A Multicenter, Randomized, Controlled, Blinded Study of the Efficacy and Safety of Bone Healing Accelerant Versus Standard of Care in Subjects With Open Tibia Fractures
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Tibial Fractures
- Sponsor
- Carmell Therapeutics Corporation
- Locations
- 1
- Primary Endpoint
- Composite healing measure
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible to participate in this study, subjects must meet all of the following 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.
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. Examples include but are not limited to the following:
- •Head injury with impaired cognitive function,
- •Spinal injury with resultant neurologic weakness or paralysis,
- •Multi-trauma requiring prolonged hospitalization or recovery that, in the opinion of the investigator, the treatment and/or rehabilitation of such injuries will substantially interfere with the treatment, rehabilitation or other requirements outlined in this protocol,
Outcomes
Primary Outcomes
Composite healing measure
Time Frame: 6 months
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 Outcomes
- Radiographic healing(6 months)
- Secondary intervention (surgical or nonsurgical)(6 months)
- Surgical site infection(12 months)