes in voluntary quadriceps activation predict changes in muscle strength and gait biomechanics following knee joint effusion. Clin Biomech (Bristol). 2014 Sep;29(8):923-9. doi: 10.1016/j.clinbiomech.2014.06.014. Epub 2014 Jul 4.
- Background Pietrosimone BG, McLeod MM, Lepley AS. A theoretical framework for understanding neuromuscular response to lower extremity joint injury. Sports Health. 2012 Jan;4(1):31-5. doi: 10.1177/1941738111428251.
- Background Pietrosimone B, Thomas AC, Saliba SA, Ingersoll CD. Association between quadriceps strength and self-reported physical activity in people with knee osteoarthritis. Int J Sports Phys Ther. 2014 May;9(3):320-8.
- Background Pietrosimone BG, Hertel J, Ingersoll CD, Hart JM, Saliba SA. Voluntary quadriceps activation deficits in patients with tibiofemoral osteoarthritis: a meta-analysis. PM R. 2011 Feb;3(2):153-62; quiz 162. doi: 10.1016/j.pmrj.2010.07.485.
- Background Pietrosimone BG, Saliba SA. Changes in voluntary quadriceps activation predict changes in quadriceps strength after therapeutic exercise in patients with knee osteoarthritis. Knee. 2012 Dec;19(6):939-43. doi: 10.1016/j.knee.2012.03.002. Epub 2012 Apr 13.
- Background Pietrosimone BG, Saliba SA, Hart JM, Hertel J, Kerrigan DC, Ingersoll CD. Effects of disinhibitory transcutaneous electrical nerve stimulation and therapeutic exercise on sagittal plane peak knee kinematics and kinetics in people with knee osteoarthritis during gait: a randomized controlled trial. Clin Rehabil. 2010 Dec;24(12):1091-101. doi: 10.1177/0269215510375903. Epub 2010 Aug 16.
- Background Roos EM, Klassbo M, Lohmander LS. WOMAC osteoarthritis index. Reliability, validity, and responsiveness in patients with arthroscopically assessed osteoarthritis. Western Ontario and MacMaster Universities. Scand J Rheumatol. 1999;28(4):210-5. doi: 10.1080/03009749950155562.
- Background Seeley MK, Park J, King D, Hopkins JT. A novel experimental knee-pain model affects perceived pain and movement biomechanics. J Athl Train. 2013 May-Jun;48(3):337-45. doi: 10.4085/1062-6050-48.2.02. Epub 2013 Feb 20.
- Background Simonsick EM, Gardner AW, Poehlman ET. Assessment of physical function and exercise tolerance in older adults: reproducibility and comparability of five measures. Aging (Milano). 2000 Aug;12(4):274-80. doi: 10.1007/BF03339847.
- Background Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Ann Rheum Dis. 2005 Jan;64(1):34-7. doi: 10.1136/ard.2004.023028. Epub 2004 May 6.
- Background Washburn RA, Smith KW, Jette AM, Janney CA. The Physical Activity Scale for the Elderly (PASE): development and evaluation. J Clin Epidemiol. 1993 Feb;46(2):153-62. doi: 10.1016/0895-4356(93)90053-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Triamcinolone Acetonide | Other / unclassified | 32 mg | Other |