Distal Tibia Fractures: Locking or Non-Locking Plate? EOA Annual Meeting 2013 Miami Beach Florida Nader Toossi, MD Amrit S. Khalsa, MD Loni P. Tabb, PhD Nirav H. Amin, MD Douglas L. Cerynik, MD

We have nothing to disclose Disclosure We have nothing to disclose

Background There has been recent reports in the literature expressing concerns over increased rate of non-union and delayed union after locked plating.1 While some studies report no difference between locked and non-locked plating regarding these complications.2 Henderson et al. Locking plates for distal femur fractures: is there a problem with fracture healing? J Orthop Trauma 2011;25 Suppl 1:S8-14. Newman et al.Distal metadiaphyseal tibial fractures. Injury 2011;42-10:975-84.

Background So the controversies are still there, necessitating a new look into this issue. Systematic review of the literature may help casting light on the problem.

Hypothesis Treating distal tibia fractures by locked plating leads to less complications than non-locked plating.

Purpose To compare the outcomes of locked plating versus non-locked plating in the fixation of distal tibia fractures.

Methods and Materials Using PubMed, we identified articles up to June 2012 involving minimally invasive locked and non-locked plating of acute distal tibia fractures.

“locking plates” OR “locked plating” OR “plate fixation” “minimally invasive” OR “MIPO” OR “MILPO” Distal tibia fracture OR “Pilon fracture”

Inclusion Criteria 1) English language articles; 2) Studies with at least ten clinical cases involving patients with 18 years of age or older; 3) Open and closed fractures defined as a “distal” AO 42A-C and all AO 43A-C (based on AO classification of fractures).

Exclusion Criteria 1)Double plating application; 2) Biomechanical cadaveric or experimental studies; 3) Using a lateral approach for non-invasive plating of the distal tibia rather than a medial approach; 4) Non-specification of minimally-invasive osteosynthesis technique; 5) Non-specification of locked versus non-locked plating.

Flow Diagram of Search Process Titles identified from PubMed search (n=539) Excluded as irrelevant title (n=472) Abstracts selected for abstract review ( n=67) Excluded as not meeting inclusion criteria (n=38) Articles selected for full-text review (n=29) Excluded as not reporting enough data (n=2) Studies included in the final analysis (n=27)

Total number of fractures in the pooled data: 764 Total number of fractures treated by locked plating: 499 Total number of fractures treated by non-locked plating: 265 17 Studies 11 Studies Lau, 2008 Collinge, 2010 Ozkaya, 2009 Hazarika, 2006 Ronga, 2010 Gupta, 2010 Guo, 2010 Bahari, 2007 Ahmad, 2012 Shon, 2012 Leonard, 2009 Aksekili, 2012 Shrestha, 2011 Tong, 2012 Cheng, 2011 Ma, 2010 Salton, 2007 Borg, 2004 Oh, 2003 Helfet, 1997 Ozkaya, 2009 Pai, 2007 Krackhardt, 2005 Redfern, 2004 Maffulli, 2004 Khoury, 2002 Francois, 2004 Borens, 2009

Independent Variables

♀ ♂ Studies Characteristics (Locking Studies) Author, Year Number of cases (n) Average age (years) Number of females Length of follow-up (months) Number of intra-articular fractures Number of open fractures Locking studies Lau, 2008 48 51 24 19 18 9 Collinge, 2010 38 50 13 32 12 8 Ozkaya, 2009 22 44 25 Hazarika, 2006 20 44.7 4 Ronga, 2010 43 34 Gupta, 2010 80 36.2 16 Guo, 2010 41 44.4 17 Bahari, 2007 42 35 11 27 Ahmad, 2012 43.5 7 Shon, 2012 52 Leonard, 2009 26 31 6 28 Aksekili, 2012 14 Shrestha, 2011 2 Tong, 2012 29 48.3 Cheng, 2011 15 39.8 Ma, 2010 53 21 Salton, 2007 43.3 ♀ ♂

