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Multiregion BHA in Open Tibia Fractures

Primary Purpose

Tibial Fractures

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BHA
Sponsored by
Carmell Therapeutics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient is between the ages of 18-75 inclusive at time of randomization. Patient has an acute open Gustilo-Anderson Type IIIA or IIIB fracture of the tibia shaft, with or without a fibula fracture, secondary to trauma.

Patient received antibiotic treatment within 2 hours of presentation at initial medical facility.

Patient underwent their first operative debridement within 24 hours of presentation at initial medical facility.

Patient is scheduled to have DWC within 14 days of initial injury. The tibia fracture requires open fracture reduction and internal fixation with intramedullary (IM) nailing;

- IM nailing has been cross-locked for stability with a 4-5mm interlock, with a minimum of 1 static screw above the fracture site and 1 static screw below the fracture site, and All IM nails have a diameter between 8.5-12mm with 1.0-1.5mm over-reaming of the canal.

The temporary use of external fixation prior to IM rodding and DWC is allowed.

Upon stabilization of the tibia fracture, the patient has a cortical deficit of less than or equal to 1.0cm involving no more than 50% of the tibia circumference. The cortical deficit of the residual 50% circumference must be less than 1.0cm. Gap assessments to be made with calibrated radiographs or visual inspection. In addition, patients are not likely to require a secondary procedure(s) to promote bone healing.

BHA is able to be applied through existing soft tissue defects created by the injury or those created during surgical treatment. No new incisions should be required specifically for application of BHA.

Patient is willing and able to comply with all study procedures including all pre-operative, post-operative and rehabilitation requirements.

Patient is able to give voluntary IC to participate and has signed an IC form specific to this study prior to study treatment and DWC.

Patients of childbearing potential must use adequate methods of contraception during the duration of follow-up (12-months). Adequate methods include abstinence, female and male sterilization, hormonal contraceptives, intrauterine devices (IUDs), implants, injectables, and double barrier methods.

Exclusion Criteria:

Patients who are currently participating in another investigational trial or having participated in a clinical investigation within the last 90 days or intend to during the course of the study.

Patients who are currently prisoners. Patients who are unable to give informed consent. Patients who are skeletally immature (<18 years of age or radiographic evidence of open tibial physes).

Patients with Type I, II, or IIIC open tibia fractures according to the Gustilo-Anderson classification.

Current injury is a pathological fracture. Patients with additional injuries that could impact their ability to complete the required assessments and postoperative rehabilitation.

Patients with immune deficiency or history of auto-immune disease.

Patients with an active malignancy or a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years.

Patients with any medical condition or life circumstances that in the surgeon's opinion could impact their ability to return for follow-up visits and/or complete the required assessments and postoperative rehabilitation.

Patients who are known to have anaphylactic or severe systemic reaction to human blood products, genipin, β-TCP, glycerin or to other components of the investigative product formulation.

Female patients of child-bearing potential who meet any of the following criteria:

Patient is currently pregnant (prior diagnosis or a positive pregnancy test at baseline), or planning to become pregnant any time during the course of the study Currently breastfeeding or planning to breastfeed at any time during the course of the study Upon stabilization of the tibia fracture, the patient has a bone gap greater than 1.0cm apparent by calibrated radiographs or by visual inspection and/or the patient is highly likely to require secondary intervention procedure(s), surgical or nonsurgical (e.g., bone stimulation or ultrasound treatment) for the index fracture.

Patients who have mal-alignment post-IM nailing of >10° in the coronal plane or >15° in the sagittal plane.

Patients who received only plates and screws for tibia fracture stabilization. At the time of the DWC surgery, patients who have a planned secondary intervention procedure, surgical or nonsurgical (e.g., bone stimulation or ultrasound treatment) for the index fracture.

Patients being treated with any form of local antibiotics at the time of DWC.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    BHA

    Control

    Arm Description

    Subjects treated with BHA + standard of care

    Subjects treated as per standard of care

    Outcomes

    Primary Outcome Measures

    Composite healing measure
    Proportion of subjects in each arm meeting the healing success criteria. A binary (Yes/No) outcome for overall healing will be derived from the following three outcomes: Radiographic healing as measured by a score of at least 13 on the modified Radiographic Union Scale in Tibia fractures (mRUST, range bad to good 1-16), ambulation as measured by a score of at least 2 on the Function IndeX for Trauma scale (range bad to good 0-3), and no secondary intervention to promote bone healing. All three components must be met for a "yes" on composite healing.

    Secondary Outcome Measures

    Radiographic healing
    Population mean Modified Radiographic Union Scale in Tibia Fractures (mRUST) scores (range bad to good is 4-16)
    Secondary intervention (surgical or nonsurgical)
    Proportion of subjects not having secondary intervention conducted specifically to promote bone healing needed
    Surgical Site Infection
    Proportion of subjects having surgical site infection through 12 months as determined by CDC guidelines

