Serum Protein Based Indices for the Progression of Fracture Healing and Non-Union

Grants and Contracts Details

Description

Obtain local IRB approval for the study protocol provided by the METRC Coordinating Center • Obtain Department of Defense Human Research Protections Office (DoD HRPO) approval • Participate in all required trainings on the study protocol and procedures • Obtain Coordinating Center certification • Maintain up-to-date master study documents including the protocol, standard operating procedures, informed consent, and case report forms (these are available by login on the METRC website) • Maintain up-to-date local study documents including standard operating procedures, delegation of authority logs, screening and enrollment logs, and event report documentation as required by the METRC Coordinating Center or by the local IRB • Screen patients ages18 to 70 (inclusive) receiving non-surgical treatment for a humerus fracture meeting inclusion and exclusion criteria as described in the study protocol. This includes completion of the screening case report form (CRF00) and entry of the form into the REDCap database. • Discuss the Union Biomarker study with potential participants who screen as eligible during their initial clinic/hospital visit. • Obtain and document Informed Consent, using appropriate/approved Informed Consent Forms from eligible patients who agree to participate in the study. • For enrolled patients, collect and enter baseline data into the REDCap database. • Evaluate participants at study visits scheduled at enrollment (1-2 weeks post fracture) and then at follow up (4-6, 7-9, 12-16, and 26 weeks post injury). Evaluations include assessment a 50mL blood draw at each visit, standard of care x-rays, documentation of complications, patient reported function and pain measures, range of motion, documentation of physical therapy. Enter follow-up data into the REDCap database. • Process and store blood specimens per the study SOP. • Ship blood specimens according to the schedule and processes detailed in the study SOP. • Respond to missing or incomplete data queries from the MCC • Obtain Continuing Review approval at the intervals specified by the local IRB and DoD HRPO • Obtain Master Protocol Amendment approval as necessary • Compensate participants $125 for completing all five study visits over the course of the 26-week follow up period
StatusActive
Effective start/end date9/30/199/29/24

Funding

  • Johns Hopkins University: $41,694.00

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