Plasma Injections Plus Exercise for Patellar Tendinopathy

NCT02116946 | Terminated Phase 2 DMC

• 1 other identifier: H13-00254
• Study Type: interventional
• Target: 64
• Locations: 4 countries
• Sites: 5

Brief 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. 1.Leukocyte-rich PRP injection + exercise
2. 2.Leukocyte-poor PRP injection + exercise
3. 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.

Conditions

Patellar Tendinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in function over time measured by VISA Score

  2 years

• Comparison of treatment success measured by Likert Global Improvement Scale

  2 years

• Change in activity levels over time measured by Tegner Activity Score

  2 years

• Change in activity-related pain over time measured by Pain Numeric Rating Scale

  2 years

Study Arms (3)

Leukocyte-rich Platelet Rish Plasma + exercise

EXPERIMENTAL

Leukocyte-rich PRP injection and a 12 week exercise program.

Biological: Platelet Rich Plasma (PRP)

Leukocyte-poor Platelet Rich Plasma + exercise

EXPERIMENTAL

Leukocyte-poor PRP injection and a 12 week exercise program.

Biological: Platelet Rich Plasma (PRP)

Saline + exercise

PLACEBO COMPARATOR

Saline injection and a 12 week exercise program.

Other: Saline + exercise

Interventions

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.

Also known as: The device Angel cPRP System will be used to make (Leukocyte-rich or -poor) PRP injections

Leukocyte-poor Platelet Rich Plasma + exercise; Leukocyte-rich Platelet Rish Plasma + exercise

Saline + exercise OTHER

Peritendinous saline injection plus 12 week exercise program.

Saline + exercise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• American Orthopaedic Society for Sports Medicine: collaborator
• University of Washington: collaborator
• Rizzoli Orthopaedic Institute: collaborator
• Norwegian Olympic Sports Center: collaborator
• University of Oslo: collaborator
• Steadman Clinic: collaborator

Study Sites (5)

The Steadman Clinic

Vail, Colorado, 81657, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Britich Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

Rizzoli Orthopaedic Institute

Bologna, Italy

Location

Oslo Sports Trauma Research Center

Oslo, Norway

Location

Related Publications (22)

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  BACKGROUND

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• 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.

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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.

  PMID: 31038979 DERIVED

MeSH Terms

Interventions

Poverty; Sodium Chloride; Exercise

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alexander Scott, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 17, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

NO (1); IT (1); US (2); CA (1)