Comparison of Custom and Standard Total Knee Replacements

NCT ID: NCT06122727

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-04-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

total knee arthroplasty

Intervention Type: PROCEDURE

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.

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).

Group Type: ACTIVE_COMPARATOR

total knee arthroplasty

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

giulio maria marcheggiani muccioli, PHD

Role: CONTACT

giuliomaria.marcheggianimuccioli@ior.it

0516366 ext. 122

Facility Contacts

Giulio Maria Marcheggiani Muccioli, MD, PhD

Role: primary

marcheggianimuccioli@me.com

+39 051 6366509

References

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.

Reference Type: RESULT

PMID: 29598886 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28122388 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34652517 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22045067 (View on PubMed)

Other Identifiers

3POD-TKA

Identifier Type: -

Identifier Source: org_study_id