Evaluation of 3D printed collars in hip and knee prostheses
Radiological Evaluation of 3D Printed Porous Collars in Resection Prostheses Hip and Knee: Pilot Study.
This study is testing whether 3D printed collars used in hip and knee replacements can help the implants stay stable and prevent bone loss after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06180525 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to assess the osseointegration of 3D printed porous collars used in hip and knee resection prostheses. It involves a multicenter approach, evaluating both retrospective and prospective patient data to determine the effectiveness of these collars in preventing diaphyseal osteolysis and improving implant stability. Patients undergoing surgery with these collars will be monitored for at least one year post-operation to gather clinical and radiological data.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years undergoing hip and knee resection surgeries with 3D printed porous collars.
Not a fit: Patients who are lost to follow-up or lack the necessary clinical documentation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved fixation and longevity of hip and knee prostheses, enhancing patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies evaluating 3D printed implants have shown promising results in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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).
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Nicola Salducca
- Email: nicola.salducca@ifo.it
- Phone: 06-5266.6894
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.