PRP vs Corticosteroid in Baker's Cyst

NCT02249377 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 14-00457
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Prospective study with Randomized patients into either Ultrasound-guided Platelets-Rich-Plasma injection and Ultrasound guided Corticosteroid Injection, with 3 months and 6 months follow ups after aspiration at our institution. There will be 25 patients in each group, including any patient with symptomatic baker's cyst.

Conditions

Baker's Cyst

Keywords

Baker's Cyst

Outcome Measures

Primary Outcomes (1)

• Outcome of Baker's Cysts With the Use of Platelets-Rich-Plasma Versus Corticosteroid

  Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.

  6 Months

Secondary Outcomes (3)

• Recurrence of Baker's Cysts Treated on Each Group

  6 Months

• Complications

  6 Months

• Side Effects

  6 Months

Study Arms (2)

Platelets-Rich-Plasma Group

EXPERIMENTAL

Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.

Other: Platelets-Rich-Plasma

Corticosteroid group:

ACTIVE COMPARATOR

Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.

Drug: Corticosteroid

Interventions

Platelets-Rich-Plasma OTHER

Platelet-Rich Plasma

Platelets-Rich-Plasma Group

Corticosteroid DRUG

Corticosteroid

Corticosteroid group:

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years old.
• Patients with baker's cyst who also present with at least one of the following: swelling, local pain or discomfort, limited range of motion or any other symptom directly caused by the baker's cyst.

You may not qualify if:

• Patients younger than 18 years old
• Local or Systemic active infection
• Active cancer treatment
• Immunodeficiency
• Diabetes
• Hypersensitivity or allergy to Corticosteroid or Lidocaine

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Hospital for Joint Diseases - Center for Musculoskeletal Care

New York, New York, 10016, United States

Location

Related Publications (11)

• Handy JR. Popliteal cysts in adults: a review. Semin Arthritis Rheum. 2001 Oct;31(2):108-18. doi: 10.1053/sarh.2001.27659.

  PMID: 11590580 BACKGROUND

• Johnson LL, van Dyk GE, Johnson CA, Bays BM, Gully SM. The popliteal bursa (Baker's cyst): an arthroscopic perspective and the epidemiology. Arthroscopy. 1997 Feb;13(1):66-72. doi: 10.1016/s0749-8063(97)90211-5.

  PMID: 9043606 BACKGROUND

• Koroglu M, Callioglu M, Eris HN, Kayan M, Cetin M, Yener M, Gurses C, Erol B, Turkbey B, Parlak AE, Akhan O. Ultrasound guided percutaneous treatment and follow-up of Baker's cyst in knee osteoarthritis. Eur J Radiol. 2012 Nov;81(11):3466-71. doi: 10.1016/j.ejrad.2012.05.015. Epub 2012 Jun 20.

  PMID: 22726355 BACKGROUND

• Ko S, Ahn J. Popliteal cystoscopic excisional debridement and removal of capsular fold of valvular mechanism of large recurrent popliteal cyst. Arthroscopy. 2004 Jan;20(1):37-44. doi: 10.1016/j.arthro.2003.10.017.

  PMID: 14716277 BACKGROUND

• Acebes JC, Sanchez-Pernaute O, Diaz-Oca A, Herrero-Beaumont G. Ultrasonographic assessment of Baker's cysts after intra-articular corticosteroid injection in knee osteoarthritis. J Clin Ultrasound. 2006 Mar-Apr;34(3):113-7. doi: 10.1002/jcu.20210.

  PMID: 16547992 BACKGROUND

• Omer Mei-Dan and Michael R. Carmont. Novel Applications of Platelet-Rich Plasma Technology in Musculoskeletal Medicine and Surgery. Oper Tech Orthop 22:56-63 © 2012 Elsevier

  BACKGROUND

• Steven P. Arnoczky, Demetris Delos, Scott A. Rodeo. What Is Platelet-Rich Plasma? Oper Tech Sports Med 19:142-148 © 2011 Elsevier

  BACKGROUND

• Mikel Sánchez, Javier Albillos, Francisco Angulo, Juanma Santisteban, Isabel Andia. Platelet-Rich Plasma in Muscle and Tendon Healing. Oper Tech Orthop 22:16-24 © 2012 Elsevier

  BACKGROUND

• Andre F. Steinert, Kellie K. Middleton, Paulo H. Araujo, Freddie H. Fu. Platelet-Rich Plasma in Orthopaedic Surgery and Sports Medicine: Pearls, Pitfalls, and New Trends in Research. Oper Tech Orthop 22:91-103 © 2012 Elsevier

  BACKGROUND

• Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.

  PMID: 14613558 BACKGROUND

• J.F. Kaux. Exuberant inflammatory reaction as a side effect of an infiltration of PRP. Médecine du sport (2) : tendinopathies (actualités) / Annals of Physical and Rehabilitation Medicine 56S (2013) e215-e221

  BACKGROUND

MeSH Terms

Conditions

Popliteal Cyst

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Synovial Cyst; Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Eric Strauss, MD
• Organization: New York Langone Health

Eric.Strauss@nyumc.org

646 501 7223

Study Officials

• Eric J Strauss, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 25, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 18, 2020
• Results First Posted: March 18, 2020

Record last verified: 2020-03

Locations

US (1)