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PRECICE® magnetically-driven, telescopic, intramedullary lengthening nail: pre-clinical testing and first 30 patients

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      Abstract

      Introduction: Femoral/tibial lengthening with a telescopic, magnetically-powered, intramedullary nail is an alternative to lengthening with external fixation. Methods: Pre-clinical testing was conducted of the PRECICE in a human cadaver. A retrospective review of the first 30 consecutive patients who underwent unilateral lengthening was also conducted. Nail accuracy was obtained by comparing the amount of nail distraction to the final bone length achieved at the end of the distraction process. Relative standard deviation of accuracy was used to calculate nail precision. Results: Devices performed successfully in a human cadaver. Thirty consecutive patients (10 females, 20 males; mean age, 23 years) with limb length discrepancy (LLD) were followed an average of 19 months (range, 12–24 months). Etiology included congenital shortening (14), posttraumatic deformities (7), Ollier disease (3), osteosarcoma resection (1), prior clubfoot (2), hip dysplasia (1), post-septic growth arrest of knee (1), and LLD after hip arthroplasty (1). Twenty-four femoral and eight tibial nails were implanted. Mean preoperative lengthening goal was 4.4 cm (range, 2–6.5 cm); mean postoperative length achieved was 4.3 cm (range, 1.5–6.5 cm). Average consolidation index was 36.4 days/cm (range, 12.8–113 days/cm). Mean nail accuracy was 97.3% with a precision of 92.4%. Average preoperative and 12-month postoperative Enneking scores were 21.5 and 25.3 (p < 0.001), respectively. The preoperative and 12-month postoperative SF-12 physical and mental component scores were not statistically different. Nine complications (nine limb segments) resolved: two partial femoral unions, two suspected deep vein thrombosis (DVT), one delayed tibial union, one fibular nonunion, one peroneal nerve irritation, one knee joint subluxation, and one confirmed DVT. Twenty-nine (91%) of 32 limb segments achieved successful bone healing without revision surgery. Discussion: Limb lengthening with PRECICE is reliable, but larger trials with longer follow-up will reveal limitations. Implantable nails prevent problems associated with external fixation, such as muscle tethering and pin-site infections.

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      Femoral lengthening over an intramedullary nail. A matched-case comparison with Ilizarov femoral lengthening.

      Twenty-nine patients (thirty-two femora) had femoral lengthening over an intramedullary nail, with the nail and the external fixator applied concomitantly at the time of the femoral osteotomy. After gradual distraction at a rate of one millimeter per day, the nail was locked and the fixator was removed. The mean age was twenty-six years (range, ten to fifty-three years), and the mean amount of lengthening was 5.8 centimeters (range, two to thirteen centimeters). For comparison, thirty-one patients (thirty-two limbs) who had had standard Ilizarov femoral lengthening were matched with the group that had had lengthening over an intramedullary nail; the matching was performed on the basis of the amount of lengthening, the age of the patient, the etiology of the indication for lengthening, and the level of difficulty of the procedure. Lengthening over an intramedullary nail reduced the average duration of external fixation by almost one-half. The radiographic consolidation index (the number of months needed for radiographic consolidation for each centimeter of lengthening) for the limbs that had had lengthening over an intramedullary nail was reduced significantly (p < 0.001) compared with that for the matched-case group. The range of motion of the knee returned to normal a mean of 2.2 times faster in the group that had had lengthening over an intramedullary nail. There were six refractures of the distraction bone in the matched-case group. In the group that had had lengthening over an intramedullary nail, one nail and one proximal locking screw failed. The over-all rate of complications was 1.4 per cent in the group that had had lengthening over an intramedullary nail compared with 1.9 per cent in the matched-case group. With the numbers of patients available for study, we could not detect a significant difference between the groups with respect to the operative time (p = 0.124); however, the cost of treatment and the estimated blood loss were higher in the group that had had lengthening over an intramedullary nail. On the basis of clinical and radiographic criteria, there were twenty-three excellent, seven good, and two fair results in the group that had had lengthening over an intramedullary nail compared with twenty-six excellent, four good, and two fair results in the matched-case group (p = 0.37). The advantages of lengthening over an intramedullary nail include a decrease in the duration of external fixation, protection against refracture, and earlier rehabilitation.
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        A System for the Functional Evaluation of Reconstructive Procedures After Surgical Treatment of Tumors of the Musculoskeletal System

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          Clinical Application of the Tension-Stress Effect for Limb Lengthening

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            Author and article information

            Affiliations
            [1 ] Clinica Alemana de Santiago, Universidad del desarrollo Av. Vitacura 5951 Vitacura, Santiago Chile
            [2 ] Department of Orthopaedics, University Medical Center Hamburg-Eppendorf Martinistr 52 20246 Hamburg Germany
            [3 ] Pediatric Orthopaedic Department, Schön Klinik Harlaching Harlachinger Str 51 81457 Munich Germany
            [4 ] Department of Orthopedic Surgery, University of California Irvine CA USA
            [5 ] International Center for Limb Lengthening, Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore 2401 West Belvedere Ave Baltimore MD 21215 USA
            Author notes
            Journal
            SICOT J
            SICOT J
            sicotj
            SICOT-J
            EDP Sciences
            2426-8887
            2017
            06 March 2017
            : 3
            : ( publisher-idID: sicotj/2017/01 )
            29785927
            5962966
            10.1051/sicotj/2016048
            sicotj160103 10.1051/sicotj/2016048
            © The Authors, published by EDP Sciences, 2017

            This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

            Counts
            Figures: 2, Tables: 2, Equations: 0, References: 28, Pages: 7
            Categories
            Lower Limb
            Special Issue: "Deformity correction, limb lengthening and reconstruction" Guest Editor: Y. ElBatrawy
            Original Article

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