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79% participant retention after 1 year
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| Name | Class |
|---|---|
| American Orthopaedic Society for Sports Medicine | OTHER |
| University of Washington | OTHER |
| Rizzoli Orthopaedic Institute | UNKNOWN |
| Norwegian Olympic Sports Center |
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This is a randomized controlled clinical trial to investigate the effectiveness, safety and tolerability of platelet-rich plasma (PRP) injections for treatment of patellar tendinopathy in adults 18-50 years of age. Subjects will be randomly assigned to three parallel treatment groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leukocyte-rich Platelet Rish Plasma + exercise | Experimental | Leukocyte-rich PRP injection and a 12 week exercise program. |
|
| Leukocyte-poor Platelet Rich Plasma + exercise | Experimental | Leukocyte-poor PRP injection and a 12 week exercise program. |
|
| Saline + exercise | Placebo Comparator | Saline injection and a 12 week exercise program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma (PRP) | Biological | Injection of Leukocyte-rich or Leukocyte-poor Platelet Rich Plasma prepared by the Angel cPRP System along with a 12 week exercise program for treatment of patients with patellar tendinopathy. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Efficacy | Number and frequency of adverse events will be assessed/reported weekly for the first 12 weeks and at the 6 month visit. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in function over time measured by VISA Score | To compare change in function (VISA score) between participants randomized to the three treatment groups over six months, 1 year, and 2 years of a post-injection exercise protocol. | 2 years |
| Comparison of treatment success measured by Likert Global Improvement Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Scott, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Steadman Clinic | Vail | Colorado | 81657 | United States | ||
| University of Washington |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15722279 | Background | Lian OB, Engebretsen L, Bahr R. Prevalence of jumper's knee among elite athletes from different sports: a cross-sectional study. Am J Sports Med. 2005 Apr;33(4):561-7. doi: 10.1177/0363546504270454. Epub 2005 Feb 8. | |
| 3738327 | Background | Ferretti A. Epidemiology of jumper's knee. Sports Med. 1986 Jul-Aug;3(4):289-95. doi: 10.2165/00007256-198603040-00005. |
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| ID | Term |
|---|---|
| D011203 | Poverty |
| D012965 | Sodium Chloride |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
Not provided
Not provided
| UNKNOWN |
| University of Oslo | OTHER |
| Steadman Clinic | UNKNOWN |
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|
| Saline + exercise | Other | Peritendinous saline injection plus 12 week exercise program. |
|
To compare change in treatment success (Likert global improvement scale) between participants randomized to the three treatment groups over six months, 1 year, and 2 years of a post-injection exercise protocol. |
| 2 years |
| Change in activity levels over time measured by Tegner Activity Score | To compare change in activity levels (Tegner Activity Score) between participants randomized to the three groups over six months, 1 year, and 2 years of an exercise protocol. | 2 years |
| Change in activity-related pain over time measured by Pain Numeric Rating Scale | To compare change in activity-related pain (Pain Numeric Rating Scale) between participants randomized to the three groups over six months, 1 year, and 2 years of an exercise protocol. | 2 years |
| Seattle |
| Washington |
| 98195 |
| United States |
| University of Britich Columbia | Vancouver | British Columbia | V6T 1Z4 | Canada |
| Rizzoli Orthopaedic Institute | Bologna | Italy |
| Oslo Sports Trauma Research Center | Oslo | Norway |
| 8734892 | Background | Lian O, Engebretsen L, Ovrebo RV, Bahr R. Characteristics of the leg extensors in male volleyball players with jumper's knee. Am J Sports Med. 1996 May-Jun;24(3):380-5. doi: 10.1177/036354659602400322. |
| 21106774 | Background | Engebretsen L, Steffen K, Alsousou J, Anitua E, Bachl N, Devilee R, Everts P, Hamilton B, Huard J, Jenoure P, Kelberine F, Kon E, Maffulli N, Matheson G, Mei-Dan O, Menetrey J, Philippon M, Randelli P, Schamasch P, Schwellnus M, Vernec A, Verrall G. IOC consensus paper on the use of platelet-rich plasma in sports medicine. Br J Sports Med. 2010 Dec;44(15):1072-81. doi: 10.1136/bjsm.2010.079822. No abstract available. |
| Background | Scott, A, KM Khan, J Cook, and V Duronio, Human tendon overuse pathology: histopathologic and biochemical findings, in Tendinopathy in Athletes, S.L. Woo, S.P. Arnoczky, and P. Renstrom, Editors. 2007, Blackwell Publishing Ltd: Malden, Massachusetts. p. 69-84. |
