A Prospective Randomized Pilot Study to Compare Open Versus Percutaneous Syndesmosis Repair of Unstable Ankle Fractures

NCT02245893 | Unknown

• 1 other identifier: 103747
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates fracture healing, anatomic reduction and return to functioning in patients with unstable Weber C type fractures of the ankle. Best outcomes are obtained when a good alignment of the ankle joint is maintained and natural function of the syndesmosis (space between the tibia and fibula bones) is restored. The syndesmosis and ankle joint is stabilized by a series of ligaments which are often damaged in Weber C type fractures. Current syndesmosis repair techniques traverse the tibia and fibula, but do not anatomically reconstruct the ligaments. The investigators will compare reconstruction of the unstable syndesmosis by open reduction and internal fixation using a syndesmosis screw coupled with anterior ligament (AiTFL) anatomic repair technique (ART) to percutaneous repair using a syndemosis screw only (SCREW). Radiographic, pain and functional outcome scores will be compared between the groups using validated outcome measures.

Conditions

Fracture Dislocation of Ankle Joint

Outcome Measures

Primary Outcomes (1)

• CT scan

  assessment of ankle alignment

  3 month

Secondary Outcomes (6)

• Foot and Ankle Outcome Score (FAO),

  6 weeks, 3 , 6 , 12 months

• AOFAS Hindfoot Score

  6 weeks, 3 , 6 , 12 months

• Maryland Foot Score

  6 weeks, 3 , 6 , 12 months

• Radiographic healing

  6 weeks, 3 , 6 , 12 months

• Complication- