A Pilot Single-Arm, Multicenter, Prospective, Post-Market 6 Months Follow-Up Clinical Investigation to Evaluate the Safety and Effectiveness of the Blueprint Mixed Reality HOLOBLUEPRINT™ (HOLOBLUEPRINT™).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- PERFORMANCE MEASUREMENT: Glenoid Implant Placement Accuracy
研究概览
简要总结
A pilot Single-Arm, Multicenter, Prospective, Post-Market 6 months Follow-Up Clinical Investigation to Evaluate the Safety and Effectiveness of the Blueprint Mixed Reality HOLOBLUEPRINT™ (HOLOBLUEPRINT™).
详细描述
The purpose of this clinical investigation is to assess performance by collecting post-market performance and safety data. Outcome data collected from this pilot clinical investigation will provide descriptive data on performance and safety for Post-Market Surveillance (PMS) reporting, Clinical investigation Reports (CIR), and Clinical Evaluation Reports (CER).
This France-based pilot clinical investigation will include 4 investigating sites.
The sponsors are seeking to enroll 50 subjects undergoing surgery using HOLOBLUEPRINT™. The inclusion period is expected to take approximately 3 months, at an estimated rate of 13 subjects/month.
In case of implant size difference or necessary changes between the preoperative planning and the actual device implanted, the patient will be excluded (Screen Failure) and no analysis will be performed.
Each time an enrolled patient is operated using HOLOBLUEPRINT™, the site must enroll this patient consecutively, assuming the patient meets inclusion/non-inclusion criteria and provides their signed informed consent to participate (according to local requirements). This process of consecutive enrollment is one means of preventing patient selection bias and should strengthen the value of data collected in the pilot clinical investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •18 years or older at the time of the informed consent.
- •Informed and willing to sign an informed consent approved by Ethics Committee
- •Willing and able to comply with the requirements of the study protocol
- •Considered a candidate for on label shoulder arthroplasty using BluePrint™ 3D planning software and shoulder system:
- •Humeral side: Tornier Perform Humeral Stem
- •Glenoid side: Tornier Perform Reversed Glenoid
排除标准
- •Inability to comply with the pilot clinical investigation procedures based on the judgment of the assessor (e.g. unable to accurately respond to the pilot clinical investigation questionnaires, and inability to attend the scheduled assessments);
- •The subjects belong to a vulnerable group of subjects, including minors, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (subjects who may not be acting on their initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm);
- •Any medical condition that could impact the pilot clinical investigation outcomes' functional significance, at the investigator's discretion (e.g., neuropathy, allergy);
- •Bio RSA (Bone graft (Autograft))
- •Subject pregnancy;
- •Subjects incompatible with Blueprint®'s intended use and CT Protocol (e.g., metallic device close to the shoulder).
结局指标
主要结局
PERFORMANCE MEASUREMENT: Glenoid Implant Placement Accuracy
时间窗: 15 days after surgery
To describe the performance of HOLOBLUEPRINT™ by measuring the difference between postoperative implant placement compared with preoperative simulated implant placement. This will be performed using CT scans and a validated internally developed semi-automated software to compare the postoperative images with the preoperative planning.
次要结局
- FUNCTIONAL EVALUATION AT 6 MONTHS (Range of motion)(6 months after surgery)
- FUNCTIONAL EVALUATION AT 6 MONTHS (ASES Score)(6 months after surgery)
- DURATION OF THE INTERVENTION(Surgery)
- FUNCTIONAL EVALUATION AT 6 MONTHS (Constant score)(6 months after surgery)
- PAIN EVALUATION AT 6 MONTHS (ASES Score)(6 months after surgery)
- FUNCTIONAL EVALUATION AT 6 MONTHS (SANE score)(6 months after surgery)
- SAFETY EVALUATION(Up to 6 months after surgery)