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Internal Lengthening Device for Congenital Femoral Deficiency and Fibular Hemimelia

  • Symposium: 2013 Limb Lengthening and Reconstruction Society
  • Published:
Clinical Orthopaedics and Related Research®

Abstract

Background

Patients with congenital limb shortening can present with joint instability, soft tissue contractures, and significant leg length discrepancy. Classically, lengthening is done with external fixation, which can result in scarring, pin site infection, loss of motion, and pain. We therefore developed an alternative to this approach, a new, controllable, internal lengthening device for patients with congenital limb shortening.

Questions/purposes

We evaluated this device in terms of (1) healing index, (2) complications, (3) accuracy of the device’s external controller, and (4) adjacent-joint ROM.

Methods

Between January 2012 and May 2013, we treated 66 patients for congenital limb shortening, of whom 21 were treated using this device. During this period, general indications for using the device were patients with leg length discrepancies of 2 cm or more, with intramedullary canals able to withstand rods of at least 12.5-mm diameter and 230-mm length, without active infection in the affected bone, able to comply with the need for frequent lengthening, and without metal allergies or an implanted pacemaker. We included only those patients who had completed their course of treatment and were currently fully weightbearing, leaving 18 patients (21 bone segments) available for followup at a minimum of 6 months after limb lengthening (mean, 14 months; range, 6–22 months). Mean age was 19 years (range, 9–49 years). Sixteen femurs and five tibias were lengthened a mean of 4.4 cm (range, 2.1–6.5 cm). Mean distraction index was 1.0 mm/day (range, 0.5–1.8 mm/day). Healing index, complications, device accuracy, and ROM were recorded. To date, 10 of the 21 devices have been removed. This was typically done 12–24 months after insertion when the bone was solidly healed on all four cortices.

Results

Mean healing index was 0.91 months/cm (range, 0.2–2.0 months/cm). There were seven complications requiring an additional unplanned surgery, including one hip flexion contracture, three femurs with delayed healing, one tibia with delayed healing, one hip subluxation/dislocation, and one knee subluxation. The external controller was accurate as programmed and actual lengthening amounts were consistent. ROMs of the hip, knee, and ankle were essentially maintained.

Conclusions

This device is completely internal, allowing for satisfactory joint motion during treatment in most patients. Lengthening was achieved in an accurate, controlled manner, and all patients reached their goal length. Complications remain a concern, as is the case with all approaches to this complex patient population. Both future comparative studies and longer-term followup are needed.

Level of Evidence

Level IV, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

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Fig. 1A–C
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Acknowledgments

The authors thank Kristina Kotze BS for her help with data collection and entry.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to John E. Herzenberg MD.

Additional information

The institution of the authors has received, during the study period, funding from Ellipse Technologies, Inc (Irvine, CA, USA), the company who makes the telescopic intramedullary rods used in study patients. The institution of the authors also receives funding for our annual fundraiser (Save-A-Limb ride) from Stryker Orthopaedics (Mahwah, NJ, USA), Medtronic (Minneapolis, MN, USA), Integra LifeSciences Corp (Plainsboro, NJ, USA), Medevations LLC (Bel Air, MD, USA), Supreme Orthopedic Systems, Inc (Marriottsville, MD, USA), Biomet, Inc (Warsaw, IN, USA), Metro Prosthetics Inc (Landover Hills, MD, USA), and OHK Medical Devices Ltd (Grandville, MI, USA) and for our annual course (Baltimore Limb Deformity Course) from Smith & Nephew, Inc (Memphis, TN, USA), BrainLab Inc (Westchester, IL, USA), Orthofix Inc (Lewisville, TX, USA), Synthes, Inc (West Chester, PA, USA), Stryker Orthopaedics, Wright Medical Technology, Inc (Arlington, TN, USA), Biomet, Inc, and The MHE Coalition.

One of the authors (SCS) certifies that he, or a member of his immediate family, has received or may receive payments or benefits, during the study period, an amount of USD 10,000 to USD 100,000, from Ellipse Technologies, Inc.

One of the authors (JEH) certifies that he, or a member of his immediate family, has received or may receive payments or benefits, during the study period, an amount of les than USD 10,000, from Ellipse Technologies, Inc.

The remaining authors certify that they, or a member of their immediate family, have no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangement, etc) that might post a conflict of interest in connection with the submitted article.

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research ® editors and board members are on file with the publication and can be viewed on request.

Clinical Orthopaedics and Related Research ® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA approval status, of any drug or device before clinical use.

Each author certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.

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Shabtai, L., Specht, S.C., Standard, S.C. et al. Internal Lengthening Device for Congenital Femoral Deficiency and Fibular Hemimelia. Clin Orthop Relat Res 472, 3860–3868 (2014). https://doi.org/10.1007/s11999-014-3572-3

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  • DOI: https://doi.org/10.1007/s11999-014-3572-3

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