Comparison of Custom and Standard Total Knee Replacements

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: total knee arthroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CUSTOM<br>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. | Procedure: total knee arthroplasty<br>* 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 instrumentation. In both groups, the approach of the basic prosthetic design base will be of the Cruciate-Retaining (CR) type with congruent polyethylene (PE), with standard and customized for the STANDARD and CUSTOM group, respectively.<br>|
| Active Comparator: TRADITIONAL<br>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). | Procedure: total knee arthroplasty<br>* 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 instrumentation. In both groups, the approach of the basic prosthetic design base will be of the Cruciate-Retaining (CR) type with congruent polyethylene (PE), with standard and customized for the STANDARD and CUSTOM group, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angle Hip Knee Ankle | 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. | at baseline (day 0) | 
| Angle Hip Knee Ankle | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogic scale | The VAS scale is an objective method of pain measurement | at baseline (day 0) | 
| Visual analogic scale | The VAS scale is an objective method of pain measurement | after 3 months | 
| Visual analogic scale | The VAS scale is an objective method of pain measurement | after 6 months | 
| Visual analogic scale | The VAS scale is an objective method of pain measurement | after 12 months | 
| Visual analogic scale | The VAS scale is an objective method of pain measurement | after 24 months | 
| New Knee Society Score | The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). When calculating the score, deductions are taken for assistive devices and flexion contractures, misalignment, or extension lag. | at baseline (Day 0) | 
| New Knee Society Score | The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). When calculating the score, deductions are taken for assistive devices and flexion contractures, misalignment, or extension lag. | after 3 months | 
| New Knee Society Score | The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). When calculating the score, deductions are taken for assistive devices and flexion contractures, misalignment, or extension lag. | after 6 months | 
| New Knee Society Score | The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). When calculating the score, deductions are taken for assistive devices and flexion contractures, misalignment, or extension lag. | after 12 months | 
| New Knee Society Score | The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). When calculating the score, deductions are taken for assistive devices and flexion contractures, misalignment, or extension lag. | after 24 months | 
| Knee injury & Osteoarthritis Outcome Score | The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life | at baseline (Day 0) | 
| Knee injury & Osteoarthritis Outcome Score | The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life | after 3 months | 
| Knee injury & Osteoarthritis Outcome Score | The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life | after 6 months | 
| Knee injury & Osteoarthritis Outcome Score | The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life | after 12 months | 
| Knee injury & Osteoarthritis Outcome Score | The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life | after 24 months | 
| Forgotten Joint Score | a patient-reported outcome measure intended to determine a patient's ability to forget about their affected joint after surgery or treatment | at baseline (day 0) | 
| Forgotten Joint Score | a patient-reported outcome measure intended to determine a patient's ability to forget about their affected joint after surgery or treatment | after 3 months | 
| Forgotten Joint Score | a patient-reported outcome measure intended to determine a patient's ability to forget about their affected joint after surgery or treatment | after 6 months | 
| Forgotten Joint Score | a patient-reported outcome measure intended to determine a patient's ability to forget about their affected joint after surgery or treatment | after 12 months | 
| Forgotten Joint Score | a patient-reported outcome measure intended to determine a patient's ability to forget about their affected joint after surgery or treatment | after 24 months |