Treatment Outcome After Surgical Treatment of Osteoid Osteoma

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT01466010

Collaborator

(none)

150

Enrollment

Location

144

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoid Osteoma	Procedure: surgical removal of osteoid osteoma

Study Design

Study Type:

Observational

Actual Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jan 1, 1998

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
osteoid osteoma patients with osteoid osteoma at any location	Procedure: surgical removal of osteoid osteoma surgery for osteoid osteoma: this may include curettage or en-bloc resection of the lesion

Arm

Intervention/Treatment

osteoid osteoma

patients with osteoid osteoma at any location

Procedure: surgical removal of osteoid osteoma

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patient with osteoid osteoma at any location.

Exclusion Criteria:

none.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven Dept of Radiology	Leuven	Vlaams Brabant	Belgium	3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT01466010

Other Study ID Numbers:

S53583

First Posted:

Nov 6, 2011

Last Update Posted:

Nov 6, 2011

Last Verified:

Sep 1, 2011

Keywords provided by Universitaire Ziekenhuizen Leuven

osteoma, osteoid

surgical procedures, operative

bone neoplasms

Additional relevant MeSH terms:

Osteoma

Osteoma, Osteoid

Study Results

No Results Posted as of Nov 6, 2011