Clinical trial NCT06122727: Comparison of Custom and Standard Total Knee Replacements
Official title: Comparison of Customized and Standard Total Knee Replacements: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Angle Hip Knee Ankle
timeFrame: at baseline (day 0)
measure: Angle Hip Knee Ankle
timeFrame: 12 months
Secondary outcomes:
measure: Visual analogic scale
timeFrame: at baseline (day 0)
measure: Visual analogic scale
timeFrame: after 3 months
measure: Visual analogic scale
timeFrame: after 6 months
measure: Visual analogic scale
timeFrame: after 12 months
measure: Visual analogic scale
timeFrame: after 24 months
measure: New Knee Society Score
timeFrame: at baseline (Day 0)
measure: New Knee Society Score
timeFrame: after 3 months
measure: New Knee Society Score
timeFrame: after 6 months
measure: New Knee Society Score
timeFrame: after 12 months
measure: New Knee Society Score
timeFrame: after 24 months
measure: Knee injury & Osteoarthritis Outcome Score
timeFrame: at baseline (Day 0)
measure: Knee injury & Osteoarthritis Outcome Score
timeFrame: after 3 months
measure: Knee injury & Osteoarthritis Outcome Score
timeFrame: after 6 months
measure: Knee injury & Osteoarthritis Outcome Score
timeFrame: after 12 months
measure: Knee injury & Osteoarthritis Outcome Score
timeFrame: after 24 months
measure: Forgotten Joint Score
timeFrame: at baseline (day 0)
measure: Forgotten Joint Score
timeFrame: after 3 months
measure: Forgotten Joint Score
timeFrame: after 6 months
measure: Forgotten Joint Score
timeFrame: after 12 months
measure: Forgotten Joint Score
timeFrame: after 24 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References:
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.
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. Epub 2017 Jan 25.
citation: 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.
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.