A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Ankle Injuries |
Device: Antiglide Plate Device: Lateral Plate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ankle Fracture Plating: A Multicenter Randomized Trial Comparing Lateral and Antiglide Plating in Displaced Lateral Malleolus Fractures |
- Functional Scores: SF12v2, SMFA, AOFAS ankle/hindfoot scale [ Time Frame: Preoperative (or initial hospitalization), 6, 12, 26, and 52 week standard of care visits ] [ Designated as safety issue: No ]
- Comparison of functional scores in a priori subgroup: >60 vs <60 years old. [ Time Frame: Discharge 6, 9, and 12 months post-operation ] [ Designated as safety issue: No ]
- Comparison in functional scores in a priori subgroup: Good bone quality vs poor bone quality [ Time Frame: discharge 6, 9, and 12 months post-operation ] [ Designated as safety issue: No ]
- Comparison of functional scores in a priori subgroup: Those with syndesmotic injury versus those without. [ Time Frame: discharge 6, 9, and 12 months post-operation ] [ Designated as safety issue: No ]
| Enrollment: | 249 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Randomized
Randomized treatment
|
Device: Antiglide Plate
A plate is placed behind the broken ankle and secured with screws
Other Name: Antiglide Plate
Device: Lateral Plate
A metal plate is placed to the side of the broken ankle and is secured with screws
Other Name: Lateral Plate
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| Orthopaedic Associates of Michigan | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Minnesota | |
| Hennepin County Medical Center | |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, Missouri | |
| Barnes-Jewish Hospital | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| New York Hospital for Joint Diseases | |
| New York, New York, United States, 10003 | |
| United States, Ohio | |
| Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| University of Oklahoma/ Health Science | |
| Oklahoma City, Oklahoma, United States, 73190 | |
| United States, Texas | |
| Orthopaedic Specialty Associates Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| Canada | |
| Dalhousie University | |
| Halifax, Nova Scotia, Canada | |
| Principal Investigator: | Paul Tornetta, MD | Boston University / Boston Medical Center |
| Principal Investigator: | Laura Phieffer, MD | Ohio State University |
More Information
No publications provided
| Responsible Party: | Paul Tornetta, III, M.D., Principal Investigator, Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT00718302 History of Changes |
| Other Study ID Numbers: | H-27190 |
| Study First Received: | July 16, 2008 |
| Last Updated: | March 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Boston Medical Center:
|
Ankle Fractures Displaced Lateral Malleolus Fractures Antiglide Plating Lateral Plating |
Additional relevant MeSH terms:
|
Fractures, Bone Ankle Injuries Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 21, 2013