Comparison of Custom and Standard Total Knee Replacements

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: total knee arthroplasty

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: giulio maria marcheggiani muccioli, PHD; Phone Number: 122 0516366; Email: giuliomaria.marcheggianimuccioli@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • IRCCS Istituto Ortopedico Rizzoli
    • Contact: Giulio Maria Marcheggiani Muccioli, MD, PhD; Phone Number: +39 051 6366509; Email: marcheggianimuccioli@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CUSTOM; 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; 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.
Active Comparator: TRADITIONAL; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Arthroplasty, Replacement, Knee
• Other Study ID Numbers: 3POD-TKA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No