Comparing custom and standard knee replacements
Comparison of Customized and Standard Total Knee Replacements: a Pilot Study
This study is testing if custom 3D-printed knee implants can help people with knee osteoarthritis have better surgery results and feel more satisfied compared to standard knee replacements.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06122727 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of custom 3D-printed knee implants compared to standard total knee arthroplasty (TKA) in patients with knee osteoarthritis. The approach utilizes patient-specific instrumentation to ensure precise bone cuts and a better fit of the prosthesis, potentially enhancing stability and durability. Participants will undergo a primary cemented total knee replacement, with the aim of assessing outcomes related to the custom implants. The study seeks to determine if personalized implants can improve surgical results and patient satisfaction.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 40 to 70 who are scheduled for primary cemented total knee replacement.
Not a fit: Patients with significant knee deformities, neurological disorders, or a history of certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved outcomes and satisfaction for patients undergoing knee replacement surgery.
How similar studies have performed: Previous studies have shown promise in the use of custom implants for knee replacements, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female subjects older than 40 years and younger than 70 years (≥ 40 age ≤ 70 years) candidates for primary cemented total knee replacement. * Consenting patients and able to complete scheduled study procedures and follow-up evaluations. * Patients who have signed the "informed consent" approved by the Ethics Committee. Exclusion Criteria: * Social conditions (homeless patients, with restrictions on personal freedom) * ASA 3 * Deep venous insufficiency Lower limbs * History of Erisipelas lower limbs * Neurological or psychocognitive disorders * Neurological diseases * Post-traumatic arthritis * Axial deformities of the knee \>10° * Personal or family history of DVT or EP * Prosthetic and/or arthrodesis surgeries at another joint of the lower extremities lower limb except that candidate for knee prosthesis * Pregnant women * Patients with rheumatic diseases
Where this trial is running
Bologna
- IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: giulio maria marcheggiani muccioli, PHD
- Email: giuliomaria.marcheggianimuccioli@ior.it
- Phone: 0516366
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.