Osteoid OsteomaNCT01466010
Treatment Outcome After Surgical Treatment of Osteoid Osteoma
An observational study of Osteoid Osteoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Osteoid Osteoma
- What is being tested?
- surgical removal of osteoid osteoma
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 1998to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with osteoid osteoma at any location.
Who may be able to join
- patient with osteoid osteoma at any location.
Who cannot join
- none.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Osteoid Osteoma
- Being tested
- surgical removal of osteoid osteoma
- Keywords
- osteoma, osteoid, surgical procedures, operative, bone neoplasms
- Medical subject headings
- Osteoma, Osteoid, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical removal of osteoid osteomaProcedure or surgery
surgery for osteoid osteoma: this may include curettage or en-bloc resection of the lesion
| Study group | Role | What they receive |
|---|---|---|
| osteoid osteoma | patients with osteoid osteoma at any location Receives: Procedure: surgical removal of osteoid osteoma |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startJan 1998
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoid OsteomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466010
- Sponsor's protocol ID
- S53583
- Status last verified
- Sep 2011
- First submitted
- 2 Nov 2011
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcome After Surgical Treatment of Osteoid Osteoma, a Retrospective Study
- ClinicalTrials.gov ID
- NCT01466010
- Acronym / sponsor ID
- S53583
- Conditions
- Osteoid Osteoma
- Keywords
- osteoma, osteoid, surgical procedures, operative, bone neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 1998
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteoid osteoma | – | Procedure: surgical removal of osteoid osteomapatients with osteoid osteoma at any location |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with osteoid osteoma at any location.
Key inclusion criteria (1 listed)
- patient with osteoid osteoma at any location.
Key exclusion criteria (1 listed)
- none.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical removal of osteoid osteomasurgery for osteoid osteoma: this may include curettage or en-bloc resection of the lesion | Procedure or surgery | osteoid osteoma |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoid Osteoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2011.