Comparing custom and standard knee replacements

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• IRCCS Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Study coordinator: giulio maria marcheggiani muccioli, PHD
• Email: giuliomaria.marcheggianimuccioli@ior.it
• Phone: 0516366

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.