Simple Bone Cysts in Kids

Conditions

• Bone Cyst

Eligibility Criteria

Sex

ALL

Age

2 Years - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Curettage with puncture (C & P) — PROCEDURE
  A curette will be inserted to scrape the contents of the cyst (curettage) and a hole in the cyst wall will be made (puncture) near the bone marrow cavity
• Curette — DEVICE
  A small surgical instrument with a rounded edge designed for scraping
• Vitoss morsels — DEVICE
  A bone substitute intended for use as a filler for voids or gaps in bones

Study Details

Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one is better than another. The purpose of this research trial is to compare the effectiveness of two common treatments that are used by surgeons today.

Key Dates

Start date

Mar 31, 2015

Status verified

Jul 2023

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: C & P
  Curettage with puncture (C \& P) will be performed alone
• Active Comparator: C & P with Vitoss
  A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P)

Primary Outcome Measure

Cyst healing [ Time Frame: 2 years ]

Central Contacts

• Project Manager
  [email protected]

Locations (11)

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