Treatment Outcome After Surgical Treatment of Osteoid Osteoma

Osteoid Osteoma Clinical Trial

Official title:

Treatment Outcome After Surgical Treatment of Osteoid Osteoma, a Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466010
• Other study ID #: S53583
• Status: Completed
• Phase: N/A
• First received: November 2, 2011
• Last updated: November 4, 2011
• Start date: January 1998
• Est. completion date: January 2010

Study information

• Verified date: September 2011
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Purpose of the study:

To retrospectively determine the clinical results in an unselected group of consecutive patients with osteoid osteoma treated by surgery.

Materials and Methods:

In 150 consecutive patients with clinical and/or radiological evidence for osteoid osteoma at any location, the clinical symptoms and imaging findings (radiographs and computed tomography (CT)) were assessed before and after surgery. There were no exclusion criteria for this study. A good response was defined as disappearance of symptoms that were manifested at presentation and were attributed to osteoid osteoma. Clinical assessment after the procedure was performed prior to discharge; within 2 weeks after the procedure; and at 3, 6, and 12 months follow-up. After 24 months, a postal questionnaire was used for assessment. Radiographic evaluation (radiographs and thin-slice CT) was performed routinely pre-operatively and one year after surgery.

In case of persisting or recurring symptoms the follow-up protocol was again performed according to the initial protocol.

All patients gave their informed consent both for the surgical intervention as for the use of their patient data in this retrospective study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 70 Years

Eligibility

Inclusion Criteria:

• patient with osteoid osteoma at any location.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Osteoid Osteoma
• Osteoma, Osteoid

Intervention

Procedure:
• surgical removal of osteoid osteoma
surgery for osteoid osteoma: this may include curettage or en-bloc resection of the lesion

Locations

Country	Name	City	State
Belgium	UZ Leuven Dept of Radiology	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium,