A Prospective, Multicenter, Single-arm, Interventional OUS Study to Demonstrate the Safety andEffectiveness of the mBos TKA System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- To demonstrate the safety of the mBos TKA System
研究概览
简要总结
The mBos TKA system is a stereotactic planning and implementation device intended to assist surgeons with primary total knee arthroplasty (TKA). It is an alternative to manual TKA template planning and bone preparation for TKA surgeries. This system aids surgeons with virtual implant placement, determining the relative position and orientation of anatomical structures and bone preparation. The mBos TKA System has been extensively evaluated in simulated clinical use conditions with all intended users (surgeons, sterile hospital staff, robot operators etc.). In this proposed clinical study, the Sponsor and Principal Investigators wish to confirm the clinical safety and effectiveness of the mBos TKA System in a representative patient population that would also qualify for traditional TKA surgery. The primary objective of this study is to demonstrate that the mBos System is safe for use as an alternative to manual planning and sawing/cutting techniques, specifically in relation TKA soft tissue complications. This clinical investigation will be conducted as a prospective, non-randomized, multicenter study. This study design has been previously adopted in comparable clinical trials performed to achieve US market approval for similar devices for TKA applications namely “Robotic Arm Assisted Total Knee Arthroplasty”, (NCT02058069, ClinicalTrials.gov, 2016; Sponsor: MAKO, Stryker, USA); “TSolution One® Total Knee Arthroplasty”, (NCT03017261, Clinicaltrials.gov, 2020; Sponsor: Think Surgical, USA); and Stulberg et. al34. Investigators will recruit patients from their practice who require unilateral total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 21.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who are at least 21 years of age, verified by a government-issued identification card/document.
- •Subjects who are skeletally mature, as evidenced radiographically by closed epiphyses.
- •Subjects identified needing unilateral TKA as the primary surgical management of osteoarthritis, and post-traumatic arthritis, defined radiographically by a Kellgren-Lawrence Grade of 3 or higher.
- •Subjects who are, in the opinion of the Investigators and approved study staff, able to understand and comply with this Investigation and its procedures, including being physically present for the required postoperative follow-up procedures.
- •Female subjects of childbearing potential must test negative for pregnancy at the time of screening.
- •6.All screened subjects, capable of fathering or bearing children, must agree to use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study and for 6 months after surgery 7.Menopausal females must have experienced their last period more than 12 months prior to screening to be classified as not of childbearing potential.
- •Subjects who are able to give voluntary, written informed consent to participate in the study and from whom consent has been obtained.
排除标准
- •Candidates will be excluded if they meet any of the following criteria:
- •Subjects who have undergone previous open knee surgery in the operative knee without the mBos robotic system.
- •Subjects whose anatomy is inappropriate for the available range of primary TKA implant
- •Subjects who have a coronal deformity greater than 15° or a sagittal recurvatum greater than 10°, assessed radiographically sizes.
- •Subjects who need a bilateral TKA, where the second TKA is needed within 120 days from the first TKA
- •Subjects who have an active systemic infection or an active local infection in or near the operative knee joint or have a previous history of joint infection.
- •Subjects who have a pathological skeletal condition or skeletal immaturity which would significantly compromise the ability of the bone to withstand the stress required for preparation of the bones and proper implantation of the prostheses.
- •Subjects who have known femoral or tibial bone stock of poor quality or inadequate to provide stability for femoral or tibial fixation.
- •Subjects who have any type of metallic implant in the operative leg.
- •Subjects who have a known or suspected sensitivity to the metals or alloys or any other materials in the investigational device or implant components (i.e. cobalt, chromium, titanium, stainless steel, titanium nitride, aluminum, ultra-high molecular weight polyethylene, PVC plastic).
- •Subjects who have a systemic illness or a neuromuscular, neurosensory, or musculoskeletal deficiency that would render the patient unable to perform appropriate postoperative rehabilitation or create an unacceptable risk of prosthesis instability or fixation failure.
- •Subjects who have significant comorbidities or conditions associated with high risk for surgical or anesthetic survival.
- •Subject has any ongoing or history of underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious, or gastrointestinal condition, which in the opinion of the investigator places the subject at unacceptable risk
- •Subjects with uncontrolled diabetes
- •Subjects who have a previous history of knee joint infection.
- •Subjects who are pregnant or intend to become pregnant during the study.
- •Subjects who have previously experienced a stroke.
- •Subjects participating concurrently in another clinical trial or have participated in a clinical trial within the last 90 days (about 3 months), or intend to during the course of the study.
- •Subjects who have a medical or psychiatric condition which, in the opinion of the investigator, poses a risk of the patient being unable to complete the study or presents risks associated with study participation.
- •Subjects who are known to be drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
结局指标
主要结局
To demonstrate the safety of the mBos TKA System
时间窗: Composite safety endpoint that includes four soft-tissue | complications identified in a literature search and reported below: | 1) Neural Deficit (0.53%, Park et al.1 | ) | 2) Vascular Injury (0.17% Butt et al.,2 | ) | 3) Medial Collateral Ligament Injury (2.2%, Lee et al. 3 | ) | 4) Extensor Mechanism Disruption (2.5%, Boyd et al.4 | ) | The percentage of knees experiencing the composite safety event | in this clinical trial will be compared to the sum 5.4% reported in | literature.
次要结局
- To demonstrate the effectiveness of the mBos TKA System(Postoperative coronal and axial knee implant component and limb Comparison of the 42 days (± 14 days) or at 6 weeks (± 2 weeks) postoperative axial component alignment to the planned alignment.)