Comparison of Custom and Standard Total Knee Replacements

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122727
• Other study ID #: 3POD-TKA
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: November 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: giulio maria marcheggiani muccioli, PHD
• Phone: 0516366
• Email: giuliomaria.marcheggianimuccioli[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. E — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Visual analogic scale	The VAS scale is an objective method of pain measurement	at baseline (day 0)
Secondary	Visual analogic scale	The VAS scale is an objective method of pain measurement	after 3 months
Secondary	Visual analogic scale	The VAS scale is an objective method of pain measurement	after 6 months
Secondary	Visual analogic scale	The VAS scale is an objective method of pain measurement	after 12 months
Secondary	Visual analogic scale	The VAS scale is an objective method of pain measurement	after 24 months
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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