    Full Information

    First Posted
    August 12, 2019
    Last Updated
    January 21, 2020
    Sponsor
    Carmell Therapeutics Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04056429
    Brief Title
    Multiregion BHA in Open Tibia Fractures
    Official Title
    A Multiregion, Randomized, Controlled, Blinded Study of the Safety and Efficacy of Bone Healing Accelerant Versus Standard of Care in Subjects With Open Tibia Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2020 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    September 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Carmell Therapeutics Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This clinical study is being conducted to demonstrate the safety and effectiveness of the Bone Healing Accelerant (BHA) product when applied to tibia (leg bone) fractures with an external wound or skin break (also called open tibia fractures). It is hypothesized that by 6 months, the number of subjects with successful bone healing will be greater in the BHA-treated group compared to subjects treated with standard of care alone. Open tibia fractures were chosen for this study because healing rates are typically longer than for other bone fractures due to the limited vascular supply, limited soft tissue coverage, and higher risk of infection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tibial Fractures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    220 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BHA
    Arm Type
    Experimental
    Arm Description
    Subjects treated with BHA + standard of care
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Subjects treated as per standard of care
    Intervention Type
    Combination Product
    Intervention Name(s)
    BHA
    Intervention Description
    BHA active ingredients include beta-tricalcium phosphate and a blood-derived component. It is applied directly to the bone fracture and nearby viable bone at the time of wound closure.
    Primary Outcome Measure Information:
    Title
    Composite healing measure
    Description
    Proportion of subjects in each arm meeting the healing success criteria. A binary (Yes/No) outcome for overall healing will be derived from the following three outcomes: Radiographic healing as measured by a score of at least 13 on the modified Radiographic Union Scale in Tibia fractures (mRUST, range bad to good 1-16), ambulation as measured by a score of at least 2 on the Function IndeX for Trauma scale (range bad to good 0-3), and no secondary intervention to promote bone healing. All three components must be met for a "yes" on composite healing.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Radiographic healing
    Description
    Population mean Modified Radiographic Union Scale in Tibia Fractures (mRUST) scores (range bad to good is 4-16)
    Time Frame
    6 months
    Title
    Secondary intervention (surgical or nonsurgical)
    Description
    Proportion of subjects not having secondary intervention conducted specifically to promote bone healing needed
    Time Frame
    6 months
    Title
    Surgical Site Infection
    Description
    Proportion of subjects having surgical site infection through 12 months as determined by CDC guidelines
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient is between the ages of 18-75 inclusive at time of randomization. Patient has an acute open Gustilo-Anderson Type IIIA or IIIB fracture of the tibia shaft, with or without a fibula fracture, secondary to trauma. Patient received antibiotic treatment within 2 hours of presentation at initial medical facility. Patient underwent their first operative debridement within 24 hours of presentation at initial medical facility. Patient is scheduled to have DWC within 14 days of initial injury. The tibia fracture requires open fracture reduction and internal fixation with intramedullary (IM) nailing; - IM nailing has been cross-locked for stability with a 4-5mm interlock, with a minimum of 1 static screw above the fracture site and 1 static screw below the fracture site, and All IM nails have a diameter between 8.5-12mm with 1.0-1.5mm over-reaming of the canal. The temporary use of external fixation prior to IM rodding and DWC is allowed. Upon stabilization of the tibia fracture, the patient has a cortical deficit of less than or equal to 1.0cm involving no more than 50% of the tibia circumference. The cortical deficit of the residual 50% circumference must be less than 1.0cm. Gap assessments to be made with calibrated radiographs or visual inspection. In addition, patients are not likely to require a secondary procedure(s) to promote bone healing. BHA is able to be applied through existing soft tissue defects created by the injury or those created during surgical treatment. No new incisions should be required specifically for application of BHA. Patient is willing and able to comply with all study procedures including all pre-operative, post-operative and rehabilitation requirements. Patient is able to give voluntary IC to participate and has signed an IC form specific to this study prior to study treatment and DWC. Patients of childbearing potential must use adequate methods of contraception during the duration of follow-up (12-months). Adequate methods include abstinence, female and male sterilization, hormonal contraceptives, intrauterine devices (IUDs), implants, injectables, and double barrier methods. Exclusion Criteria: Patients who are currently participating in another investigational trial or having participated in a clinical investigation within the last 90 days or intend to during the course of the study. Patients who are currently prisoners. Patients who are unable to give informed consent. Patients who are skeletally immature (<18 years of age or radiographic evidence of open tibial physes). Patients with Type I, II, or IIIC open tibia fractures according to the Gustilo-Anderson classification. Current injury is a pathological fracture. Patients with additional injuries that could impact their ability to complete the required assessments and postoperative rehabilitation. Patients with immune deficiency or history of auto-immune disease. Patients with an active malignancy or a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years. Patients with any medical condition or life circumstances that in the surgeon's opinion could impact their ability to return for follow-up visits and/or complete the required assessments and postoperative rehabilitation. Patients who are known to have anaphylactic or severe systemic reaction to human blood products, genipin, β-TCP, glycerin or to other components of the investigative product formulation. Female patients of child-bearing potential who meet any of the following criteria: Patient is currently pregnant (prior diagnosis or a positive pregnancy test at baseline), or planning to become pregnant any time during the course of the study Currently breastfeeding or planning to breastfeed at any time during the course of the study Upon stabilization of the tibia fracture, the patient has a bone gap greater than 1.0cm apparent by calibrated radiographs or by visual inspection and/or the patient is highly likely to require secondary intervention procedure(s), surgical or nonsurgical (e.g., bone stimulation or ultrasound treatment) for the index fracture. Patients who have mal-alignment post-IM nailing of >10° in the coronal plane or >15° in the sagittal plane. Patients who received only plates and screws for tibia fracture stabilization. At the time of the DWC surgery, patients who have a planned secondary intervention procedure, surgical or nonsurgical (e.g., bone stimulation or ultrasound treatment) for the index fracture. Patients being treated with any form of local antibiotics at the time of DWC.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Clinical Science Department
    Phone
    (412) 894-8248
    Email
    info@carmellrx.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Janet M Vargo, PhD
    Phone
    (412) 894-8248
    Email
    jvargo@carmellrx.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janet M Vargo, PhD
    Organizational Affiliation
    Carmell Therapeutics
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Multiregion BHA in Open Tibia Fractures

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