Platelet-Rich Plasma (PRP) Injection for the Treatment of Chronic Patellar Tendinopathy

NCT01843504 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 2018-01772012-0723Protocol Version Date 1/29/16
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to find an effective treatment for chronic patellar tendinopathy (PT). Investigators will conduct a 32-week randomized controlled clinical trial to determine whether platelet rich plasma (PRP) injections improve disease-specific clinical outcomes with correlation to a new method of ultrasound (US) imaging assessment called Acoustoelastography (AE). Positive findings of PRP compared to control would suggest future larger scale studies to help establish an optimal protocol for the nonsurgical management of PT.

Conditions

Chronic PT; Chronic Patellar Tendinopathy

Keywords

platelet rich plasma; PRP; plasma; plasma injection; patellar tendinopathy; patella tendon; patella; ultrasound; shear wave ultrasound; tendinosis; tendinopathy; tendinitis; jumper's knee

Outcome Measures

Primary Outcomes (3)

• Victorian Institute of Sport Assessment-Patellar (VISAP) Score

  Participants will complete outcome questionnaires at baseline and 32 weeks. The results will evaluate pain- and function-dependent, knee-specific quality of life, as assessed by composite scores on the validated Victorian Institute of Sport Assessment-Patellar (VISAP). The total possible range of scores is 0-100 with higher scores indicating fewer symptoms and higher function.

  baseline and 32 weeks

• International Knee Documentation Committee (IKDC) Score

  Participants will complete outcome questionnaires at baseline and 32 weeks. The results will evaluate pain- and function-dependent, knee-specific quality of life, as assessed by composite scores on the International Knee Documentation Committee (IKDC). The total possible range of scores is 0-100 with higher scores indicating higher function and lower symptoms.

  baseline and 32 weeks

• Knee Injection Questionnaire Score

  Participants will complete outcome questionnaires at weeks 0, 4, 8, 12, 16, and 32 weeks. The results will evaluate pain- and function-dependent, knee-specific quality of life, as assessed by composite scores on the Knee Injection Questionnaire. The total possible range of scores is 0-100 with higher scores indicating improved well being and ability to activities.

  0, 4, 8, 12, 16, and 32 weeks

Secondary Outcomes (4)

• Thickness of Patellar Tendon Compared to Contralateral

  baseline to 32 weeks

• Neovascularity of Patellar Tendon

  baseline to 32 weeks

• Hypoechogenicity of Patellar Tendon

  baseline to 32 weeks

• Stiffness of Patellar Tendon

  baseline to 32 weeks

Other Outcomes (1)

• Knee Injection Survey: PRP Satisfaction Questionnaire

  up to 32 weeks

Study Arms (2)

Platelet Rich Plasma

ACTIVE COMPARATOR

Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous platelet-rich plasma at week 0 (baseline).

Biological: platelet rich plasma

Group 2

PLACEBO COMPARATOR

Subjects in Group 2 (saline control) will receive a single injection of 5 mL 0.9% normal saline at week 0.

Other: saline

Interventions

platelet rich plasma BIOLOGICAL

A blood draw of 15 mL of the subject's own blood will be performed. The study coordinator will then place the sample in the Platelet Separator System (a centrifuge) and spin the blood sample in using a two-stage spinning: the 1st separates red blood cells from platelets, and the 2nd concentrates the platelets. This will be spun by centrifuge to yield 6 mL of concentrated autologous platelet. Under continuous ultrasound evaluation, 1.0-2.0 mL of the prepared PRP will be injected onto the origin of the patella tendon itself will be peppered along a short segment of the tendon into the areas of palpated tenderness and US-documented pathology.

Platelet Rich Plasma

saline OTHER

A blood draw of 15 mL of the subject's own blood will be performed to maintain blinding. Under continuous ultrasound evaluation, 1.0-2.0 mL of the saline solution will be injected onto the origin of the patella tendon itself will be peppered along a short segment of the tendon into the areas of palpated tenderness and US-documented pathology.

Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age18-65
• chronic (\>3months) patellar tendon pain;
• clinical exam findings consistent with PT;
• self-reported failure of supervised physical therapy;
• self-reported failure of at least 2 of the most common treatments (NSAIDs, relative rest, ice, bracing) for patellar tendinopathy.

You may not qualify if:

• inability to comply with follow-up requirements of study,
• history of bleeding disorders, low-platelet counts, other hematologic conditions;
• knee pain due to another possible etiology(e.g., degenerative joint disease);
• current or recent use of anticoagulation or immunosuppressive therapy;
• known allergy to acetaminophen or Lidocaine;
• self-reported pregnancy;
• worker's compensation injury;
• pending litigation;
• concurrent opioid use for pain

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (2)

Wisconsin Institute of Medical Research

Madison, Wisconsin, 53705, United States

Location

UW Sports Medicine Clinic at Research Park

Madison, Wisconsin, 53711, United States

Location

Related Publications (1)

• Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.

  PMID: 15085519 BACKGROUND

MeSH Terms

Conditions

Patella Fracture; Tendinopathy

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: John Wilson, MD, MS
• Organization: UW School of Medicine and Public Health

wilson@ortho.wisc.edu

(608) 628-8200

Study Officials

• John J. Wilson, MD, MS

  UW-Madison School of Medicine & Public Health

  PRINCIPAL INVESTIGATOR

• Stephen J. Almasi, MD

  UW-Madison School of Medicine & Public Health

  PRINCIPAL INVESTIGATOR

• Kenneth S. Lee, MD

  UW-Madison School of Medicine & Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: April 30, 2013
• Study Start: February 25, 2014
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: July 22, 2026
• Results First Posted: July 22, 2026

Record last verified: 2026-06

Locations

US (2)