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A Novel, Less Invasive Approach to Distal Radius Fracture Fixation – Prospective Case Series with One Year Follow-up
Michael K. Strassmair, MD1; Daniel A. Rikli2; Jorg Schmidt, Dr, med3; Hans-Josef Erli, Dr, med4
1Klinikum Starnberg, Starnberg, Germany; 2University Hospital Basel, Basel, Switzerland; 3Klinik fur Orthopadie, Unfall-, Hand und Wiederherstellungshirurgie - Unfallklinik, Asklepios Klinik Weissenfels-Hohenmolsen GmBH, Weissenfels, Germany; 4Klinik fur Unfallchirurgie und Orthopadie, Vinvantes Humboldt-Klinikum, Berlin, Germany

Introduction: This study assesses clinical outcomes for distal radius fracture patients treated using an expandable, intramedullary fracture fixation system. Biomechanical testing of this device has previously shown axial and bending stiffness comparable to that of volar locked plates.

Methods: An international, multi-center, prospective study of patients undergoing internal fixation of a distal radius fracture using a novel, intramedullary implant was conducted. Study protocol was approved within the clinical investigators’ respective institutions and countries. Patient outcome was assessed based on DASH scores, serial radiographs, and device/procedure-related adverse event (AE) reporting. Surgical Technique – Following provisional reduction, a 2-3cm skin incision is made on the lateral aspect of the radius, proximal to the fracture site. A 5mm diameter cortical access hole is created and an implant-shaped cavity is prepared within the medullary canal. The collapsed nitinol device is introduced and allowed to expand to fill the cavity. Bone fragments are secured to the expanded implant using 2.7mm cannulated screws. Screw quantity, type and orientation can be tailored to the individual fracture pattern.

Results: A total of 60 patients (mean 67.2 years, range 20-88 years; 52 female) underwent surgery for repair of AO type A (43), B (1) and C (16) fractures, with 59 completing mean follow-up of 10.4 months (range: 3-18.2 months). The mean DASH score for all subjects who qualified for follow-up at one year or longer (n=35) was 10.3±14.3, compared with baseline and 12 week DASH scores of 70.7±20 and 22.3±17.9, respectively. Radiographic analysis confirmed the presence of bony healing in all subjects by 12 weeks and alignment in 57/59 subjects. Five post-operative AE’s were documented – four were instrument-related and/or consistent with other distal radius fracture repair techniques. The remaining, and only severe, AE was due to an associated volar-lunate facet fragment that was not secured at time of implant and subsequently displaced, necessitating revision. Removal of the implant occurred without incident. No AE’s have been reported beyond 12 weeks post-op.

Conclusions: Clinical experience with this new, less invasive technique for intramedullary management of distal radius fractures appears promising. This prospective series demonstrates the technique’s ability to treat a broad range of fracture patterns, deliver stable fixation through a tissue-preserving approach and maintain reduction throughout the healing phase. Clinically meaningful improvement in functional outcome scores were demonstrated at early and longer term follow-up. The device design specifically avoids potential flexor and extensor tendon irritation associated with other fixation techniques.

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