Clinical Priority Program (CPP) Clinical Outcome Measurement of Fracture Treatment:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,500
- 试验地点
- 15
- 主要终点
- Go Fit Fast: Radiographic measurements, Patient related outcomes (PROs: PROMIS, HOOS, KOOS,), Loading/Activity pattern analysis
研究概览
简要总结
Prospective data will be collected in approximately 3500 patients (700 per 5 injury groups).
Patients will be followed up according to the standard (routine) for up to 1 year after the treatment.
Data collection will include underlying disease, treatment details, patient reported outcomes (PROs), anticipated or procedure-related adverse events (i.e. complications), and radiological outcomes.
详细描述
More in detail this observational study includes the following sub-projects:
I) Weight -bearing and Gait Observation for Fully Individualized Treatment and Aftercare Following Surgery and Trauma
Objectives:
To analyse the association between automated, sensor-based patient activity and loading data, and clinical (Patient Reported Outcomes [PROs]) and radiographic outcome during fracture healing.
II) Recovery Trajectory using PROMIS®: Defining the Recovery Trajectory using PROMIS® to Optimize Decision-making and Outcomes following Extremity Fractures
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age 18 years and older
- •Diagnosis of one of, isolated injury
- •Hip fracture
- •Tibial shaft fracture (with and without associated fibular fracture)
- •Ankle/pilon fracture
- •Proximal humerus fracture
- •Distal radius fracture
- •English, German, or Spanish speaking
- •Informed consent obtained, i.e.:
- •Ability to understand the content of the patient information/ICF
- •Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
- •Signed and dated EC/IRB approved written informed consent
排除标准
- •More than 21 days from day of injury to day of surgery / day of nonoperative treatment decision
- •Patients with multiple fractures
- •Pathological fractures due to cancer
- •Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
- •Pregnancy or women planning to conceive within the study period
- •Patients who are not able to provide independent written informed consent unless defined and IRB/IEC-approved procedures for consenting such vulnerable patients are in place
- •Prisoners
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- •Patients unable to likely achieve anticipated Follow-up (FU)
结局指标
主要结局
Go Fit Fast: Radiographic measurements, Patient related outcomes (PROs: PROMIS, HOOS, KOOS,), Loading/Activity pattern analysis
时间窗: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
* Radiographic measurements o Healing (Radiographic Union Score in Tibia Fractures \[RUST\]/ Radiographic Union Score in Hip Fractures \[RUSH\]) * Patient related outcomes * Patient Reported Outcome Measurement Information System (PROMIS): Physical Function (PF) short form Custom AO14 Pain Interference * Hip Disability and Osteoarthritis Outcome Score (HOOS-12) (assessing short- and long-term symptoms and function in hip injuries; the lower score indicates higher symptoms) * Knee Injury and Osteoarthritis Outcome Score (KOOS-12) (assessing short- and long-term symptoms and function in knee injuries; the lower score indicates higher symptoms) * Loading/Activity pattern analysis: * Number of steps with weight-bearing \>80% body-weight (weight in kg) * pressure distribution \[N/cm2\] * center of pressure \[mm\] * ground reaction forces \[N\] * temporal and spatial parameters (time spent during gait \[min\], stance time \[s\], swing time \[s\], double support time \[s\], cadence \[r/min\], cycle time \[s\])
Recovery Trajectories PROMIS/Linking PROMIS: PROs: PROMIS, HOOS, KOOS, QuickDASH, FAAM
时间窗: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
PROs that measure physical limitations: * PROMIS PF Short Form Custom AO14 (questions that cover the domain of physical function/mobility from self-care to strenuous activities) * PROMIS Upper Extremity (UE) Short Form Custom AO8 (questions assessing arm and hand specific limitations, e.g. difficulty writing, lifting heavy objects; a higher score indicates a better function) * Disabilities of the Arm, Shoulder, and Hand (QuickDASH) (11 questions assessing outcomes in upper extremity disorders; a higher score indicates a greater disability) * HOOS-12 * KOOS-12 * Foot and Ankle Ability Measure (FAAM) (21 items of activities of daily living subscale) * PROMIS Global Health (10 questions assessing physical health, mental health, and social health; a higher score indicates a better general health)
次要结局
- PROMIS Pain Interference(from the treatment assessment until 12 months after the treatment (surgical or not-surgical))
- PROMIS Ability to Participate in Social Roles and Activities(from the treatment assessment until 12 months after the treatment (surgical or not-surgical))
- Pain Self-Efficacy Questionnaire (PSEQ)-2(from the treatment assessment until 12 months after the treatment (surgical or not-surgical))
- Cognitive assessment(Pre-treatment)
- Mobility Scores(Pre-treatment)
- PROMIS Depression(from the treatment assessment until 12 months after the treatment (surgical or not-surgical))
- PROMIS Anxiety(from the treatment assessment until 12 months after the treatment (surgical or not-surgical))
- Patient Activation Measure (PAM)-10(from the treatment assessment until 12 months after the treatment (surgical or not-surgical))
- RUSH score(from the 6-8 weeks until 12 months after the treatment (surgical or not-surgical))
- RUST score(from the 6-8 weeks until 12 months after the treatment (surgical or not-surgical))
- Numeric Rating Scale (NRS) Pain(from the treatment assessment until 12 months after the treatment (surgical or not-surgical))