PMS18 The Direct and Indirect Costs of Long Bone Fractures in a Working Age U.S. Population

Abstract Background Overall, 5–10% of fractures result in delayed unions or non-unions, causing major disabilities and a huge socioeconomic burden. Since rescue surgery with autologous bone grafts can cause additional challenges, alternative treatment options have been developed to stimulate a deficient healing process. This study assessed the technical feasibility, safety and preliminary efficacy of local percutaneous implantation of allogeneic bone-forming cells in delayed unions of long bone fractures. Methods In this phase I/IIA open-label pilot trial, 22 adult patients with non-infected delayed unions of long bone fractures, which failed to consolidate after 3 to 7 months, received a percutaneous implantation of allogeneic bone-forming cells derived from bone marrow mesenchymal stem cells (ALLOB; Bone Therapeutics) into the fracture site (50 × 106 to 100 × 106 cells). Patients were monitored for adverse events and need for rescue surgery for 30 months. Fracture healing was monitored by Tomographic Union Score (TUS) and modified Radiographic Union Score. The health status was evaluated using the Global Disease Evaluation (GDE) score and pain at palpation using a visual analogue scale. The presence of reactive anti-human leukocyte antigen (HLA) antibodies was evaluated. Results During the 6-month follow-up, three serious treatment-emergent adverse events were reported in two patients, of which two were considered as possibly treatment-related. None of the 21 patients in the per-protocol efficacy population needed rescue surgery within 6 months, but 2/21 (9.5%) patients had rescue surgery within 30 months post-treatment. At 6 months post-treatment, an improvement of at least 2 points in TUS was reached in 76.2% of patients, the GDE score improved by a mean of 48%, and pain at palpation at the fracture site was reduced by an average of 61% compared to baseline. The proportion of blood samples containing donor-specific anti-HLA antibodies increased from 8/22 (36.4%) before treatment to 13/22 (59.1%) at 6 months post-treatment, but no treatment-mediated allogeneic immune reactions were observed. Conclusion This pilot study showed that the percutaneous implantation of allogeneic bone-forming cells was technically feasible and well tolerated in patients with delayed unions of long bone fractures. Preliminary efficacy evidence is supporting the further development of this treatment. Trial registration NCT02020590. Registered on 25 December 2013. ALLOB-DU1, A pilot Phase I/IIa, multicentre, open proof-of-concept study on the efficacy and safetyof allogeneic osteoblastic cells (ALLOB®) implantation in non-infected delayed-union fractures.

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The Photodynamic Bone Stabilization System: a minimally invasive, percutaneous intramedullary polymeric osteosynthesis for simple and complex long bone fractures

Medical Devices Evidence and Research ◽

10.2147/mder.s71790 ◽

2014 ◽

pp. 453 ◽

Cited By ~ 2

Author(s):

Jeff Muir ◽

Paul Vegt ◽

Jon Block

Keyword(s):

Minimally Invasive ◽

Bone Fractures ◽

Long Bone ◽

Stabilization System ◽

System A ◽

Long Bone Fractures

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Comparison of Mechanical Stability of Elastic Titanium, Nickel-Titanium, and Stainless Steel Nails Used in the Fixation of Diaphyseal Long Bone Fractures

Materials ◽

10.3390/ma11112159 ◽

2018 ◽

Vol 11 (11) ◽

pp. 2159 ◽

Cited By ~ 1

Author(s):

Pei-Yuan Lee ◽

Yen-Nien Chen ◽

Jin-Jia Hu ◽

Chih-Han Chang

Keyword(s):

Stainless Steel ◽

Mechanical Stability ◽

Fe Simulation ◽

Bone Fractures ◽

Nickel Titanium ◽

Long Bone ◽

Bone Modeling ◽

Long Bone Fractures ◽

Elastic Nails ◽

The Difference

Elastic nails made of the nickel-titanium shape memory alloy (Nitinol) have been reported to control bone modeling in animal studies. However, the mechanical stability of the Nitinol nail in the fixation of long bone fractures remains unclear. This study compared mechanical stability among nails made of three materials, namely Nitinol, titanium, and stainless steel, in the fixation of long bone fractures. These three materials had identical shapes (arc length: π/2 and radius: 260 mm). A cylindrical sawbone with a 10-mm gap and fixed with two C-shaped elastic nails was used to examine the stability of the nails. A finite element (FE) model was developed based on the sawbone model. The end cap for elastic nails was not used in the sawbone test but was considered based on a constraint equation in FE simulation. The results of stability tests appeared to depend on the presence or absence of the end cap. In the sawbone test, the titanium nail yielded a higher ultimate force against the applied load than did the stainless steel and Nitinol nails before the gap completely closed; the difference in linear stiffness between the nails was nonsignificant. In FE simulation, the titanium nail produced smaller gap shortening than did stainless steel and Nitinol nails without the end cap; the difference in gap shortening between the nails was minor with the end cap. The titanium elastic nail should be a better choice in managing diaphyseal long bone fractures when the end cap is not used. For Nitinol and stainless steel nails, the end cap should be used to stop the nail from dropping out and to stabilize the fractured bone.

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