A Post-market, Multi-center, Retrospective Study to Identify Clinical Outcomes and Complications Data From Patients Implanted With the Medacta Versafit Cup DM Prosthesis Who Are at Least Two Years Post Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 316
- 试验地点
- 3
- 主要终点
- Limb length
研究概览
简要总结
This is a post-market, retrospective with one prospective visit, multi- center study, designed to assess the clinical outcomes, surgical details including Anterior or Posterior surgical approach, and collect all complication data of Medacta Versafit Cup DM used for primary or revision total hip arthroplasty at minimum two year post- operatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects age 18 years and above at the time of consent
- •Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol. Written informed consent must be obtained prior to any study procedure. 3 Patients must be willing to comply with the prospective visit schedule.
- •Patient underwent a primary or revision total hip replacement for any etiology (osteoarthritis, avascular necrosis, inflammatory arthritis, post- traumatic arthritis, hip fracture, failed prior procedures, etc.).
- •Patients must have received a Medacta Versafit Cup DM component
- •Patient must have adequate pre-operative and post-operative radiographs
- •Patients must be at minimum 2 year (24 months) post-treatment
- •The operation was performed by the investigator.
排除标准
- •History of alcoholism
- •Currently on chemotherapy or radiation therapy
- •Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than hip pain
- •History of a metabolic disorder such as Gout affecting the skeletal system other than osteoarthritis or osteoporosis
- •History of chronic pain issues for reasons other than hip pain
- •Women that are pregnant
- •Patients who underwent Total Hip Arthroplasty (THA) using standard polyethylene
结局指标
主要结局
Limb length
时间窗: Minimum 2 years post surgery
Determined by radiographic analysis by measuring in millimeters
Implant position fixation and wear
时间窗: Minimum 2 years post surgery
Determine by radiographic analysis by measuring Radio Lucent lines in millimeters
Dislocation rate of Medacta Versafit Cup DM
时间窗: Minimum 2 years post surgery
Determine radiographic analysis of component position in millimeters
Patient Satisfaction and outcome score
时间窗: Minimum 2 years post surgery
Determined by the Hip Disability and Osteoarthritis Outcome Score (HOOS) likert scale score
次要结局
- Patient questionnaire Harris Hip Score (HHS)(Minimum 2 years post surgery)
- Surgical Approach(Minimum 2 years post surgery)
- Gait analysis(Minimum 2 years post surgery)
- Implant survivorship(Minimum 2 years post surgery)
- Implant demographics(Minimum 2 years post surgery)
- Complications(Minimum 2 years post surgery)
- Patient questionnaire Forgotten Joint Score (FJS)(Minimum 2 years post surgery)
- Patient questionnaire Likert Scale Score(Minimum 2 years post surgery)
- Range of Motion(Minimum 2 years post surgery)