Improved Treatment of Distal Radius Fractures Using an Image-Guided, Percutaneous Delivery of a Novel Bone Adhesive

使用图像引导、经皮输送新型骨粘合剂改善桡骨远端骨折的治疗

• 批准号: 10380629
• 负责人: Brian Hess
• 金额: $ 62.45万
• 依托单位: REVBIO, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10380629
• 关键词: Address; Adhesives; Animal Model; Animals; Annual Reports; Barium; Biocompatible Materials; Bone Cements; Bone remodeling; Cadaver; Carpal Tunnel Syndrome; Case Study; Chemistry; Clinical; Complement; Complex; Complex Regional Pain Syndromes; Complication; Compression Fracture; Contrast Media; Development; Devices; Distal; Elderly; Evaluation; Failure; Fluoroscopy; Formulation; Fracture; Funding; Government; Hand; High Prevalence; Histology; Hospitals; Human; Infection; Inferior; Injections; Injury; Investigation; Lead; Mechanics; Medical; Medicare; Metals; Metatarsal bone structure; Mission; Modeling; Monitor; Open Fractures; Operating Rooms; Operative Surgical Procedures; Orthopedics; Osteoporosis; Osteoporotic; Outcome Study; Patients; Performance; Persons; Phase; Procedures; Property; Publishing; Quality of life; Radial; Radius Fractures; Reporting; Research; Rupture; Sampling Studies; Sheep; Surgeon; Technology; Tendon structure; Testing; Time; Translations; Trauma; Upper Extremity; aged; aging population; base; biomechanical test; bone; bone healing; cone-beam computed tomography; falls; healing; image guided; improved; in vivo; innovation; irritation; mechanical properties; mortality; novel; older patient; payment; phase 2 study; primary outcome; procedure cost; research and development; sample fixation; scaffold; standard of care; standing height; usability

Project Abstract/Summary Falls from standing height and other low-energy trauma account for 87% of all orthopedic fractures among the elderly. Distal radius fractures (DRF) are one of the most common types of these fractures, with approximately 40% of the more than 675,000 DRF cases reported annually in the U.S. occurring in people aged 65 years or older. Unfortunately, these injuries result in difficulty performing the most basic daily tasks and, for elderly patients, can lead to a loss of independence, a reduction in quality of life, and even increased mortality. The current standard of care for DRF injuries is open reduction internal fixation (ORIF) procedures that involve placement of metal hardware such as volar plates and/or K-wires. Results of these open surgical approaches have been mixed; complication rates have been reported to be as high as 36% in the elderly and involve the onset of carpal tunnel syndrome, complex regional pain syndrome, and have led to tendon irritation and rupture, deep infections, and the need to re-operate to remove the plates. To address this issue LaunchPad Medical (LPM) has developed Tetranite® (TN), a novel bone adhesive biomaterial that can bond bone fragments together, fill bone voids, and adhere bone to metal. Over time this innovative material acts as a scaffold, promoting healing and allowing bone to grow through it to ultimately replace it with new, vital bone. TN’s robust bond strength, when subjected to shear loading to the various substrates, has been shown to be significantly greater than non-adhesive bone cements on the market. Yet when properly mixed, TN’s flow properties make it ideal for percutaneous delivery. Uniquely, TN can be loaded with BaSO4 without significant degradation to its mechanical properties, making it possible for a surgeon to monitor its placement in vivo via fluoroscopy in real time and without the need for open surgery. In Phase I of this project the TN adhesive chemistry was characterized and optimized to yield a product with sufficient mechanical and microstructural properties to fixate upper extremity bone fractures on a stand-alone basis (without the use of metal fixation hardware). Preliminary cadaver studies have demonstrated the effective percutaneous treatment using the optimized formulation. Building on this successful Phase I project, and other preliminary R & D, TN’s translation to a clinical indication for treating DRF injuries will continue in the proposed Phase II study through the completion of the following: Aim 1: Optimization of the Percutaneous Delivery of TN for DRF Procedures and Aim 2: Demonstration of the Safe and Effective Use of TN in a Large Animal Study. The results from this translational animal study, complemented with surgeon validated simulated use cadaver testing, will be used to as the basis for filing an Investigational Device Exemption (IDE) with the FDA to initiate human studies. Long term, LPM’s mission is to provide surgeons with a novel product that will enhance fixation, reduce complications and revision surgeries associated with DRF procedures in the elderly.

项目摘要/总结