Precision of the PRECICE internal bone lengthening nail.

BACKGROUND: Previous designs of internal bone lengthening devices have been fraught with imprecise distraction, resulting in nerve injuries, joint contractures, nonunions, and other complications. Recently, a magnet-operated PRECICE nail (Ellipse Technologies, Inc, Irvine, CA, USA) was approved by the FDA; however, its clinical efficacy is unknown. QUESTIONS/PURPOSES: We evaluated this nail in terms of (1) accuracy and precision of distraction, (2) effects on bone alignment, (3) effects on adjacent-joint ROM, and (4) frequency of implant-related and non-implant-related complications. METHODS: We reviewed medical and radiographic records of 24 patients who underwent femoral and/or tibial lengthening procedures using the PRECICE nail from August 2012 to July 2013 for conditions of varied etiology, the most common being congenital limb length discrepancy, posttraumatic growth arrest, and fracture malunion. This group represented 29% of patients (24 of 82) who underwent a limb lengthening procedure for a similar diagnosis during the review period. At each postoperative visit, the accuracy and precision of distraction, bone alignment, joint ROM, and any complications were recorded by the senior surgeon (SRR). Accuracy reflected how close the measured lengthening was to the prescribed distraction at each postoperative visit, while precision reflected how close the repeated measurements were to each other over the course of total lengthening period. No patients were lost to followup. Minimum followup from surgery was 3 weeks (mean, 14 weeks; range, 3-29 weeks). RESULTS: Mean total lengthening was 35 mm (range, 14-65 mm), with an accuracy of 96% and precision of 86%. All patients achieved target lengthening with minimal unintentional effects on bone alignment. The knee and ankle ROM were minimally affected. Of the complications requiring return to the operating room for an additional surgical procedure, there was one (4%) implant failure caused by a nonfunctional distraction mechanism and six (24%) non-implant-related complications, including premature consolidation in one patient (4%), delayed bone healing in two (8%), delayed equinus contracture in two (8%), and toe clawing in one (4%). CONCLUSIONS: We conclude that this internal lengthening nail is a valid option to achieve accurate and precise limb lengthening to treat a variety of conditions with limb shortening or length discrepancy. Randomized, larger-sample, long-term studies are required to further confirm clinical efficacy of these devices, monitor for any late failures and complications, and compare with other internal lengthening devices with different mechanisms of operation. LEVEL OF EVIDENCE: Level IV, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

Mechanical characteristics of a novel posterior-step prosthesis for biconcave glenoid defects.

BACKGROUND: Posterior glenoid defects increase the risk of glenoid component loosening after total shoulder arthroplasty (TSA). The goal of this work was to evaluate the mechanical performance of a novel posterior-step glenoid prosthesis, designed to compensate for biconcave (type B2) glenoid defects. Two prototypes ("Poly-step" and "Ti-step") were constructed by attaching polyethylene or titanium step-blocks onto standard (STD) glenoid prostheses. We hypothesized that the mechanical performance of the experimental prostheses in the presence of a B2 defect would be similar to that of an STD prosthesis in the absence of a defect. METHODS: Fifteen normal shoulder specimens were consistently loaded under simulated muscle activity while peri-glenoid bone strains were measured. In 5 specimens, arthroplasty was performed with an STD glenoid prosthesis. In the remaining 10 specimens, a 20° B2 glenoid defect was created before arthroplasty was performed with the Poly-step or Ti-step prosthesis. RESULTS: Load-induced peri-glenoid strains after TSA with either the STD or Poly-step prosthesis did not show statistical differences as compared with the native joints (P > .05). A posterior defect decreased superior glenoid strain as compared with the intact specimens (P < .05). The change in strains after Poly-step prosthesis implantation in the presence of a biconcave glenoid defect was not different than the change induced by STD prosthesis implantation in the absence of a defect. In contrast, strains after Ti-step prosthesis implantation were statistically different from those induced by the STD and Poly-step prostheses (P < .05). CONCLUSIONS: The Poly-step prosthesis may be a viable option for treating posterior glenoid defects.