A Prospective, Multi-center, Randomized Controlled Study to Evaluate Patient Outcomes Using Hip7 Software as Compared to Conventional Surgical Technique in S+N Total Hip Arthroplasties (THA)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Forgotten Joint Score (FJS)
研究概览
简要总结
The study is designed to demonstrate how Hip7 software can lead to improved patient outcomes compared to conventional procedures with standard instrumentation for total hip arthroplasties (THA) surgery.
详细描述
This study is a prospective, multi-center, randomized, controlled clinical study in total hip arthroplasties (THA) surgery. The subjects meeting the inclusion/exclusion criteria specified in the protocol will receive THA using either Hip7 software or conventional instrumentation.
The clinical follow-up evaluation will be performed preoperatively (Baseline), operatively, 6 weeks, 6 and 12 months after surgery using patient reported outcome measures regarding their general health, hip and physical abilities, quality of life and pain level.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject or legal guardian must provide written informed consent (reference section 7.5).
- •Subjects eighteen (18) years or older and considered skeletally mature.
- •Willing and able to make all required study visits.
- •Able to follow instructions and deemed capable of completing the FJS, OHS, HOOS and EQ-5D-5L questionnaires.
- •Subject requires a THA as a primary indication.
- •Subject is a suitable candidate for implanting specific S+N implant system in the investigator's judgement.
- •Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethics Committee (EC) approved informed consent form.
- •Subject plans to be available through 12 months postoperative follow-up
- •Routine radiographic assessment including CT and X-ray is possible.
排除标准
- •Contraindicated for robotic THA or POLAR3 hip implant.
- •Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
- •Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
- •Any subject that meets the definition of a Vulnerable Subject per International Organization for Standardization (ISO) 14155:2011 Section 3.
- •Subjects who have participated previously in this trial through THA on their other hip.
- •Subjects with a history of poor compliance with medical treatment (i.e have mental illness, drug or alcohol addiction).
- •Subjects who need a THA procedure on the index joint as a revision for a previously failed surgery.
- •Subjects suspected to need bilateral surgery in the next 12 months.
- •Subject has received THA on the opposing hip within the previous 6 months.
- •Subjects not understanding the language used in the Informed Consent Form.
- •Subjects with an active infection or sepsis (treated or untreated).
- •Subjects morbidly obese with a BMI greater than
- •Subjects in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and are better suited for an alternate procedure.
- •Subjects that have condition(s) that may interfere with the THA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).
- •Subjects, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.
- •Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
研究组 & 干预措施
Hip7 Software on Kick/ CORI platforms
Subjects will receive total hip arthroplasty surgery using Hip7 on Kick or CORI platform utilizing R3 Polarstem implants.
干预措施: Hip7 Software on Kick/ CORI platforms (Device)
Conventional procedures with standard, manual instrumentation and digital templating techniques
Subjects will receive total hip arthroplasty surgery using conventional procedures with standard instrumentation and digital templating techniques utilizing R3 Polarstem implants.
干预措施: Conventional surgical procedures (Device)
结局指标
主要结局
Forgotten Joint Score (FJS)
时间窗: 12 months post-surgery
Compare Forgotten Joint Score (FJS) utilizing Hip7 software on Kick \& CORI platforms with POLAR3 system to conventional procedures with standard instrumentation and digital templating techniques at 12 months post-operation. The FJS-12 Questionnaire comprises measures for assessment of joint-specific patient reported outcomes that focuses on subject's awareness of replaced joint in everyday life. Joint awareness defined as any unintended perception of a joint. Subjects rate awareness of their hip arthroplasty in 12 questions with a 5-point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". Scores are summed \& linearly transformed in a 0-100 scale with a high value reflecting subject's ability to forget the replaced hip joint during daily living activities.
次要结局
- Assess Range of Motion of Femur at 6 Weeks(6 weeks post-op)
- Patient Reported Outcomes: Hip Disability and Osteoarthritis Outcome Score (HOOS)(12 months post-surgery)
- Assess Pelvic Tilt at 6 Weeks(6 weeks post-op)
- Change in Frequency of Reduction of Outliers(6 weeks post surgery)
- Patient Reported Outcomes: Oxford Hip Score (OHS)(12 months post-surgery)
- Cup placement accuracy(6 weeks post-op)
- Assess Frequency of Femur Head Dislocation at 6 Weeks(6 weeks post-op)
- Patient Reported Outcomes: EuroQol (European Quality of Life) five-dimensional Five-level (EQ-5D-5L)(12 months post-surgery)