Plasma Injections Plus Exercise for Patellar Tendinopathy
NCT ID: NCT02116946
Last Updated: 2018-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
64 participants
INTERVENTIONAL
2014-03-31
2018-12-31
Brief Summary
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1. Leukocyte-rich PRP injection + exercise
2. Leukocyte-poor PRP injection + exercise
3. Saline injection + exercise (control) Primary endpoints are (1) the number (rate) and severity of adverse events as reported by both patients and study physicians during the first 12 weeks after initiation of treatment, (2) patient-rated tolerability of treatment; (3) the change in function (VISA score) and treatment success (global improvement scale) over six months of a post-injection exercise protocol.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Leukocyte-rich Platelet Rish Plasma + exercise
Leukocyte-rich PRP injection and a 12 week exercise program.
Platelet Rich Plasma (PRP)
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.
Leukocyte-poor Platelet Rich Plasma + exercise
Leukocyte-poor PRP injection and a 12 week exercise program.
Platelet Rich Plasma (PRP)
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.
Saline + exercise
Saline injection and a 12 week exercise program.
Saline + exercise
Peritendinous saline injection plus 12 week exercise program.
Interventions
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Platelet Rich Plasma (PRP)
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.
Saline + exercise
Peritendinous saline injection plus 12 week exercise program.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documentation of a clinical diagnosis of patellar tendinopathy, grade-IIIB Blazina stage, confirmed on ultrasound
* Previously tried an exercise program of at least six weeks duration
* Fluent in official language of study site
* Written informed consent obtained from subject
* Normal values on screening laboratory panels (CBC, PT, PTT, INR, serum creatine, ALT, ALP, AST, bilirubin, albumin)
Exclusion Criteria
* Major surgery in the past three months
* Surgery on the symptomatic knee
* Bleeding disorder
* Systemic inflammatory disease
* Arthritis or degenerative knee condition
* Recent fluoroquinolone use
* Subjects who have any requirement for the use of systemic steroids or immunosuppressants
* Subjects who are known to be HIV positive
* Uncooperative patient, or patients who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
18 Years
50 Years
ALL
No
Sponsors
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American Orthopaedic Society for Sports Medicine
OTHER
University of Washington
OTHER
Rizzoli Orthopaedic Institute
UNKNOWN
Norwegian Olympic Sports Center
UNKNOWN
University of Oslo
OTHER
Steadman Clinic
UNKNOWN
University of British Columbia
OTHER
Responsible Party
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Alexander Scott
Principal Investigator
Principal Investigators
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Alexander Scott, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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The Steadman Clinic
Vail, Colorado, United States
University of Washington
Seattle, Washington, United States
University of Britich Columbia
Vancouver, British Columbia, Canada
Rizzoli Orthopaedic Institute
Bologna, , Italy
Oslo Sports Trauma Research Center
Oslo, , Norway
Countries
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References
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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.
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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.
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.
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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.
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.
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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.
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.
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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.
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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.
Other Identifiers
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H13-00254
Identifier Type: -
Identifier Source: org_study_id