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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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) g

Detailed Summary:

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 (AORI
Sponsor: Ludwig-Maximilians - University of Munich

Current Primary Outcome: AOFAS (American Orthopedic Foot and Ankle Society) Score [ Time Frame: 24 months (1-10 year follow-up anticipated) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • JSSF Score (Japanese Society of Surgery of the Foot) [ Time Frame: 24 months (1-10 year follow-up anticipated) ]
  • Olerud and Molander Score [ Time Frame: 24 months ]
  • Karlsson Score [ Time Frame: 24 months ]
  • Tegner Activity Scale [ Time Frame: 24 months ]
  • SF-12 Questionnaire [ Time Frame: 24 months ]
  • Radiographic analysis [ Time Frame: 24 months ]
  • Arthroscopic findings of intraarticular lesions [ Time Frame: 24 months ]
  • Time to return to work/sports [ Time Frame: 24 months ]


Original Secondary Outcome: Same as current

Information By: Ludwig-Maximilians - University of Munich

Dates:
Date Received: April 7, 2015
Date Started: July 2015
Date Completion: June 2025
Last Updated: October 18, 2015
Last Verified: October 2015