Comparison of Custom and Standard Total Knee Replacements
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 20 people, planned
- Started
- 1 Mar 2023
- Expected to end
- 30 Apr 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- total knee arthroplasty
- Record updated
- 4 May 2026
Who can take part
- Age
- 40 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Social conditions (homeless patients, with restrictions on personal freedom)
- Deep venous insufficiency Lower limbs
- History of Erisipelas lower limbs
- Neurological or psychocognitive disorders
- Neurological diseases
- Personal or family history of DVT or EP
- Patients with rheumatic diseases
- ASA 3
- Post-traumatic arthritis
- Axial deformities of the knee >10°
- Prosthetic and/or arthrodesis surgeries at another joint of the lower extremities lower limb except that candidate for knee prosthesis
- Pregnant women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 70 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- CUSTOMTreatment being tested
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.
Treatment: total knee arthroplasty
- TRADITIONALExisting treatment, for comparison
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).
Treatment: total knee arthroplasty
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparison of Customized and Standard Total Knee Replacements: a Pilot Study
- Fit questions
- Built from NCT06122727, who can take part
- Record updated
- 4 May 2026