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

NCT02449096 | Unknown DMC

• 1 other identifier: 117-15
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (1)

• AOFAS (American Orthopedic Foot and Ankle Society) Score

  24 months (1-10 year follow-up anticipated)

Secondary Outcomes (8)

• JSSF Score (Japanese Society of Surgery of the Foot)

  24 months (1-10 year follow-up anticipated)

• Olerud and Molander Score

  24 months

• Karlsson Score

  24 months

• Tegner Activity Scale

  24 months

• SF-12 Questionnaire

  24 months

Study Arms (2)

ORIF group

OTHER

No arthroscope ORIF = Open reduction and internal fixation All Patients will be operated following a standardized protocol of our foot and ankle department: Posterior malleolus: ORIF of the posterior malleolus fractures will be performed using a one-third tubular plate in an antiglide-technique. Lateral malleolus: If the patients suffer a fracture of the posterior and lateral malleolus, a posterolateral approach will be performed. After posterior fracture fixation a lag screw and a one-third tubular plate will be used laterally. In special cases a locking plate will be used. If the patient only suffers a lateral malleolus fracture, we utilize the standard lateral incision. Medial malleolus: We perform a curved incision and two cannulated leg screws/tension wiring or locking plate for fixation. Syndesmotic complex: After all, the stability of the syndesmotic complex is tested and reduction will be performed if necessary.

Other: No arthroscope

AORIF group

ACTIVE COMPARATOR

Arthroscope AORIF = Arthroscopically assisted open reduction and internal fixation Our standard operative protocol is described above. Intervention: In case of randomization to the AORIF group, the arthroscopic procedure will be performed as the first step during the surgery before internal fixation. No distraction device will be used for the ankle. To avoid lesions of the cartilage and soft tissue, the joint will first be inflated with saline, and the portals will be created by blunt dissection. A 2.7mm, 30° arthroscope will be inserted into the ankle through a standard anteromedial portal. Fluid will be aspirated and the cavity filled with water. Afterwards the standard anterolateral portal will be performed in the same way. A standardized systematic examination as described by Ferkel and Fasulo will be performed to inspect the internal structures. At this stage loose bodies and disrupted ligaments extending into the joint will be removed.

Device: Arthroscope

Interventions

Arthroscope DEVICE

AORIF - arthroscopically assisted open reduction and internal fixation of acute ankle fractures

AORIF group

No arthroscope OTHER

ORIF - open reduction and internal fixation of acute ankle fractures

ORIF group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Ludwig Maximilians University, LMU, Munich

Munich, Bavaria, 80336, Germany

RECRUITING

Related Publications (13)

• 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. doi: 10.1016/s1067-2516(00)80070-8.

  PMID: 11131471 BACKGROUND

• 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. doi: 10.5435/00124635-201104000-00007.

  PMID: 21464216 BACKGROUND

• Hintermann B, Regazzoni P, Lampert C, Stutz G, Gachter A. Arthroscopic findings in acute fractures of the ankle. J Bone Joint Surg Br. 2000 Apr;82(3):345-51. doi: 10.1302/0301-620x.82b3.10064.

  PMID: 10813167 BACKGROUND

• Aktas S, Kocaoglu B, Gereli A, Nalbantodlu U, Guven 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.

  PMID: 18348824 BACKGROUND

• Loren GJ, Ferkel RD. Arthroscopic assessment of occult intra-articular injury in acute ankle fractures. Arthroscopy. 2002 Apr;18(4):412-21. doi: 10.1053/jars.2002.32317.

  PMID: 11951201 BACKGROUND

• 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. doi: 10.1016/j.arthro.2003.10.019.

  PMID: 14673447 BACKGROUND

• 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. doi: 10.1053/jars.2003.50111.

  PMID: 12724683 BACKGROUND

• 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. doi: 10.1016/j.arthro.2004.04.070.

  PMID: 15241315 BACKGROUND

• 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.

  PMID: 19962076 BACKGROUND

• 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. doi: 10.1177/107110070102200207.

  PMID: 11249221 BACKGROUND

• 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. doi: 10.1097/01.ta.0000114062.42369.88.

  PMID: 15625464 BACKGROUND

• 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.

  PMID: 19181977 BACKGROUND

• Braunstein M, Baumbach SF, Regauer M, Bocker W, Polzer H. The value of arthroscopy in the treatment of complex ankle fractures - a protocol of a randomised controlled trial. BMC Musculoskelet Disord. 2016 May 12;17:210. doi: 10.1186/s12891-016-1063-2.

  PMID: 27175917 DERIVED

MeSH Terms

Conditions

Ankle Fractures

Interventions

Arthroscopes

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Officials

• Hans Polzer, M.D.

  Munich University Clinic, Ludwig-Maximilians-University, Department of Trauma Surgery, Foot and Ankle Surgery, LMU, Munich

  STUDY DIRECTOR

Central Study Contacts

Mareen Braunstein, M.D.

CONTACT

0049-89-440052511; Mareen.Braunstein@med.uni-muenchen.de

Hans Polzer, M.D.

CONTACT

0049-89-440052511; Hans.Polzer@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Mareen Braunstein, M.D.

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: May 20, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2025
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

DE (1)