Plasma Injections Plus Exercise for Patellar Tendinopathy

Patellar Tendinopathy Clinical Trial

— PHS  

Official title:

Intratendinous Injections of Platelet Rich Plasma With or Without Leukocyte Enrichment for Patellar Tendinopathy: a Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02116946
• Other study ID #: H13-00254
• Status: Terminated
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Male or female = 18 and = 50 years of age at Enrollment Visit

• 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:

• For women of child-bearing potential, positive pregnancy test at enrollment visit

• 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

Related Conditions & MeSH terms

• Patellar Tendinopathy
• Tendinopathy

Intervention

Biological:
• 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.

Other:
• Saline + exercise
Peritendinous saline injection plus 12 week exercise program.

Locations

Country	Name	City	State
Canada	University of Britich Columbia	Vancouver	British Columbia
Italy	Rizzoli Orthopaedic Institute	Bologna
Norway	Oslo Sports Trauma Research Center	Oslo
United States	University of Washington	Seattle	Washington
United States	The Steadman Clinic	Vail	Colorado

Sponsors (7)

Lead Sponsor	Collaborator
University of British Columbia	American Orthopaedic Society for Sports Medicine, Norwegian Olympic Sports Center, Rizzoli Orthopaedic Institute, Steadman Clinic, University of Oslo, University of Washington

Countries where clinical trial is conducted

United States,  Canada,  Italy,  Norway, 

References & Publications (21)

Bahr R, Fossan B, Løken 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. — View Citation

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. Epub 2006 Aug 18. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Ferretti A. Epidemiology of jumper's knee. Sports Med. 1986 Jul-Aug;3(4):289-95. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Larsson ME, Käll 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. Review. — View Citation

Lian O, Engebretsen L, Ovrebø 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. — View Citation

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. Epub 2005 Feb 8. — View Citation

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. — View Citation

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.

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Comparison of treatment success measured by Likert Global Improvement Scale	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
Secondary	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
Secondary	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