Patellar TendinopathyPhase 2PHSNCT02116946
Plasma Injections Plus Exercise for Patellar Tendinopathy
A Phase 2 study testing Platelet Rich Plasma (PRP) and Saline + exercise in people with Patellar Tendinopathy, run by University of British Columbia at 5 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patellar Tendinopathy
- What is being tested?
- Platelet Rich Plasma (PRP) and Saline + exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Mar 2014to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
University of Washington
Seattle, Washington, 98195
The Steadman Clinic
Vail, Colorado, 81657
Canada1 site
University of Britich Columbia
Vancouver, British Columbia, V6T 1Z4
About this study
Official title: Intratendinous Injections of Platelet Rich Plasma With or Without Leukocyte Enrichment for Patellar Tendinopathy: a Randomized Controlled Trial
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:
- Leukocyte-rich PRP injection + exercise
- Leukocyte-poor PRP injection + exercise
- 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.
- Conditions
- Patellar Tendinopathy
- Being tested
- Platelet Rich Plasma (PRP), Saline + exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma (PRP)Biological
Also called The device Angel cPRP System will be used to make (Leukocyte-rich or -poor) PRP injections
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 + exerciseOther
Peritendinous saline injection plus 12 week exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Leukocyte-rich Platelet Rish Plasma + exercise | Experimental | Leukocyte-rich PRP injection and a 12 week exercise program. Receives: Biological: Platelet Rich Plasma (PRP) |
| Leukocyte-poor Platelet Rich Plasma + exercise | Experimental | Leukocyte-poor PRP injection and a 12 week exercise program. Receives: Biological: Platelet Rich Plasma (PRP) |
| Saline + exercise | Placebo comparator | Saline injection and a 12 week exercise program. Receives: Other: Saline + exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Efficacy
Number and frequency of adverse events will be assessed/reported weekly for the first 12 weeks and at the 6 month visit.
Measured: 2 years
Secondary outcomes (4)
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.
Measured: 2 years
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: 79% participant retention after 1 year
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Patellar TendinopathyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- American Orthopaedic Society for Sports Medicine, University of Washington, Rizzoli Orthopaedic Institute, Norwegian Olympic Sports Center, University of Oslo, Steadman Clinic
- Responsible party
- Principal investigator, Alexander Scott, University of British Columbia
- Investigators
- Alexander Scott, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116946
- Sponsor's protocol ID
- H13-00254
- Acronym
- PHS
- Status last verified
- Dec 2018
- First submitted
- 9 Apr 2014
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15722279Ferretti A. Epidemiology of jumper's knee. Sports Med. 1986 Jul-Aug;3(4):289-95. doi: 10.2165/00007256-198603040-00005.
PubMed 3738327Lian 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.
PubMed 8734892Engebretsen 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.
PubMed 21106774Scott, 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.
PubMed 20154324Larsson 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.
PubMed 22186923Bahr 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.
PubMed 16882889Warden 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.
PubMed 18270224Kongsgaard 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.
PubMed 19793213Rees 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.
PubMed 19188560van 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.
PubMed 21543346Filardo 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.
PubMed 19641918Kon 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.
PubMed 19380129Banfi 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.
PubMed 16920768
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratendinous Injections of Platelet Rich Plasma With or Without Leukocyte Enrichment for Patellar Tendinopathy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02116946
- Acronym / sponsor ID
- PHS / H13-00254
- Conditions
- Patellar Tendinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 79% participant retention after 1 year
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- American Orthopaedic Society for Sports Medicine, University of Washington, Rizzoli Orthopaedic Institute, Norwegian Olympic Sports Center, University of Oslo, Steadman Clinic
- Study start
- Mar 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Leukocyte-rich PRP injection + exercise
- Leukocyte-poor PRP injection + exercise
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leukocyte-rich Platelet Rish Plasma + exercise | Experimental | Biological: Platelet Rich Plasma (PRP)Leukocyte-rich PRP injection and a 12 week exercise program. |
| Leukocyte-poor Platelet Rich Plasma + exercise | Experimental | Biological: Platelet Rich Plasma (PRP)Leukocyte-poor PRP injection and a 12 week exercise program. |
| Saline + exercise | Placebo comparator | Other: Saline + exerciseSaline injection and a 12 week exercise program. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich Plasma (PRP)Also: The device Angel cPRP System will be used to make (Leukocyte-rich or -poor) PRP injectionsInjection 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. | Biological | Leukocyte-poor Platelet Rich Plasma + exercise, Leukocyte-rich Platelet Rish Plasma + exercise |
| Saline + exercisePeritendinous saline injection plus 12 week exercise program. | Other | Saline + exercise |
Primary outcome
Clinical Efficacy
Time frame: 2 years
Number and frequency of adverse events will be assessed/reported weekly for the first 12 weeks and at the 6 month visit.
4 secondary outcomes
Change in function over time measured by VISA Score
Time frame: 2 years
Comparison of treatment success measured by Likert Global Improvement Scale
Time frame: 2 years
Change in activity levels over time measured by Tegner Activity Score
Time frame: 2 years
Change in activity-related pain over time measured by Pain Numeric Rating Scale
Time frame: 2 years
Results and safety
The study was stopped early (reason given: 79% participant retention after 1 year). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Background: PubMed 15722279Lian 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.
- Background: PubMed 3738327Ferretti A. Epidemiology of jumper's knee. Sports Med. 1986 Jul-Aug;3(4):289-95. doi: 10.2165/00007256-198603040-00005.
- Background: PubMed 8734892Lian 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.
- Background: PubMed 21106774Engebretsen 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.
- BackgroundScott, 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.
- Background: PubMed 20154324Kongsgaard 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.
- Background: PubMed 22186923Larsson 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.
- Background: PubMed 16882889Bahr 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.
- Background: PubMed 18270224Warden 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.
- Background: PubMed 19793213Kongsgaard 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.
- Background: PubMed 19188560Rees 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.
- Background: PubMed 21543346van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Scott, PhD principal investigator
University of British Columbia
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet Rich Plasma (PRP) and Saline + exercise in people with Patellar Tendinopathy, run by University of British Columbia at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada, Italy, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 79% participant retention after 1 year). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Efficacy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02116946, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.