Comparison of Custom and Standard Total Knee Replacements

Official title

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

Overview

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.

Interventions

• Procedure total knee arthroplasty
  In detail, in the STANDARD group, 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 guide intramedullary of femur and extramedullary of tibia); in the PERSONALIZED group, patients will undergo a primary TKA by implanting a prosthetic model (YourKnee, Rejoint) with design based specifically on each patient's actual knee morphology and using PSI surgical technique and

Primary outcome measures

• Angle Hip Knee Ankle [Time frame: at baseline (day 0)]
• Angle Hip Knee Ankle [Time frame: 12 months]

Secondary outcome measures (12)

• Visual analogic scale [Time frame: at baseline (day 0)]
• Visual analogic scale [Time frame: after 3 months]
• Visual analogic scale [Time frame: after 6 months]
• Visual analogic scale [Time frame: after 12 months]
• Visual analogic scale [Time frame: after 24 months]
• New Knee Society Score [Time frame: at baseline (Day 0)]
• New Knee Society Score [Time frame: after 3 months]
• New Knee Society Score [Time frame: after 6 months]
• New Knee Society Score [Time frame: after 12 months]
• New Knee Society Score [Time frame: after 24 months]
• Knee injury & Osteoarthritis Outcome Score [Time frame: at baseline (Day 0)]
• Knee injury & Osteoarthritis Outcome Score [Time frame: after 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• IRCCS Istituto Ortopedico Rizzoli — Bologna

Publications

• Lubbeke A, Silman AJ, Barea C, Prieto-Alhambra D, Carr AJ. Mapping existing hip and knee replacement registries in Europe. Health Policy. 2018 May;122(5):548-557. doi: 10.1016/j.healthpol.2018.03.010. Epub 2018 Mar 17. PMID 29598886
• Qiu B, Liu F, Tang B, Deng B, Liu F, Zhu W, Zhen D, Xue M, Zhang M. Clinical Study of 3D Imaging and 3D Printing Technique for Patient-Specific Instrumentation in Total Knee Arthroplasty. J Knee Surg. 2017 Oct;30(8):822-828. doi: 10.1055/s-0036-1597980. Epub 2017 Jan 25. PMID 28122388
• Brinkmann EJ, Fitz W. Custom total knee: understanding the indication and process. Arch Orthop Trauma Surg. 2021 Dec;141(12):2205-2216. doi: 10.1007/s00402-021-04172-9. Epub 2021 Oct 15. PMID 34652517
• Scuderi GR, Bourne RB, Noble PC, Benjamin JB, Lonner JH, Scott WN. The new Knee Society Knee Scoring System. Clin Orthop Relat Res. 2012 Jan;470(1):3-19. doi: 10.1007/s11999-011-2135-0. No abstract available. PMID 22045067

Identifiers

NCT: NCT06122727 · 3POD-TKA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