NCT03566875Unknown不适用
Etude Clinique, Monocentrique, Prospective, randomisée et contrôlés de l'Arthoplastie Totale de Genou Avec le système Robotique MAKO™ Par Rapport à l'Arthroplastie Totale de Genou Conventionnelle Par Ancillaire mécanique
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Difference between the actual HKA angle obtained postoperatively and the planned HKA angle preoperatively.
研究概览
简要总结
For the total knee arthrorplasty (TKA), the placement of a prosthesis is delicate and the correct positioning of the implants determines the result of the surgery.
Navigation has improved surgical accuracy but remains inadequate with nearly 20% malposition. In the early 2010s, robot-assisted surgery solutions were born. Amongst its offers, Stryker's MAKO™ system appears to be the most advanced and developed due to its precision and its flexibility of use during surgery.
In this study, the investigators evaluate the placement of the total knee prosthesis with the MAKO™ system compared to the placement of the total knee prosthesis with a conventional mechanical system for TKA
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patient
- •Patient who must have a total prosthetic knee surgery at CHUGA with the useful indications : painful and disabling knee joint disease: traumatic arthritis or avascular necrosis, rheumatoid arthritis or post-traumatic arthritis, post-traumatic loss of the configuration and function of the knee joint, moderate deformities in varus, or valgus or flexion in ligamentous structures can find a function and a fracture of the distal femur and / or proximal tibia that can not be stabilized by standard fracture management techniques.
- •Social security affiliates or beneficiaries of a scheme
排除标准
- •refusal of consent,
- •patient with a contraindication to prosthetic knee surgery:
- •any active or suspected latent infection in or around the knee joint,
- •remote foci of infection that can cause haematogenous spread on the implant site,
- •any mental or neuromuscular disorder that would create an unacceptable risk of instability of the prosthesis,
- •failure of prosthesis fixation or complications in postoperative care,
- •a bone stock compromised by a disease,
- •infection or anterior prosthetic implantation that can not provide adequate support and / or satisfactory fixation to the prosthesis,
- •skeletal immaturity,
- •severe instability of the knee joint secondary to the lack of integrity and function of the collateral ligament,
- •woman of childbearing age,
- •patient during the exclusion period of another study,
- •patient referred in Articles L1121-5 to L1121-8 of the Public Health Code
结局指标
主要结局
Difference between the actual HKA angle obtained postoperatively and the planned HKA angle preoperatively.
时间窗: 26 months
HKA (Hip-Knee-Ankle). Angles in degrees are obtained from preoperative 3D scanner and postoperative 3D scanner on day 7.
次要结局
- To compare the mechanical axis between the conventional surgery group and the MAKO™ assisted surgery group.(26 months)
- To compare the functional results between the conventional surgery group and the MAKO™ assisted surgery group.(26 months)
- To compare, between the conventional surgery group and the MAKO™ assisted surgery group, the angles accuracy of inclination and rotation in the 3 planes of the space (frontal, sagittal and axial) to accomplish the preoperative planning. The accuracy(26 months)
- To evaluate the conversion rate in conventional method for patients in the MAKO™ assisted surgery group.(26 months)
- To compare the blood loss during the procedure between the conventional surgery group and the MAKO™ assisted surgery group.(26 months)
- To compare the operative time between the conventional surgery group and the MAKO™ assisted surgery group.(26 months)
- To compare between the conventional surgery group and the MAKO™ assisted surgery group the time needed to reach the hospital discharge criteria.(26 months)
- To compare intraoperative complication rates between the conventional surgery group and the MAKO™ assisted surgery group.(26 months)
- To compare between the conventional surgery group and the MAKO™-assisted surgery group the operating times for surgical installation, bone preparation and implant placement.(26 months)
- To compare the results of early (<1 months) and late (≥ 1 month) postoperative consultations between the conventional surgery group and the MAKO™-assisted surgery group.(26 months)
研究者
研究点 (2)
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