Defining the Pathophysiology of Heterotopic Ossification: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change of inflammation from baseline during hospitalization as measured by IL-6
研究概览
简要总结
Our overarching aim is to define the pathophysiology, epidemiology, and natural history of HO by following patients from date of injury until full wound healing has occurred and the window for HO has passed.
Specific aims
Aim 1: To classify the acute and chronic physiologic profiles of fracture patients and how they relate to the development of HO. Here the investigators will look at the systemic derangements to patients' coagulation, fibrinolytic, and inflammatory profiles.
Aim 2: Identify the true incidence and time course of HO development after traumatic fracture. To accomplish this the investigators will look at patients who have sustained hip fracture, midshaft/distal femur fracture, humerus fracture, proximal radius fracture, and elbow dislocation/fractures and track follow-up images up to one year after injury looking for HO.
Aim 3: Define the histologic characteristics of HO development. To accomplish this aim the investigators will perform a histologic analysis on a sample of injured muscle surrounding the fracture area.
Aim 4: To determine what comorbid, iatrogenic, or environmental influences are associated with the formation of HO. To achieve this aim the investigators will evaluate data including injury type, surgery type, operative duration, surgical approach, contamination (open vs closed injury), complications (malunion, nonunion, infection, hardware failure, removal of hardware), hardware type, comorbidities (smoking, cardiac history, diabetes), and medications.
详细描述
The aforementioned general inclusion/exclusion criteria will be used to determine patient eligibility. All eligible patients will be identified using a patient list from StarPanel provided by the managing team. The study will proceed until all eligible patients are enrolled (our goal for this study is to recruit at least 1000 patients). If the patient agrees to participate in the study they will be asked to sign an informed consent document by the research team.
Arm 1
On Admission:
Demographics and Comorbidities The following patient data will be recorded: age, gender, height, weight, date of admission, date of discharge, diagnosis, injury time, injury type, laterality, surgical approach, implants used, duration of surgery, time to union, contamination (open vs closed injury), comorbidities (smoking, cardiac history, diabetes, etc.), current medications.
Labs Patients will have an additional 9ml of blood drawn during their normal course of care for this study up to 4 times. The draws will happen while they are an inpatient in the hospital. The timing of the draw will surround the timing of their operation. They will have blood drawn within 24 hours before surgery, immediately after surgery, 24 hours after surgery, and 72 hours after surgery. Labs values, including CBC with dif, CMP, D-Dimer, CRP, PT/INR, PTT, fibrinogen, lactate, PAI-1, plasminogen activation assay, chromogenics, plasmin-anti-plasmin complex, and phosphate will be collected for this study. Patient often have a blood draw before and after surgery, one for typing and another as part of routine labs. The investigators will use the remnants of those blood draws which will be stored in the Vanderbilt Lab core and retrieved for further analysis by key research personnel. The remaining plasma will come from another remnant blood or an extra draw.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient treated in our hospital system from initial IRB approval until we reach our enrollment quota that are diagnosed with HO, hip fracture, midshaft/distal femur fracture, humerus fracture, proximal radius fracture, and elbow dislocation/fracture. This includes patients in all age groups and of all genders.
- •Patients with a diagnosis of HO, hip fracture, midshaft/distal femur fracture, humerus fracture, proximal radius fracture, or elbow fracture must be receiving operative treatment for their injury.
- •Patients with concurrent trauma will be grouped into a sub-analysis.
排除标准
- •Patients with pathologic fractures.
- •Non-operative patients other than elbow dislocation patients
- •Pregnant Women
- •Patients who do not intend to follow-up at Vanderbilt
- •Arm 2- Healthy Volunteers
- •Inclusion Criteria:
- •Volunteers (male or female) between ages of 18-70
- •Weight greater than 110lbs
- •Exclusion Criteria:
- •Chronic medical conditions such as diabetes, hypertension, high cholesterol, rheumatologic disorders, infections, etc.
- •History of recent trauma or burn injury
- •Recent inpatient admission within the last year
- •Pregnant females or people on hormone replacement therapy
- •People on any anticoagulant medication or NSAIDS
结局指标
主要结局
Change of inflammation from baseline during hospitalization as measured by IL-6
时间窗: Change of IL-6 from baseline and during hospitalization (approximately 1-28 days)
The normal range for IL-6 is 0-5pg/mL or \<15pg/mL. An increase in IL-6 will indicate activation of inflammation.
Change of coagulation from baseline during hospitalization as measured by platelet count
时间窗: Change of platelet count from baseline and during hospitalization (approximately 1-28 days)
The normal platelet count range is 150,000-450,000/uL. Typically a decrease in platelet count is associated with activation of coagulation, and increases represent a rebound reparative period. This is not always the case, so we will record both increases and decreases in platelet count, specifically.
Change of coagulation from baseline during hospitalization as measured by thrombin-antithrombin (TAT) complexes
时间窗: Change of thrombin-antithrombin (TAT) from baseline and during hospitalization (approximately 1-28 days)
The normal range for thrombin-antithrombin (TAT) complexes is 1-4 ug/L. An increase in thrombin-antithrombin (TAT) complexes will indicate activation of coagulation.
Change of inflammation from baseline during hospitalization as measured by C-reactive protein (CRP)
时间窗: Change of C-reactive protein (CRP) from baseline and during hospitalization (approximately 1-28 days)
The normal range for C-reactive protein (CRP) is \<10mg/L. An increase in C-reactive protein (CRP) will indicate activation of inflammation.
Change of fibrinolysis from baseline during hospitalization as measured by plasmin-antiplasmin complex (PAP)
时间窗: Change of plasmin-antiplasmin complex (PAP) from baseline and during hospitalization (approximately 1-28 days)
The normal range for Plasmin-antiplasmin complex (PAP) is 120-700ug/L. An increase in plasmin-antiplasmin complex (PAP) will indicate activation of fibrinolysis.
Change of fibrinolysis from baseline during hospitalization as measured by D-dimer
时间窗: Change of D-dimer from baseline and during hospitalization (approximately 1-28 days)
The normal range for D-dimer is \<0.5mg/L. An increase in D-dimer will indicate activation of fibrinolysis.
次要结局
未报告次要终点
研究者
Jon Schoenecker
Associate Professor Of Orthopaedics, Pathology, Pharmacology, and Pediatrics
Vanderbilt University Medical Center