Alessio Bernasconi1,2, Paolino Iorio3, Yaser Ghani4, Miltiadis Argyropoulos4, Shelain Patel4, Alexej Barg5,6, Francesco Smeraglia3, Giovanni Balato3, Matthew Welck4. 1. Department of Public Health, Trauma and Orthopaedics, University of Naples Federico II, Naples, Italy. alebernas@gmail.com. 2. Foot and Ankle Unit, Royal National Orthopaedic Hospital, Stanmore, UK. alebernas@gmail.com. 3. Department of Public Health, Trauma and Orthopaedics, University of Naples Federico II, Naples, Italy. 4. Foot and Ankle Unit, Royal National Orthopaedic Hospital, Stanmore, UK. 5. Department of Orthopaedics, Trauma and Reconstructive Surgery, University Medical Center Hamburg-Eppendorf, Hamburg , Germany. 6. Department of Orthopaedics, University of Utah, Salt Lake City, UT, USA.
Abstract
INTRODUCTION: Intramedullary locking devices (ILDs) have recently been advocated as a minimally invasive approach to manage displaced intraarticular calcaneal fractures (DIACFs), to minimise complications and improve outcomes. We reviewed clinical and biomechanical studies dealing with commercially available devices to identify their characteristics, efficacy and safety. METHODS: Following a PRISMA checklist, Medline, Scopus and EMBASE databases were searched to identify studies reporting the use of ILDs for treating DIACFs. Biomechanical studies were first evaluated. Cohort studies were then reviewed for demographics, surgical technique, postoperative protocol, clinical and radiographic scores, complications and reoperations. The modified Coleman Methodology Score (CMS) was used to assess the quality of studies. RESULTS: Eleven studies were identified which investigated two devices (Calcanail®, C-Nail®). Three biomechanical studies proved they offered adequate primary stability, stiffness, interfragmentary motion and load to failure. Eight clinical studies (321 feet, 308 patients) demonstrated a positive clinical and radiographic outcome at 16-months average follow-up. Metalware irritation (up to 20%) and temporary nerve entrapment symptoms (up to 30%) were the most common complications, while soft tissue issues (wound necrosis, delayed healing, infection) were reported in 3-5% of cases. Conversion to subtalar fusion was necessary in up to 6% of cases. Four (50%) out of 8 studies were authored by implant designers and in 5 (62%) relevant conflicts of interest were disclosed. Mean (± standard deviation) CMS was 59 ± 9.8, indicating moderate quality. CONCLUSIONS: Treating DIAFCs with ILDs leads to satisfactory clinical outcomes at short-term follow-up, enabling restoration of calcaneal height and improved subtalar joint congruency. Metalware irritation and temporary nerve entrapment symptoms are common complications although wound complications are less frequent than after open lateral approaches. The quality of evidence provided so far is moderate and potentially biased by the conflict of interest, raising concerns about the generalisability of results. LEVEL OF EVIDENCE: Level V - Review of Level III to V studies.
INTRODUCTION: Intramedullary locking devices (ILDs) have recently been advocated as a minimally invasive approach to manage displaced intraarticular calcaneal fractures (DIACFs), to minimise complications and improve outcomes. We reviewed clinical and biomechanical studies dealing with commercially available devices to identify their characteristics, efficacy and safety. METHODS: Following a PRISMA checklist, Medline, Scopus and EMBASE databases were searched to identify studies reporting the use of ILDs for treating DIACFs. Biomechanical studies were first evaluated. Cohort studies were then reviewed for demographics, surgical technique, postoperative protocol, clinical and radiographic scores, complications and reoperations. The modified Coleman Methodology Score (CMS) was used to assess the quality of studies. RESULTS: Eleven studies were identified which investigated two devices (Calcanail®, C-Nail®). Three biomechanical studies proved they offered adequate primary stability, stiffness, interfragmentary motion and load to failure. Eight clinical studies (321 feet, 308 patients) demonstrated a positive clinical and radiographic outcome at 16-months average follow-up. Metalware irritation (up to 20%) and temporary nerve entrapment symptoms (up to 30%) were the most common complications, while soft tissue issues (wound necrosis, delayed healing, infection) were reported in 3-5% of cases. Conversion to subtalar fusion was necessary in up to 6% of cases. Four (50%) out of 8 studies were authored by implant designers and in 5 (62%) relevant conflicts of interest were disclosed. Mean (± standard deviation) CMS was 59 ± 9.8, indicating moderate quality. CONCLUSIONS: Treating DIAFCs with ILDs leads to satisfactory clinical outcomes at short-term follow-up, enabling restoration of calcaneal height and improved subtalar joint congruency. Metalware irritation and temporary nerve entrapment symptoms are common complications although wound complications are less frequent than after open lateral approaches. The quality of evidence provided so far is moderate and potentially biased by the conflict of interest, raising concerns about the generalisability of results. LEVEL OF EVIDENCE: Level V - Review of Level III to V studies.