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Clinical Trials/NCT06122727
NCT06122727
Recruiting
Not Applicable

Comparison of Customized and Standard Total Knee Replacements: a Pilot Study

Istituto Ortopedico Rizzoli1 site in 1 country20 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
20
Locations
1
Primary Endpoint
Angle Hip Knee Ankle
Status
Recruiting
Last Updated
9 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
April 30, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)
  • 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

Outcomes

Primary Outcomes

Angle Hip Knee Ankle

Time Frame: 12 months

Evaluate by how many degrees the angle HKA (angle obtained by joining the center of rotation of the knee with that of the hip and ankle) planned (desired value) differs from that measured postoperatively (obtained value) When implanting a customized primary TKA (PERSONALIZED group) vs. a standard primary TKA (STANDARD group) according to normal surgical practice.

Secondary Outcomes

  • Visual analogic scale(after 24 months)
  • New Knee Society Score(after 24 months)
  • Forgotten Joint Score(after 24 months)
  • Knee injury & Osteoarthritis Outcome Score(after 24 months)

Study Sites (1)

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