Ankle Fracture Plating: A Multicenter Randomized Trial Comparing Lateral and Antiglide Plating in Displaced Lateral Malleolus Fractures
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Ankle Injuries
- 发起方
- Boston Medical Center
- 入组人数
- 249
- 试验地点
- 10
- 主要终点
- Percentage of Nonpalpable Hardware
- 状态
- 已完成
- 最后更新
- 9年前
概览
简要总结
The role of operative fixation of unstable, displaced lateral malleolus fractures is well-established (Mayer, Mak, and Yablon). 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 (Tornetta). 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 (Brunner), reports in the literature have demonstrated some advantages of posterior over lateral plating (Ostrum, Treadwell, Winkler, and Wissing) . 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 (Lamontagne).
详细描述
Since it was first described in 1982, posterior antiglide plating has been presented as an attractive alternative to lateral plating of distal fibula fractures. Biomechanical studies have shown it to be a stronger construct than lateral plating, and other purported advantages include less dissection, decreased potential for intra-articular screw placement, and less palpable hardware decreasing the need for hardware removal.However, although posterior plating has become an accepted technique for operative management of these injuries, there is little clinical information in the literature regarding this treatment, and only one published retrospective study directly comparing posterior to lateral plating. In 1996, Ostrum published a prospective study evaluating posterior plating in 32 patients, but only compared his results to a cohort of patients treated with lateral plating that was not part of his actual study group.Patel et al. recently presented a retrospective comparison of both techniques, but their study only included 29 patients in the lateral plating group and 23 in the posterior group.In both these studies, posterior plating was felt to be superior to lateral plating based on both the decrease in complications/re-operations related to symptomatic hardware, and improved function and pain scores. However, in a much larger study, Lamontagneet al. showed no differences in operative time, complications or hardware removal rates in 193 patients reviewed retrospectively, and concluded that they could not recommend one treatment method over the other. They even elected not to proceed with a planned prospective study based on their results.A recent retrospective analysis of 70 patients showed a 43% incidence of need for hardware removal due to pain, with 30% of these patients having peroneal tendon lesions identified intra-operatively.
研究者
Paul Tornetta, III, M.D.
Principal Investigator
Boston Medical Center
入排标准
入选标准
- •Patients aged 18 - 85
- •Closed Unstable Supination Eversion type Weber B fibula fracture
- •Soft tissue amenable to operative treatment
- •Opt for surgical treatment of their fracture
- •Willing to follow up for 1 year
- •Consent to be randomized
排除标准
- •Aged \< 18 or over 85
- •Open fracture
- •Prisoners
- •Unlikely to followup
- •Non english speaking
- •Pre-existing arthrosis of the ankle
- •Limitation in lower extremity function that would affect outcome scoring
- •Significant anterior comminution precluding antiglide fixation
- •Bilateral Fracture
结局指标
主要结局
Percentage of Nonpalpable Hardware
时间窗: 3 months, 6 months, 12 months
Percentage of Participants with Nonpalpable Hardware
次要结局
- SMFA - Bother Index(3 months, 6 months, 12 months)
- Percentage Normal Peroneal Tendons(3 months, 6 months, 12 months)
- The Short Musculoskeletal Functional Assessment (SMFA) Score(3 months, 6 months, 9 months)
- American Orthopedic Foot and Ankle Society Score (AOFAS) Scores(3 months, 6 months, 12 months)