Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented

Официальное название

Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented. Prospective, Randomized, Single-center, Multisite Non-inferiority Study.

Обзор

Total knee replacement surgery (TKA) is a treatment for advanced tibial-femoral osteoarthritis. This intervention is justified in case of significant discomfort and failure of medical treatment. It aims to replace the native internal and external femoro-tibial joints with a joint between a femoral implant and a tibial implant. Implants can be cemented or cementless. The longevity of these implants depends among other things on the quality of the bone fixation of the implants. It is therefore essential that this fixation be evaluated. The advantages of an uncemented TKA are the preservation of bone stock, the absence of wear by cement debris and prolonged fixation thanks to osseointegration. These characteristics are all the more interesting in a young population. Numerous studies have been carried out on the survival of TKA with and without cement. The results found are not unanimous and mainly concern the survival of the implants and the presence of radiological signs of loosening. In addition, no study has evaluated the results of TKA with or without cement implanted using robotic assistance. The precision provided by the robotic system could improve the results of these uncemented implants. Very few studies are interested in the functional results according to the cementation or not of TKA. And most of these studies do not have a high level of methodological evidence. We would like to prospectively evaluate the functional results, survival, as well as the rate of radiological border after TKA with or without cement posed with robotic assistance, in the short and medium term.

Вмешательства

• Устройство Knee prosthesis implementation with additional cement
  During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot with additional cement.
• Устройство Knee prosthesis implementation without additional cement
  During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot without additional cement.

Первичные конечные точки

• Change from baseline in International Knee Society (IKS) function score at 12 Months [Срок оценки: Baseline and 12 months]

Вторичные конечные точки (7)

• Change from baseline in IKS objective score at 12 Months [Срок оценки: Baseline and 12 months]
• Change from baseline in IKS function score at 60 Months [Срок оценки: Baseline and 60 months]
• Change from baseline in IKS objective score at 60 Months [Срок оценки: Baseline and 60 months]
• Forgotten joint score at 12 Months [Срок оценки: 12 months]
• Forgotten joint score at 60 Months [Срок оценки: 60 months]
• Presence of progressive radiological border at 12 Months [Срок оценки: 12 months]
• Unsealing free survival at 60 months [Срок оценки: 60 months]

Критерии участия

Критерии включения

• Diagnosis of internal, external or global femorotibial knee osteoarthritis
• Indication for first-line total knee arthroplasty
• having given informed consent
• Affiliated with a social security scheme
• Patient being able to understand the objectives of the study and willing to comply with postoperative instructions.

Критерии исключения

• Patient with rheumatoid arthritis
• Preoperative flexion less than 90 °
• Prosthesis associated with an osteotomy
• History of surgery on the operated knee, except arthroscopy
• Poor bone quality assessed by the surgeon
• Knee deformation greater than 10 ° preoperatively (HKA)
• Pregnant or breastfeeding Women
• Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a health or social institution for purposes other than research
• Adults subject to a legal protection measure
• Patient already participating to another clinical trial that might jeopardize the current trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• Department of orthopedic surgery, Hopital Nord Croix-Rousse- Hospices Civils de Lyon — Lyon
• Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de — Lyon

Идентификаторы

NCT: NCT04692714 · 69HCL20_0872

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