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临床试验/NCT06122727
NCT06122727招募中不适用

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

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Angle Hip Knee Ankle

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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
  • 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

研究组 & 干预措施

CUSTOM

Experimental

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.

干预措施: total knee arthroplasty (Procedure)

TRADITIONAL

Active Comparator

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).

干预措施: total knee arthroplasty (Procedure)

结局指标

主要结局

Angle Hip Knee Ankle

时间窗: 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.

Angle Hip Knee Ankle

时间窗: 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.

次要结局

  • Visual analogic scale(after 24 months)
  • New Knee Society Score(after 24 months)
  • Forgotten Joint Score(after 24 months)
  • Knee injury & Osteoarthritis Outcome Score(after 24 months)
  • Visual analogic scale(at baseline (day 0))
  • Visual analogic scale(after 3 months)
  • Visual analogic scale(after 6 months)
  • Visual analogic scale(after 12 months)
  • New Knee Society Score(at baseline (Day 0))
  • New Knee Society Score(after 3 months)
  • New Knee Society Score(after 6 months)
  • New Knee Society Score(after 12 months)
  • Knee injury & Osteoarthritis Outcome Score(at baseline (Day 0))
  • Knee injury & Osteoarthritis Outcome Score(after 3 months)
  • Knee injury & Osteoarthritis Outcome Score(after 6 months)
  • Knee injury & Osteoarthritis Outcome Score(after 12 months)
  • Forgotten Joint Score(at baseline (day 0))
  • Forgotten Joint Score(after 3 months)
  • Forgotten Joint Score(after 6 months)
  • Forgotten Joint Score(after 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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