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NCT Number: NCT06122727

Comparison of Custom and Standard Total Knee Replacements

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Giulio Maria Marcheggiani Muccioli, MD, PhD

CONTACT

[email protected]

+39 051 6366509

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total knee arthroplasty

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.

Primary outcomes

  1. Angle Hip Knee Ankle

    Time frame: at baseline (day 0)

    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.

  2. Angle Hip Knee Ankle

    Time frame: 12 months

    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.

Secondary outcomes

  1. Visual analogic scale

    Time frame: at baseline (day 0)

    The VAS scale is an objective method of pain measurement

  2. Visual analogic scale

    Time frame: after 3 months

    The VAS scale is an objective method of pain measurement

  3. Visual analogic scale

    Time frame: after 6 months

    The VAS scale is an objective method of pain measurement

  4. Visual analogic scale

    Time frame: after 12 months

    The VAS scale is an objective method of pain measurement

  5. Visual analogic scale

    Time frame: after 24 months

    The VAS scale is an objective method of pain measurement

  6. New Knee Society Score

    Time frame: at baseline (Day 0)

    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.

  7. New Knee Society Score

    Time frame: after 3 months

    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.

  8. New Knee Society Score

    Time frame: after 6 months

    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.

  9. New Knee Society Score

    Time frame: after 12 months

    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.

  10. New Knee Society Score

    Time frame: after 24 months

    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.

  11. Knee injury & Osteoarthritis Outcome Score

    Time frame: at baseline (Day 0)

    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

  12. Knee injury & Osteoarthritis Outcome Score

    Time frame: after 3 months

    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

  13. Knee injury & Osteoarthritis Outcome Score

    Time frame: after 6 months

    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

  14. Knee injury & Osteoarthritis Outcome Score

    Time frame: after 12 months

    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

  15. Knee injury & Osteoarthritis Outcome Score

    Time frame: after 24 months

    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

  16. Forgotten Joint Score

    Time frame: at baseline (day 0)

    a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment

  17. Forgotten Joint Score

    Time frame: after 3 months

    a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment

  18. Forgotten Joint Score

    Time frame: after 6 months

    a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment

  19. Forgotten Joint Score

    Time frame: after 12 months

    a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment

  20. Forgotten Joint Score

    Time frame: after 24 months

    a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment

Study contacts

Contact information is provided by the study sponsor or research team.

giulio maria marcheggiani muccioli, PHD

CONTACT

[email protected]

0516366 ext. 122

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 8, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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