Clinical Priority Program (CPP) Clinical Outcome Measurement of Fracture Treatment:
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Hip Fractures
- 发起方
- AO Innovation Translation Center
- 入组人数
- 1500
- 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
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
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 Objectives: 1. To identify the factors predictive of longer term magnitude of limitations after extremity fractures (using PROMs) 2. To assess minimal clinically important difference (MCID) and substantial clinical benefit (SCB) in PROM scores 3. To define recovery trajectories of PROMs i.e. range, normative limits and score thresholds III) Linking PROMIS®: Linking of PROMIS Measures to Legacy Measures in an Orthopaedic Patient Population Objectives: 1. Administer and collect responses to the PROMIS PF/UE and PAIN INT and the four orthopaedic legacy measures in the same group of orthopaedic trauma patients. 2. Apply the methods of item-response theory (IRT) linking to establish a common standardized metric. 3. Develop equations for conversion of a PROMIS PF/UE and PAIN INT score to each of the specified legacy measures and vice-versa.
研究者
入排标准
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
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))