Comparison of the Results of Complex Ankle Fractures Treated With and Without Ankle Arthroscopy

Ankle Fractures Clinical Trial

Official title:

Operative Treatment of Complex Ankle Fractures: Comparison of the Results With and Without Ankle Arthroscopy-a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02449096
• Other study ID #: 117-15
• Status: Recruiting
• Phase: N/A
• First received: April 7, 2015
• Last updated: October 18, 2015
• Start date: July 2015
• Est. completion date: June 2025

Study information

• Verified date: October 2015
• Source: Ludwig-Maximilians - University of Munich
• Contact: Mareen Braunstein, M.D.
• Phone: 0049-89-440052511
• Email: Mareen.Braunstein[@]med.uni-muenchen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2025
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

Device:
• Arthroscope
AORIF - arthroscopically assisted open reduction and internal fixation of acute ankle fractures

Other:
• No arthroscope
ORIF - open reduction and internal fixation of acute ankle fractures

Locations

Country	Name	City	State
Germany	Ludwig Maximilians University, LMU, Munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Loren GJ, Ferkel RD. Arthroscopic assessment of occult intra-articular injury in acute ankle fractures. Arthroscopy. 2002 Apr;18(4):412-21. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AOFAS (American Orthopedic Foot and Ankle Society) Score		24 months (1-10 year follow-up anticipated)	Yes
Secondary	JSSF Score (Japanese Society of Surgery of the Foot)		24 months (1-10 year follow-up anticipated)	Yes
Secondary	Olerud and Molander Score		24 months	Yes
Secondary	Karlsson Score		24 months	Yes
Secondary	Tegner Activity Scale		24 months	Yes
Secondary	SF-12 Questionnaire		24 months	Yes
Secondary	Radiographic analysis		24 months	Yes
Secondary	Arthroscopic findings of intraarticular lesions		24 months	Yes
Secondary	Time to return to work/sports		24 months	Yes