Treatment of benign bone lesions with an injectable bone filler material
| ISRCTN | ISRCTN10903007 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10903007 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 1218/2016 |
| Sponsor | Medical University of Vienna |
| Funder | Investigator initiated and funded |
- Submission date
- 14/07/2022
- Registration date
- 21/07/2022
- Last edited
- 21/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Benign bone lesions are areas of bone that are changed or damaged but are not cancerous. The established surgical treatments of benign bone lesions consist of open and minimally invasive surgery. In recent years, injectable and moldable bone graft materials have been developed for filling fluid-filled bone lesions in minimally invasive surgery. This study aims to retrospectively assess minimally invasive and open surgeries using an injectable bone graft material.
Who can participate?
Patients treated with an injectable bone graft material for benign bone lesions with a complete set of data and a postoperative follow-up of at least 1 year
What does the study involve?
The clinical records and x-ray images of patients are assessed.
What are the possible benefits and risks of participating?
Although there are no direct benefits for reviewed patients, future patients and treating surgeons might benefit from the conclusions made from this retrospective data analysis.
Where is the study run from?
Medical University of Vienna (Austria)
When is the study starting and how long is it expected to run for?
February 2016 to March 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Catharina Chiari, catharina.chiari@meduniwien.ac.at
Contact information
Principal investigator
Department of Orthopedics and Trauma Surgery
Medical University of Vienna
Währinger Gürtel 18-20
Vienna
1090
Austria
| Phone | +43 (0)14040040830 |
|---|---|
| catharina.chiari@meduniwien.ac.at |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective single-center data analysis |
| Secondary study design | Case series |
| Study type | Participant information sheet |
| Scientific title | Treatment of benign bone lesions with an injectable biphasic bone substitute |
| Study objectives | Injectable biphasic bone graft substitutes represent a modern alternative for conventional options of bone defect filling, as they further open the possibilities of percutaneous cavity reconstruction. Although recent studies showed good surgical outcomes after treatment with injectable biphasic bone graft substitutes, mid-term follow-ups are still missing. |
| Ethics approval(s) | Approved 27/07/2016, Ethics Committee of the Medical University of Vienna (Borschkegasse 8b/E06, Vienna, Austria; +43 (0)1 40400 21470; ethik-kom@meduniwien.ac.at), ref: 1218/2016 |
| Health condition(s) or problem(s) studied | Benign bone lesions |
| Intervention | After the approval of the local ethics committee, a retrospective data analysis of the in-house software system will identify patients who were treated with Cerament® Bone Void Filler (Bonesupport™, Lund, Sweden) for benign bone lesions. After the application of inclusion criteria, patients will be included in this retrospective analysis. Research questions: 1. What was the treatment failure rate after surgical treatment with a biphasic ceramic bone substitute? 2. How did the cavity morphology change in the postoperative course? 3. What were the treatment-specific complications? |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Local recurrences identified by retrospective analysis of patient charts in the timeframe between surgery and last follow-up at the outpatient clinic |
| Key secondary outcome measure(s) |
1. Postoperative cavity morphology changes assessed using x-rays at 6 weeks, 3 months, 6 months, 12 months, 18 months and at the last follow-up after surgery (MRI will be assessed in cases of suspected recurrence or incomplete cavity consolidation) |
| Completion date | 27/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | All |
| Target sample size at registration | 18 |
| Total final enrolment | 18 |
| Key inclusion criteria | Patients who: 1. Received treatment with a ceramic biphasic bone substitute 2. For benign bone tumors and tumor-like lesions 3. With a complete set of retrospective information, including surgical protocols, X-rays, patient dismission letters and outpatient clinic protocols 4. With a minimum follow-up of 1 year after surgery |
| Key exclusion criteria | 1. Inconclusive data with missing surgical or histological reports |
| Date of first enrolment | 27/07/2016 |
| Date of final enrolment | 18/12/2021 |
Locations
Countries of recruitment
- Austria
Study participating centre
Vienna
1090
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated and analysed during the current study are available upon reasonable request from Ao.Univ.-Prof. Dr Catharina Chiari (catharina.chiari@meduniwien.ac.at). Type of data: retrospective data including demographic parameters, surgery-specific data, data on preoperative and postoperative imaging. The pseudonymized data will become available on reasonable request after study publication for members of the scientific community. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/07/2022: Trial's existence confirmed by the Ethics Committee of the Medical University of Vienna.
