PRP vs Corticosteroid in Baker's Cyst

Baker's Cyst Clinical Trial

Official title:

Clinical Outcomes of Platelet Rich Plasma Injection Versus Corticosteroid Injection for Baker's Cyst

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02249377
• Other study ID #: 14-00457
• Status: Terminated
• Phase: Phase 3
• Start date: February 2014
• Est. completion date: April 1, 2017

Study information

• Verified date: March 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The treatment of Baker's Cysts are based on its presentation, asymptomatic cysts are currently managed conservatively, symptomatic cysts are treated with joint aspiration and Corticosteroid injection, which have shown according to literature a decrease of the cyst size in approximately two-thirds of patients within 2-7 days but only complete disappearance in approximately 7 %. Ultrasound guided cyst aspiration and Corticosteroid injection are also used with reduction of cyst's size with recurrence in 6 months of 19%. Surgical options to remove the cyst include, Open Resection with a recurrence of 50%, 25% of patients have motion limitation recurrence, 37% have wound healing problems or tense swelling of the calf and 75% of patients have joint pain lasting more than 2 days. Arthroscopic resection, with no recurrence in ultrasound performed 6 and 12 months after procedure, pain lasting more than 3 days in 28% of patients, mild hematoma in 7% of patients and 7% where converted into an open procedure

There is no study using ultrasound guided aspiration with platelet-rich-plasma injection (PRP). The rationale for the use of PRP is the belief that the additional platelets will exponentially increase the concentration and release of multiple growth and differentiation factors at the injury site to augment the natural healing process9. PRP does not have any described negative side effect due to the fact that is being prepared from subject's own blood, with no risk of allergy or cross infection, relatively easy for a practiced clinician, and reproducible.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients younger than 18 years old

• Local or Systemic active infection

• Active cancer treatment

• Immunodeficiency

• Diabetes

• Hypersensitivity or allergy to Corticosteroid or Lidocaine

Related Conditions & MeSH terms

• Baker's Cyst
• Cysts

Intervention

Other:
• Platelets-Rich-Plasma
Platelet-Rich Plasma

Drug:
• Corticosteroid
Corticosteroid

Locations

Country	Name	City	State
United States	NYU Hospital for Joint Diseases - Center for Musculoskeletal Care	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

References & Publications (11)

Acebes JC, Sánchez-Pernaute O, Díaz-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. — View Citation

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

Handy JR. Popliteal cysts in adults: a review. Semin Arthritis Rheum. 2001 Oct;31(2):108-18. Review. — View Citation

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

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. — View Citation

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. — View Citation

Köroglu M, Callioglu M, Eris HN, Kayan M, Cetin M, Yener M, Gürses C, Erol B, Türkbey 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. — View Citation

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

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

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. Review. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recurrence of Baker's Cysts Treated on Each Group	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	Complications	All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.	6 Months
Secondary	Side Effects	All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.	6 Months