- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01466010
Treatment Outcome After Surgical Treatment of Osteoid Osteoma
Treatment Outcome After Surgical Treatment of Osteoid Osteoma, a Retrospective Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Vlaams Brabant
-
Leuven, Vlaams Brabant, Belgium, 3000
- UZ Leuven Dept of Radiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient with osteoid osteoma at any location.
Exclusion Criteria:
- none.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
osteoid osteoma
patients with osteoid osteoma at any location
|
surgery for osteoid osteoma: this may include curettage or en-bloc resection of the lesion
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S53583
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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