Major Outcomes

Studies Characteristics (Locking Studies) Author, Year Non-unions Delayed unions Superficial infections Deep infections Implant failures Re-operations Bone graft applications Wound healing difficulties Mal-alignments Implant removals Locking studies Lau, 2008 5 2 6 1 23 Collinge, 2010 Ozkaya, 2009 Hazarika, 2006 3 Ronga, 2010 Gupta, 2010 7 27 Guo, 2010 24 Bahari, 2007 4 Ahmad, 2012 Shon, 2012 Leonard, 2009 Aksekili, 2012 Shrestha, 2011 8 Tong, 2012 29 Cheng, 2011 Ma, 2010 Salton, 2007

Study-level quasibinomial regression was used on the pooled data across the included studies

Results

Average Age Distribution in Non-locked Group Number of Fractures Average Age Interval in Years

Non-locking Studies Fracture Types

Locking Studies Fracture Types

Implant removal 7% Infection 12% Malunion 2 % Delayed union 4% Incidence Implant removal 7% Infection 12% Malunion 2 % Delayed union 4% Non union 3%

Major Outcomes In Locking Plate Studies Implant removal 21 % Infection 6% Malunion 2 % Delayed union 6% Non union 2%

Table 1. Quasibinomial Regression Results for the Effect of Locking Status on Various Outcomes (i.e. Model 1) Outcome Estimate SE1 p-value2 OR3 LB4 UB6 Non-Union -0.906 0.352 0.016 0.404 0.203 0.805 Delayed Union 0.437 0.476 0.367 1.548 0.610 3.933 Bone Grafting -0.100 0.971 0.919 0.905 0.135 6.066 Superficial Infection 0.528 0.601 0.387 1.696 0.522 5.505 Deep Infection 0.023 0.575 0.968 1.023 0.332 3.156 Wound Healing Difficulty 0.811 0.842 0.345 2.249 0.432 11.716 Implant Failure -0.320 0.621 0.611 0.726 0.215 2.454 Re-operation -1.981 0.743 0.013 0.138 0.032 0.591 Malalignment -2.390 0.409 0.000 0.092 0.041 0.204 Implant Removal 1.773 0.608 0.007 5.889 1.789 19.390 1SE = Standard Error; 2Estimates with p -values < 0.05 are in bold font; 3OR = Odds Ratio; 3LB = 95% Confidence Interval Lower Bound; 5UB = 95% Confidence Interval Upper Bound.

Table 2. Quasibinomial Regression Results for the Effect of Locking Status on Various Outcomes Adjusted for All of the Independent Variables (i.e. Model 2) Outcome Estimate SE1 p-value2 OR3 LB4 UB6   Non-Union -0.824 0.600 0.185 0.439 0.135 1.421 Delayed Union 0.384 0.581 0.516 1.468 0.470 4.589 Bone Graft 1.386 1.763 0.441 4.000 0.126 126.615 Superficial Infection 0.559 0.472 0.250 1.749 0.694 4.408 Deep Infection 1.080 1.156 0.361 2.946 0.306 28.401 Wound Healing Difficulty 0.627 0.842 0.465 1.872 0.359 9.759 Implant Failure -0.031 0.601 0.959 0.969 0.299 3.147 Re-operation -2.016 0.739 0.013 0.133 0.031 0.567 Malalignment -2.287 0.727 0.005 0.102 0.024 0.422 Implant Removal 1.149 0.586 0.064 3.155 1.001 9.941 1SE = Standard Error; 2Estimates with p -values < 0.05 are in bold font; 3OR = Odds Ratio; 3LB = 95% Confidence Interval Lower Bound; 5UB = 95% Confidence Interval Upper Bound.

Limitations Lack of standardization of complications and independent variables in the studies. Comorbidities were not adjusted for either because they were not reported or underreported in the studies.

Conclusion This study demonstrated that locked plating significantly reduced the odds of reoperation and malalignment after acute distal tibia fracture treatment compared to non-locked plating. Future studies are needed to determine the cost-benefit of such devices in light of reported outcomes in this era of budget-focused health care systems.

Thank you Thank you Hahnemann University Hospital