Treatment Outcome After Surgical Treatment of Osteoid Osteoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01466010
First received: November 2, 2011
Last updated: November 4, 2011
Last verified: September 2011
  Purpose

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 Intervention
Osteoid Osteoma
Procedure: surgical removal of osteoid osteoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Outcome After Surgical Treatment of Osteoid Osteoma, a Retrospective Study

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Enrollment: 150
Study Start Date: January 1998
Study Completion Date: January 2010
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient with osteoid osteoma at any location.

Criteria

Inclusion Criteria:

  • patient with osteoid osteoma at any location.

Exclusion Criteria:

  • none.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466010

Locations
Belgium
UZ Leuven Dept of Radiology
Leuven, Vlaams Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01466010     History of Changes
Other Study ID Numbers: S53583
Study First Received: November 2, 2011
Last Updated: November 4, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
osteoma, osteoid
surgical procedures, operative
bone neoplasms

Additional relevant MeSH terms:
Osteoma
Osteoma, Osteoid
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 20, 2014