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Ankle Plating

1.  IMPRESS

Steering Committee

2.  SOLVED

3.  rhBMP-2

4.  Femur Outcomes

5.  Damage Control

6.  Sacral Fractures

8. Scapula Fractures

Title

Antiglide versus Lateral Plating: A Multicenter Randomized Trial

Summary

The role of operative fixation of unstable, displaced lateral malleolus fractures is well-established (1-3). However, the optimal type of fixation remains the subject of debate. Lag screw fixation alone is only appropriate for long oblique fractures in younger patients (4). For all other patients, the choices for fibular stabilization most commonly involve the use of plates and screws which can be placed on either the lateral or posterior side of the bone, with or without lag screws. Lateral plating remains the most popular option, but since the description of posterior plating in 1982, reports in the literature have demonstrated some advantages of posterior over lateral plating (5-10). These advantages include less dissection, less palpable hardware, and decreased likelihood of intra-articular screw placement. However, there is only a single retrospective study in the published literature directly comparing these two methods (11). The purpose of this randomized, prospective, multicenter study was is to assess clinical, radiographic and functional results in a cohort of patients who sustained a rotationally unstable ankle and were treated surgically with one of these two constructs.

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Research Design

We have chosen the patient as the unit of randomization. Therefore, single patients with closed unstable supination eversion type Weber B fibula fractures will be randomized to one treatment alternative only. Randomization should lead to approximately the same number of patients in the two groups. All participants will be assigned individual study numbers in a consecutive order through a password protected, web-based, randomization system. Once logged in, the PI or designee will fill out the inclusion/exclusion form electronically. If the patient is eligible, treatment allocation is revealed. Patient identifying information will be kept confidential following HIPAA guidelines.

We register all patients who meet the inclusion criteria and document reasons for failure to randomize. An independent Central Adjudication Committee (CAC), blinded to allocation, will review the initial radiographs and eligibility forms from all randomized patients to ensure that they met eligibility criteria. Patients will only be ruled ineligible if the grounds for ineligibility were known at the time of randomization. The CAC will include the Study Biostatistician, the Principal Investigator, and two orthopaedic surgeons

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Outcomes

Primary Analysis:

We will summarize mean functional scores with means and standard deviations. We will calculate a mean difference in functional at final follow up across both treatment groups with an independent t-test. The test will be two sided and our threshold for statistical significance will be p<0.05. Standardized mean differences (immediate post op to final follow up) across both interventions will also be compared.

Secondary Analyses:

We will employ repeated measures analysis of variance looking at time, treatment, and the interaction between the two to compare the change in functional status in both the posterolateral vs lateral plating groups at discharge  6, 9, and 12 months post-operatively.

Functional scores will be compared across apriori subgroups ( <60 vs 60 or greater years, good vs poor bone quality, and syndemostic injury or not). These secondary analyses will be deemed hypothesis-generating. We will adjust our level of statistical significance for multiple subgroup analyses (p=0.01).

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Inclusion Criteria

1. Patients aged 18 – 85
2. Closed Unstable Supination Eversion type Weber B fibula fracture
3. Soft tissue amenable to operative treatment
4. Opt for surgical treatment of their fracture
5. Willing to follow up for 1 year
6. Consent to be randomized
 

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Exclusion Criteria

1. Aged < 18 or over 85
2. Open fracture
3. Prisoners
4. Unlikely to followup
5. Non english speaking
6. Pre-existing arthrosis of the ankle
7. Limitation in lower extremity function that would affect outcome scoring
8. Significant anterior comminution precluding antiglide fixation

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References

1.   Meyer TL, Jr., Kumler KW. A.S.I.F. technique and ankle fractures. Clin Orthop Relat Res (150):211-6, 1980.

2.   Mak KH, Chan KM, Leung PC. Ankle fracture treated with the AO principle--an experience with 116 cases. Injury 16(4):265-72, 1985.

3.   Yablon IG, Heller FG, Shouse L. The key role of the lateral malleolus in displaced fractures of the ankle. J Bone Joint Surg Am 59(2):169-73, 1977.

4.   Tornetta P, 3rd, Creevy W. Lag screw only fixation of the lateral malleolus. J Orthop Trauma 15(2):119-21, 2001.

5.   Brunner CF WB. The antiglide plate. In: Special Techniques in Internal Fixation. New York: Springer-Verlag, 1982:115-33.

6.   Ostrum RF. Posterior plating of displaced Weber B fibula fractures. J Orthop Trauma 10(3):199-203, 1996.

7.   Treadwell JR, Fallat LM. The antiglide plate for the Danis-Weber type-B fibular fracture: a review of 71 cases. J Foot Ankle Surg 32(6):573-9, 1993.

8.   Winkler B, Weber BG, Simpson LA. The dorsal antiglide plate in the treatment of Danis-Weber type-B fractures of the distal fibula. Clin Orthop Relat Res (259):204-9, 1990.

9.   Wissing JC, van Laarhoven CJ, van der Werken C. The posterior antiglide plate for fixation of fractures of the lateral malleolus. Injury 23(2):94-6, 1992.

10. Patel MM AS, Yoo JU, Marcus RE, Patterson BM, Vallier HA. Lateral neutralization versus posterior antiglide plating of closed distal fibula fractures:  Results and outcomes. 2003 Orthopaedic Trauma Association Annual Meeting. Salt Lake City, UT, 2003.

11. Lamontagne J, Blachut PA, Broekhuyse HM et al. Surgical treatment of a displaced lateral malleolus fracture: the antiglide technique versus lateral plate fixation. J Orthop Trauma 16(7):498-502, 2002.

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