| 20154324 | Background | Kongsgaard M, Qvortrup K, Larsen J, Aagaard P, Doessing S, Hansen P, Kjaer M, Magnusson SP. Fibril morphology and tendon mechanical properties in patellar tendinopathy: effects of heavy slow resistance training. Am J Sports Med. 2010 Apr;38(4):749-56. doi: 10.1177/0363546509350915. Epub 2010 Feb 12. |
| 22186923 | Background | Larsson ME, Kall I, Nilsson-Helander K. Treatment of patellar tendinopathy--a systematic review of randomized controlled trials. Knee Surg Sports Traumatol Arthrosc. 2012 Aug;20(8):1632-46. doi: 10.1007/s00167-011-1825-1. Epub 2011 Dec 21. |
| 16882889 | Background | Bahr R, Fossan B, Loken S, Engebretsen L. Surgical treatment compared with eccentric training for patellar tendinopathy (Jumper's Knee). A randomized, controlled trial. J Bone Joint Surg Am. 2006 Aug;88(8):1689-98. doi: 10.2106/JBJS.E.01181. |
| 18270224 | Background | Warden SJ, Metcalf BR, Kiss ZS, Cook JL, Purdam CR, Bennell KL, Crossley KM. Low-intensity pulsed ultrasound for chronic patellar tendinopathy: a randomized, double-blind, placebo-controlled trial. Rheumatology (Oxford). 2008 Apr;47(4):467-71. doi: 10.1093/rheumatology/kem384. Epub 2008 Feb 12. |
| 19793213 | Background | Kongsgaard M, Kovanen V, Aagaard P, Doessing S, Hansen P, Laursen AH, Kaldau NC, Kjaer M, Magnusson SP. Corticosteroid injections, eccentric decline squat training and heavy slow resistance training in patellar tendinopathy. Scand J Med Sci Sports. 2009 Dec;19(6):790-802. doi: 10.1111/j.1600-0838.2009.00949.x. Epub 2009 May 28. |
| 19188560 | Background | Rees JD, Maffulli N, Cook J. Management of tendinopathy. Am J Sports Med. 2009 Sep;37(9):1855-67. doi: 10.1177/0363546508324283. Epub 2009 Feb 2. |
| 21543346 | Background | van Ark M, Zwerver J, van den Akker-Scheek I. Injection treatments for patellar tendinopathy. Br J Sports Med. 2011 Oct;45(13):1068-76. doi: 10.1136/bjsm.2010.078824. Epub 2011 May 3. |
| 19641918 | Background | Filardo G, Kon E, Della Villa S, Vincentelli F, Fornasari PM, Marcacci M. Use of platelet-rich plasma for the treatment of refractory jumper's knee. Int Orthop. 2010 Aug;34(6):909-15. doi: 10.1007/s00264-009-0845-7. Epub 2009 Jul 31. |
| 19380129 | Background | Kon E, Filardo G, Delcogliano M, Presti ML, Russo A, Bondi A, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma: new clinical application: a pilot study for treatment of jumper's knee. Injury. 2009 Jun;40(6):598-603. doi: 10.1016/j.injury.2008.11.026. Epub 2009 Apr 19. |
| 16920768 | Background | Banfi G, Corsi MM, Volpi P. Could platelet rich plasma have effects on systemic circulating growth factors and cytokine release in orthopaedic applications? Br J Sports Med. 2006 Oct;40(10):816. doi: 10.1136/bjsm.2006.029934. Epub 2006 Aug 18. No abstract available. |
| 22241606 | Background | Sheth U, Simunovic N, Klein G, Fu F, Einhorn TA, Schemitsch E, Ayeni OR, Bhandari M. Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis. J Bone Joint Surg Am. 2012 Feb 15;94(4):298-307. doi: 10.2106/JBJS.K.00154. |
| 21813443 | Background | Thanasas C, Papadimitriou G, Charalambidis C, Paraskevopoulos I, Papanikolaou A. Platelet-rich plasma versus autologous whole blood for the treatment of chronic lateral elbow epicondylitis: a randomized controlled clinical trial. Am J Sports Med. 2011 Oct;39(10):2130-4. doi: 10.1177/0363546511417113. Epub 2011 Aug 2. |
| 21051428 | Background | Castillo TN, Pouliot MA, Kim HJ, Dragoo JL. Comparison of growth factor and platelet concentration from commercial platelet-rich plasma separation systems. Am J Sports Med. 2011 Feb;39(2):266-71. doi: 10.1177/0363546510387517. Epub 2010 Nov 4. |
| 22495144 | Background | Dragoo JL, Braun HJ, Durham JL, Ridley BA, Odegaard JI, Luong R, Arnoczky SP. Comparison of the acute inflammatory response of two commercial platelet-rich plasma systems in healthy rabbit tendons. Am J Sports Med. 2012 Jun;40(6):1274-81. doi: 10.1177/0363546512442334. Epub 2012 Apr 10. |
| 15621359 | Background | Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available. |
| 19307332 | Background | Briggs KK, Steadman JR, Hay CJ, Hines SL. Lysholm score and Tegner activity level in individuals with normal knees. Am J Sports Med. 2009 May;37(5):898-901. doi: 10.1177/0363546508330149. Epub 2009 Mar 23. |
| 31038979 | Derived | Scott A, LaPrade RF, Harmon KG, Filardo G, Kon E, Della Villa S, Bahr R, Moksnes H, Torgalsen T, Lee J, Dragoo JL, Engebretsen L. Platelet-Rich Plasma for Patellar Tendinopathy: A Randomized Controlled Trial of Leukocyte-Rich PRP or Leukocyte-Poor PRP Versus Saline. Am J Sports Med. 2019 Jun;47(7):1654-1661. doi: 10.1177/0363546519837954. Epub 2019 Apr 30. |
| D017606 |
| Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |