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.
Between October 2001 and September 2009 we lengthened 242 lower-limb segments in 180 patients using the Intramedullary Skeletal Kinetic Distractor (ISKD). Mechanical failure was defined either as breakage of the ISKD or failure of the internal mechanism to activate. Retrieved nails which failed mechanically were examined by the manufacturer for defects. In all, 15 ISKDs in 12 patients (13 limbs) failed mechanically representing an overall failure rate of 6.2%, with fracture of the device occurring in ten of the 15 failures. Two nails in one patient failed to lengthen and had to be replaced. The manufacturer detected an error in the assembly of the nail, which prompted a wide recall. One nail jammed after being forcefully inserted, and two nails failed to lengthen fully. Lengthening was achieved in all 12 patients, although three required a second operation to exchange a defective nail for a new, functioning device. The ISKD is a complex mechanical device which lengthens by the oscillation of two telescopic sections connected by a threaded rod. The junction between these sections is surrounded by a keyring collar. This keyring collar is the weakest part of the device.
The Ponseti method has become the gold standard for the treatment of idiopathic clubfoot. Its safety and efficacy has been demonstrated extensively in the literature, leading to increased use around the world over the last two decades. This has been demonstrated by the increase in Ponseti related PubMed publications from many countries. We found evidence of Ponseti activity in 113 of 193 United Nations members. The contribution of many organizations which provide resources to healthcare practitioners in low and middle income countries, as well as Ponseti champions and modern communication technology, have helped to spread the Ponseti method around the world. Despite this, there are many countries where the Ponseti method is not being used, as well as many large countries in which the extent of activity is unknown. With its low rate of complication, low cost, and high effectiveness, this method has unlimited potential to treat clubfoot in both developed and undeveloped countries. Our listing of countries who have not yet shown presence of Ponseti activity will help non-governmental organizations to target those countries which still need the most help.
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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