Clinical trial NCT02249377: PRP vs Corticosteroid in Baker's Cyst
Official title: Clinical Outcomes of Platelet Rich Plasma Injection Versus Corticosteroid Injection for Baker's Cyst
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Baker's Cyst
Keywords: Baker's Cyst
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Outcome of Baker's Cysts With the Use of Platelets-Rich-Plasma Versus Corticosteroid
timeFrame: 6 Months
Secondary outcomes:
measure: Recurrence of Baker's Cysts Treated on Each Group
timeFrame: 6 Months
measure: Complications
timeFrame: 6 Months
measure: Side Effects
timeFrame: 6 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Hospital for Joint Diseases - Center for Musculoskeletal Care
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Eric J Strauss, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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