NCT01466010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
12 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2011

Completed
Last Updated

November 7, 2011

Status Verified

September 1, 2011

First QC Date

November 2, 2011

Last Update Submit

November 4, 2011

Conditions

Keywords

osteoma, osteoidsurgical procedures, operativebone neoplasms

Study Arms (1)

osteoid osteoma

patients with osteoid osteoma at any location

Procedure: surgical removal of osteoid osteoma

Interventions

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

osteoid osteoma

Eligibility Criteria

Age2 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with osteoid osteoma at any location.

You may qualify if:

  • patient with osteoid osteoma at any location.

You may not qualify if:

  • none.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven Dept of Radiology

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Osteoma, OsteoidBone Neoplasms

Condition Hierarchy (Ancestors)

OsteomaNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2011

First Posted

November 7, 2011

Study Start

January 1, 1998

Study Completion

January 1, 2010

Last Updated

November 7, 2011

Record last verified: 2011-09

Locations