Custom Energy-Storing Carbon Fiber Orthosis for Lower-Limb Trauma: Can the Results Be Obtained Outside the Designing Center?

Commentary In this study, the authors looked at the effect of an exoskeletal orthosis and physiotherapy on patient-reported outcomes after unilateral traumatic lower-extremity injury. The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom-fitted, energy-storing ankle-foot orthosis (AFO). This, combined with the Return to Run Physical Therapy (RTR PT) program, has been demonstrated to improve patient-reported outcomes. The authors wanted to confirm that the gains were maintained at 12 months and could be reproduced at other military treatment facilities. The authors recruited 87 service members who were at least 1 year out from a unilateral lower-extremity injury and had functional deficits. Evaluations took place before the orthosis was fitted, immediately after physiotherapy, and at 6 and 12 months following program completion. Primary outcomes were functional performance as measured by agility, strength and power, and speed tests. Eighty-one participants, including 42 at a different treatment facility than the designing facility, completed physiotherapy and reported early outcomes. Secondary outcomes included the OPUS (Orthotics and Prosthetics Users’ Survey) and Short Musculoskeletal Function Assessment (SMFA). The follow-up rates immediately following physiotherapy and at 6 and 12 months were 88%, 75%, and 79%, respectively. The authors observed that the functional outcomes were improved after the completion of physiotherapy with the brace in all performance tests except 1. Satisfaction with the brace was high. The authors concluded that the energy-storing AFO and the physiotherapy program can be reproduced in other facilities, although the patients still reported lower scores than normal for the general patient population. Previously this device was shown to have benefits compared with below-the-knee amputation1, but without a randomized controlled trial, these groups may not be comparable. When I read this paper and consider the applicability of its findings to my practice, I have difficulty because I have little idea of the limb pathology that is being treated, although the demographics of the patients being treated were very clear. In other words, I have no idea which of my patients would be the most suitable candidates for the energy-storing AFO. Are these patients with ankle instability or complex trauma? Patients listed in a table include patients with loss of ankle dorsiflexion or plantar flexion from weakness, candidates for fusion or those having had fusion, patients with loss of range of motion, or those considered for amputation. This is clearly a very diverse group of patients who have in common a military career, an injury, and involvement of 1 limb only with foot and ankle pathology. The injury population is therefore not clearly defined, and it is difficult to see how this technology and physiotherapy would fit outside the military. This is also recognized by the authors in their discussion. The benefit of this energy-storing AFO over another prosthesis and physiotherapy is not outlined. Is it clearly better2? Most patients report the benefit of physiotherapy and of bracing, and often the cost of a custom prosthesis in regular civilian practice may not give enough benefit compared with surgery. I have concern that the device is identified by trade name and trademark instead of a generic name. The trade name is promoted 7 times in the abstract alone in this paper. I look forward to more papers from this group to see if this is clearly a functional breakthrough, or is just another expensive brace. A randomized controlled trial would be required to tell the difference. Better defining of patient population in future papers, including what precisely is the indication for the device, would help. While this may be obvious to a U.S. military physician, it is not clear to me or likely other surgeons and physicians who are in nonmilitary practice; for example, which of my patients would use the brace, how is the expense justified, and what is the exact patient benefit? This could be an important breakthrough, but proper independent research will tell if this is the case.

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