Comparison of Custom and Standard Total Knee Replacements

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Procedure: total knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT06122727

3POD-TKA

Details and patient eligibility

About

Total knee arthroplasty (TKA) is the most common surgery in North America and the second most common in Europe. One of the most critical issues for stability and durability of the interventional is the prosthesis-bone geometric fit, where a required a perfect match; the recent availability of custom 3D implants can overcome this problem. In order to further improve a TKA surgery, it is in fact, it is possible today to completely customize the procedure for each individual patient, with cost and time now accessible. This intervention can be performed with the use of instrumentation specific to the patient (so-called resin 'cutting templates' referred to as PSI, "Patient Specific Instrumentation") to make cuts accurate bone cuts in accordance with a specific 3D preoperative plan . Also the design and fabrication in of the components prosthetic components themselves, in metal and polyethylene, is done by means of 3D printing. Based on the unique anatomy of each patient, the precise sagittal orientation and axial rotation of the components of the prosthesis customized for the surgeon, it is possible to plan and perform the surgery quickly and in accordance with the exact specifications of the individual patient. These procedures should also make it possible to greatly reduce the instrumentation and the sizes that need to be available in the operating room, reducing time and costs associated with transportation and storage . The objective of this study is to compare primary TKAs performed with a customized procedure (prostheses customized for each patient based on his or her reconstructed knee morphology by tomographic scans, and implanted via cutting guides customized for the patient) with standard primary TKAs, considering: the objective radiological results, the subjective results of the patients and the costs of both procedures.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

CUSTOM

Experimental group

Description:

patients will undergo primary TKA by implanting a prosthetic model (YourKnee, Rejoint) with a design specifically based on each patient's real knee morphology and using PSI surgical technique and instrumentation.

Treatment:

Procedure: total knee arthroplasty

TRADITIONAL

Active Comparator group

Description:

patients will undergo a primary TKR by implanting a prosthetic model of the same standard design for all using the usual surgical technique and instrumentation (based on the use of the guided intramedullary femur and extramedullary tibia).

Treatment:

Procedure: total knee arthroplasty