Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867018
Status:
WITHDRAWN
Last Update Posted:
2022-03-09
First Post:
2021-03-19
Brief Title:
Defining the Pathophysiology of Heterotopic Ossification A Prospective Study
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Defining the Pathophysiology of Heterotopic Ossification A Prospective Study
Status:
WITHDRAWN
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study was never fully reopened with the intuitional review board
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 midshaftdistal femur fracture humerus fracture proximal radius fracture and elbow dislocationfractures 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
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 midshaftdistal femur fracture humerus fracture proximal radius fracture and elbow dislocationfractures 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
Detailed Description:
The aforementioned general inclusionexclusion 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 PTINR 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
Tissue Samples Intraoperatively investigators will request a tissue sample of the debrided injured muscle from the area where the surgeon is operating There will be no additional tissue sample taken during the surgery but what is removed in the normal course of the operation will be used for analysis in our study The amount of tissue that will be analyzed for this study will vary based on how much of the injured muscle the operating physician decides to take in their normal course of operation If the tissue sample is not readily accessible such as in the case of an intramedullary nail fixation the investigators will forgo the sample
Follow-up
Radiographic imaging and notes from follow-up appointments will be examined for complications such as malunion nonunion infection hardware failure removal of hardware presence of amorphous tissue calcification symptomatic HO or asymptomatic HO Time to the development of calcific complications will also be recorded To document post-surgical complications the investigators will use imaging photographs progress notes clinic notes ICD-9 codes CPT codes and operative reports
The time frame for follow up visits will be based on the preference of the participants physician Any complications resulting from the injury will be documented Complications will be documented if they occur within 2 years of injury No study activities will take place during this time frame other than recording complications
Clinical Practice Guidelines
All patients will be treated according to established clinical practice guidelines at Vanderbilt Childrens Hospital or Vanderbilt Medical Center decreasing the chance that differences in the patients results and outcomes result from variability of the treating physician
Arm 2 Volunteers Blood Draw Blood will be taken from healthy nonpregnant adults who weigh at least 110 pounds All volunteers will have a single blood draw of 100ml at the time of consent No more than 25 of the volunteers blood volume will be taken at any point 100ml maximum for a 110lb person in one sitting
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 PTINR 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
Tissue Samples Intraoperatively investigators will request a tissue sample of the debrided injured muscle from the area where the surgeon is operating There will be no additional tissue sample taken during the surgery but what is removed in the normal course of the operation will be used for analysis in our study The amount of tissue that will be analyzed for this study will vary based on how much of the injured muscle the operating physician decides to take in their normal course of operation If the tissue sample is not readily accessible such as in the case of an intramedullary nail fixation the investigators will forgo the sample
Follow-up
Radiographic imaging and notes from follow-up appointments will be examined for complications such as malunion nonunion infection hardware failure removal of hardware presence of amorphous tissue calcification symptomatic HO or asymptomatic HO Time to the development of calcific complications will also be recorded To document post-surgical complications the investigators will use imaging photographs progress notes clinic notes ICD-9 codes CPT codes and operative reports
The time frame for follow up visits will be based on the preference of the participants physician Any complications resulting from the injury will be documented Complications will be documented if they occur within 2 years of injury No study activities will take place during this time frame other than recording complications
Clinical Practice Guidelines
All patients will be treated according to established clinical practice guidelines at Vanderbilt Childrens Hospital or Vanderbilt Medical Center decreasing the chance that differences in the patients results and outcomes result from variability of the treating physician
Arm 2 Volunteers Blood Draw Blood will be taken from healthy nonpregnant adults who weigh at least 110 pounds All volunteers will have a single blood draw of 100ml at the time of consent No more than 25 of the volunteers blood volume will be taken at any point 100ml maximum for a 110lb person in one sitting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None