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Comparison of Custom and Standard Total Knee Replacements

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 4, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Dec 30, 2025 to Jun 30, 2026
    • Study completion date: Apr 30, 2026 to Apr 30, 2027
    v6
  2. Notable Primary completion date: Jun 30, 2025 to Dec 30, 2025v5
  3. Minor Primary completion date: Apr 30, 2025 to Jun 30, 2025v4
  4. Minor Primary completion date: Mar 1, 2025 to Apr 30, 2025
    • Study completion date: Mar 1, 2025 to Apr 30, 2026
    v3
  5. Minor Re-verified, no change to tracked fieldsv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06122727
Lead Sponsor Istituto Ortopedico Rizzoli
Conditions
(from sponsor)
Knee Osteoarthritis
Related terms Osteoarthritis, Knee
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov