Comparison of the Results of Complex Ankle Fractures Treated With and Without Ankle Arthroscopy
Information source: Ludwig-Maximilians - University of Munich
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankle Fractures
Intervention: Arthroscope (Device); No arthroscope (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Ludwig-Maximilians - University of Munich Official(s) and/or principal investigator(s): Hans Polzer, M.D., Study Director, Affiliation: Munich University Clinic, Ludwig-Maximilians-University, Department of Trauma Surgery, Foot and Ankle Surgery, LMU, Munich
Overall contact: Mareen Braunstein, M.D., Phone: 0049-89-440052511, Email: Mareen.Braunstein@med.uni-muenchen.de
Summary
Background: An anatomical reconstruction of ankle congruity is an important prerequisite in
the operative treatment of acute ankle fractures. But, despite an anatomic reduction,
patients suffer from residual problems like chronic pain, stiffness, persistent swelling and
instability after these fractures. There is growing evidence, that this poor outcome is
related to the concomitant traumatic intraarticular pathology. Therefore, supplementary
ankle arthroscopy has been proposed in acute ankle fractures as it is a valuable tool to
confirm the anatomic reposition and to further identify and manage associated intraarticular
injuries. The arthroscopic treatment of these pathologies might result in a better outcome
after complex ankle fractures. Nevertheless, until now, the vast majority of ankle fractures
are managed by open procedures only. Still, indications for arthroscopically assisted open
reduction and internal fixation (AORIF) are not clearly stated, and the effectiveness of
AORIF compared with open reduction and internal fixation (ORIF) has not yet been determined
for complex ankle fractures. In this context, only a prospective randomized study can
sufficiently answer these open questions. Therefore, the investigators plan a randomized
controlled trial intended to report the short-, midterm- and long-term follow-up of patients
who underwent operative treatment of acute ankle fractures - with and without ankle
arthroscopy.
Methods/Study design: The investigators will perform a randomized controlled trial
evaluating the effect of AORIF compared to ORIF with a sample size of 40 patients per group.
The investigators include patients with an acute ankle fracture after written informed
consent. Primary outcome of the investigators' study is the difference of the AOFAS score
(American Orthopedic Foot and Ankle Society) between the intervention (AORIF) and comparison
(ORIF) group after a follow-up of 2 years. Several secondary outcome parameters will be
assessed as well. Statistical analysis will be performed using a two-sided Student`s t-test.
Discussion: Until today, there are only two randomized controlled trials evaluating the
effect of open reduction and internal fixation (ORIF) compared to arthroscopically assisted
open reduction and internal fixation (AORIF). Both studies only included patients with
isolated fractures of the distal fibula at the level of the syndesmosis. These are the most
simple fractures that are regularly treated operatively. Both studies documented a high
incidence of intraarticular disorders in the AORIF group, but only one could show
significant better results in the AORIF group. Moreover, several other studies could
consistently demonstrate that the intraarticular damage is even more pronounced the more
complex the fracture is. Consequently, a more distinctive effect of arthroscopy in complex
fractures involving two malleoli or more has to be assumed when compared to these simple
fractures.
Clinical Details
Official title: Operative Treatment of Complex Ankle Fractures: Comparison of the Results With and Without Ankle Arthroscopy-a Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AOFAS (American Orthopedic Foot and Ankle Society) Score
Secondary outcome: JSSF Score (Japanese Society of Surgery of the Foot)Olerud and Molander Score Karlsson Score Tegner Activity Scale SF-12 Questionnaire Radiographic analysis Arthroscopic findings of intraarticular lesions Time to return to work/sports
Detailed description:
Acute ankle fractures are one of the leading pathologies disturbing ankle congruence. These
fractures are extremely common with an incidence of 0. 1-0. 2% per year. The treatment of
acute ankle fractures is determined by the classification of the injury based on
radiographic findings. Operative treatment performing open reduction and internal fixation
(ORIF) is the standard of care for unstable or dislocated ankle fractures. Anatomical
realignment of the joint and restoration of ankle stability are the main goals of the
operative treatment. Over the last decades the improved functional outcome has emphasized
the importance of anatomic reconstruction. Nevertheless, successful anatomical reduction
does not automatically lead to favorable clinical outcome. According to several studies, the
mid- and long-term outcome following operative treatment of acute ankle fractures is often
poor even though anatomical reconstruction of the joint has been achieved. Residual problems
after acute ankle fractures include chronic pain, stiffness, recurrent swelling and
instability. These problems occur despite the operative restoration of ankle congruence.
There is growing evidence that the poor outcome might be mostly related to occult articular
injuries involving cartilage and soft tissue damage. These intraarticular disorders have
been shown to negatively affect the clinical results, but it is difficult to diagnose these
intraarticular pathologies by physical examination, standard radiography or even CT-scans.
In this context, many authors have well documented the value of ankle arthroscopy. Ankle
arthroscopy is a standard minimally invasive technique that allows direct visualization of
intraarticular structures without arthrotomy or malleolar osteotomy. In the last decades, it
has become a safe and effective diagnostic and therapeutic procedure. In acute ankle
fractures, arthroscopically assisted open reduction and internal fixation (AORIF) allows
careful examination of the chondral aspects as well as the capsular and intraarticular
ligaments. If necessary, the traumatic intraarticular pathologies can directly be addressed
by removing loose bodies and ruptured ligaments extending into the joint, performing
chondroplasty or micro fracturing if necessary. Furthermore, it allows a confirmation of the
anatomic reduction without having any evidence that a supplementary ankle arthroscopy in
acute ankle fracture treatment leads to a higher complication rate.
Until today, there are only two randomized controlled trials evaluating the effect of
additional ankle arthroscopy. Both studies available comparing ORIF to AORIF included only
patients with isolated fractures of the distal fibula at the level of the syndesmosis only.
These are the most simple fractures that are regularly treated operatively. Thodarson et al.
compared ORIF treatment of distal fibula fractures supplemented with or without ankle
arthroscopy and found that 8 of 9 patients had articular damage to the talar dome in the
arthroscopy group. Only minimal arthroscopic treatment was required and no outcome
differences were noted after a mean follow-up of 21 months. Takao et al. documented an
osteochondral lesion (OCL) in 74% in the arthroscopic group. In their study, the mean AOFAS
score was significantly better when patients were treated arthroscopically. Moreover,
several studies could consistently document, that the intraarticular damage is more
pronounced the more complex the fracture is. Consequently, one must assume a more
distinctive effect of arthroscopy in more complex fractures involving two malleoli or more -
when compared to simple fractures.
Nevertheless, until now, the vast majority of ankle fractures are managed by open procedures
only. Still, indications for AORIF are not clearly stated, and the effectiveness of AORIF
compared with ORIF has not yet been determined for complex ankle fractures where the
investigators would expect even better results as intraarticular lesions are more common in
these fracture types. Moreover, the prognostic importance of traumatic articular lesions
still remains unclear, although several studies suggest such injuries may be the source of
functional deficits. Nevertheless, this concept seems to be intuitively comprehensible. In
this context, only a prospective randomized study can sufficiently answer these open
questions. Therefore, the investigators plan a randomized controlled trial intended to
report the short-, midterm- and long-term follow-up of patients who underwent operative
treatment of acute ankle fractures (AO A2, A3, B2, B3, C1-C3) - with and without ankle
arthroscopy.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 18 -65 years
- Acute ankle fracture (0-14 days) classified as AO type 44 A2, A3, B2, B3, C1-C3
- Written informed consent (patient is able to read and understand German language
properly)
Exclusion Criteria:
- Patients under 18 years or over 65 years
- Patients who have acute infections, mental illnesses, high anesthesiological risk
(ASA >3)
- Patients with expected incompliance
- Pregnant women, prisoners or patients under guardianship
- Acute ankle fracture classified as AO type 44 A1 or B1 fracture, pilon or
plafond-variant injury
- Open fractures
- Fractures with radiologically detectable intraarticular lesions
- Patients without written informed consent
Men and women aged 18-65 years with an acute ankle fracture (AO 44 A2, A3, B2, B3, C1, C2,
C3) according to the judgment of the surgeons of the foot and ankle team of our level I
trauma center are enrolled in the trial. Each fracture will be evaluated and graded
according to classification reported by AO Foundation (figure 1). Patients will be
informed about our current investigation by detailed patient information. Only patients,
who confirm the operative procedure, will be enrolled. To avoid misclassification, all
radiographs will be evaluated by at least two of the three orthopedic surgeons.
Disagreements will be resolved by consent. Only patients with a maximum interval of two
weeks between injury and intervention must be included. All patients included must be able
to understand the meaning of the trial and its consequences. Written informed consent is
mandatory for trial inclusion. No additional investigation (clinical or radiographic
investigation) will take place if the patient is included compared to patients who refuse
inclusion. A list of inclusion and exclusion criteria can be found below. Patients will be
excluded in case of open fractures or radiographically identified intraarticular lesions.
Also, patients with a high risk of anesthesiology problems (i. e., ASA risk score > 3),
acute infection, mental illness or low expected compliance will be excluded from trial
participation. If patients issue a certain treatment preference, they will be excluded as
well. Patients, who meet our inclusion criteria or any exclusion criteria, will be
informed in detail. After written informed consent, patients will be randomized to one of
the two study arms.
Locations and Contacts
Mareen Braunstein, M.D., Phone: 0049-89-440052511, Email: Mareen.Braunstein@med.uni-muenchen.de Additional Information
Related publications: Sorrento DL, Mlodzienski A. Incidence of lateral talar dome lesions in SER IV ankle fractures. J Foot Ankle Surg. 2000 Nov-Dec;39(6):354-8. Bonasia DE, Rossi R, Saltzman CL, Amendola A. The role of arthroscopy in the management of fractures about the ankle. J Am Acad Orthop Surg. 2011 Apr;19(4):226-35. Review. Hintermann B, Regazzoni P, Lampert C, Stutz G, Gächter A. Arthroscopic findings in acute fractures of the ankle. J Bone Joint Surg Br. 2000 Apr;82(3):345-51. Aktas S, Kocaoglu B, Gereli A, Nalbantodlu U, Güven O. Incidence of chondral lesions of talar dome in ankle fracture types. Foot Ankle Int. 2008 Mar;29(3):287-92. doi: 10.3113/FAI.2008.0287. Loren GJ, Ferkel RD. Arthroscopic assessment of occult intra-articular injury in acute ankle fractures. Arthroscopy. 2002 Apr;18(4):412-21. Takao M, Ochi M, Uchio Y, Naito K, Kono T, Oae K. Osteochondral lesions of the talar dome associated with trauma. Arthroscopy. 2003 Dec;19(10):1061-7. Takao M, Ochi M, Naito K, Uchio Y, Kono T, Oae K. Arthroscopic drilling for chondral, subchondral, and combined chondral-subchondral lesions of the talar dome. Arthroscopy. 2003 May-Jun;19(5):524-30. Review. Ono A, Nishikawa S, Nagao A, Irie T, Sasaki M, Kouno T. Arthroscopically assisted treatment of ankle fractures: arthroscopic findings and surgical outcomes. Arthroscopy. 2004 Jul;20(6):627-31. Glazebrook MA, Ganapathy V, Bridge MA, Stone JW, Allard JP. Evidence-based indications for ankle arthroscopy. Arthroscopy. 2009 Dec;25(12):1478-90. doi: 10.1016/j.arthro.2009.05.001. Review. Thordarson DB, Bains R, Shepherd LE. The role of ankle arthroscopy on the surgical management of ankle fractures. Foot Ankle Int. 2001 Feb;22(2):123-5. Takao M, Uchio Y, Naito K, Fukazawa I, Kakimaru T, Ochi M. Diagnosis and treatment of combined intra-articular disorders in acute distal fibular fractures. J Trauma. 2004 Dec;57(6):1303-7. Leontaritis N, Hinojosa L, Panchbhavi VK. Arthroscopically detected intra-articular lesions associated with acute ankle fractures. J Bone Joint Surg Am. 2009 Feb;91(2):333-9. doi: 10.2106/JBJS.H.00584.
Starting date: June 2015
Last updated: May 19, 2015
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