Bone TumorCOLLARSNCT06180525
Radiological Evaluation of 3D Printed Porous Collars in Hip and Knee Resection Prostheses: Pilot Study.
An observational study of Bone Tumor, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
This study aims to evaluate the osseointegration of 3D printed porous collars in hip and knee resection prostheses, in order to eliminate one of the causes of diaphyseal osteolysis, which often lead to loosening of the implants, and therefore to guarantee a further improvement in fixation of the implants in terms of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Tumor
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 1 Jun 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: A total of 30 patients will be enrolled consecutively (of which 10 patients consecutively retrospective).
Who may be able to join
- age > 18 years at the time of surgery.
- patients undergoing hip and knee resection prosthesis surgery with the use of collars porous 3D printed.
- date of intervention: starting from the regular entry into use of 3D printed porous collars at the reference center.
- Patients operated on for primary tumor outcomes.
- Patients operated on for infection.
- Patients operated for revisions with severe loss of bone substance.
- Patients capable of giving informed consent and obtaining written informed consent (prospective part/patients in follow-up).
Who cannot join
- Patients lost to follow-up and/or for whom radiographic and clinical documentation is not available corresponding to the post-operative moment and the clinical follow-up visit (6 months and 1 years).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Roberto Biagini, MD, ND, roberto.biagini@ifo.it
About this study
Official title: Radiological Evaluation of 3D Printed Porous Collars in Resection Prostheses Hip and Knee: Pilot Study.
This study aims to evaluate the osseointegration of 3D printed porous collars in hip and knee resection prostheses, in order to eliminate one of the causes of diaphyseal osteolysis, which often lead to loosening of the implants, and therefore to guarantee a further improvement in fixation of the implants in terms of both primary and secondary stability.
Read the detailed description
Non-interventional, retro-prospective, non-pharmacological multicenter pilot study.
The objective of the study is the radiological and clinical evaluation of collar osteointegration porous 3D printed in hip and knee resection prostheses.
Aims to enroll patients undergoing resection prosthesis surgery hip and knee with the use of 3D printed porous collars, performed according to normal practice clinic at the institutions participating in the study.
It is structured in a retrospective part which will evaluate the patients for whom follow-up data is available at the time of the start of the study up to at least 1 year after the operation. And a prospective part (both with regard to patients not yet subjected to intervention, at the start of the study, according to the inclusion criteria, both regarding those in follow-up for whom data are not available according to the time of observation required (1 year)) which will begin once all the necessary authorizations have been obtained administrative requests.
- Conditions
- Bone Tumor
- Keywords
- Radiological evaluation, Clinical evaluation
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective part | Patients for whom follow-up data up to at least 1 year after surgery is available at the start of the study. | |
| Prospective part | Both for patients not yet undergoing treatment intervention, at the start of the study, according to the inclusion criteria, both regarding those in follow-up for whom data are not available according to the time of observation required (1 year), will begin once all necessary authorizations have been obtained administrative requests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological evaluation
Osseointegration will be assessed by x-ray analysis 6 months and 1 year after surgery
Measured: 6 months and 1 year
Secondary outcomes (1)
QoL evaluation
Patient satisfaction/quality of life will be assessed 6 months and 1 year after surgery validated clinical questionnaire (Oxford score).
Bone remodeling will be evaluated by x-ray analysis 6 months and 1 year after surgery. Number of adverse events of any nature during follow-up. Highlight any inter-observer variability in the detection of radiological measurements.
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Dec 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone TumorStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- San Filippo Neri General Hospital, Istituto Ortopedico Rizzoli, A.O.U. Città della Salute e della Scienza
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180525
- Sponsor's protocol ID
- RS1793/22(2702)
- Acronym
- COLLARS
- Status last verified
- Mar 2024
- First submitted
- 12 Dec 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Evaluation of 3D Printed Porous Collars in Resection Prostheses Hip and Knee: Pilot Study.
- ClinicalTrials.gov ID
- NCT06180525
- Acronym / sponsor ID
- COLLARS / RS1793/22(2702)
- Conditions
- Bone Tumor
- Keywords
- Radiological evaluation, Clinical evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- San Filippo Neri General Hospital, Istituto Ortopedico Rizzoli, A.O.U. Città della Salute e della Scienza
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 22 Dec 2023 (actual)
- 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.
This study aims to evaluate the osseointegration of 3D printed porous collars in hip and knee resection prostheses, in order to eliminate one of the causes of diaphyseal osteolysis, which often lead to loosening of the implants, and therefore to guarantee a further improvement in fixation of the implants in terms of both primary and secondary stability.
Detailed description
Non-interventional, retro-prospective, non-pharmacological multicenter pilot study.
The objective of the study is the radiological and clinical evaluation of collar osteointegration porous 3D printed in hip and knee resection prostheses.
Aims to enroll patients undergoing resection prosthesis surgery hip and knee with the use of 3D printed porous collars, performed according to normal practice clinic at the institutions participating in the study.
It is structured in a retrospective part which will evaluate the patients for whom follow-up data is available at the time of the start of the study up to at least 1 year after the operation. And a prospective part (both with regard to patients not yet subjected to intervention, at the start of the study, according to the inclusion criteria, both regarding those in follow-up for whom data are not available according to the time of observation required (1 year)) which will begin once all the necessary authorizations have been obtained administrative requests.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective part | – | –Patients for whom follow-up data up to at least 1 year after surgery is available at the start of the study. |
| Prospective part | – | –Both for patients not yet undergoing treatment intervention, at the start of the study, according to the inclusion criteria, both regarding those in follow-up for whom data are not available according to the time of observation required (1 year), will begin once all necessary authorizations have been obtained administrative requests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 30 patients will be enrolled consecutively (of which 10 patients consecutively retrospective).
Key inclusion criteria (7 listed)
- age > 18 years at the time of surgery.
- patients undergoing hip and knee resection prosthesis surgery with the use of collars porous 3D printed.
- date of intervention: starting from the regular entry into use of 3D printed porous collars at the reference center.
- Patients operated on for primary tumor outcomes.
- Patients operated on for infection.
Key exclusion criteria (1 listed)
- Patients lost to follow-up and/or for whom radiographic and clinical documentation is not available corresponding to the post-operative moment and the clinical follow-up visit (6 months and 1 years).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiological evaluation
Time frame: 6 months and 1 year
Osseointegration will be assessed by x-ray analysis 6 months and 1 year after surgery
1 secondary outcome
QoL evaluation
Time frame: 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
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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.
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 Bone Tumor, run by Regina Elena Cancer Institute at 1 site in Italy.
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 7 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Salducca (06-5266.6894, nicola.salducca@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological evaluation (time frame: 6 months and 1 year). It is what the study was designed to measure, not a finding.
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 22 Mar 2024.