Comparison of Custom and Standard Total Knee Replacements

Launched by ISTITUTO ORTOPEDICO RIZZOLI · Nov 3, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring two types of total knee replacement surgeries for patients with knee osteoarthritis: a customized approach using 3D-printed implants and instruments tailored specifically to each patient's knee, and the standard procedure that uses traditional implants. The goal is to see which method provides better results in terms of how well the knee functions after surgery, how patients feel about their recovery, and the costs involved in each type of surgery.

To participate in this trial, you need to be between 40 and 70 years old and a candidate for a total knee replacement surgery. You should also be able to follow the study procedures and give your consent after understanding the details of the trial. If you decide to join, you can expect to undergo a knee replacement surgery that may use either the customized or standard method, and you'll be monitored throughout your recovery to track your progress and any changes in your knee function. It's important to note that certain health conditions, such as severe neurological disorders or a history of specific leg issues, may prevent you from participating.

Gender

ALL

Eligibility 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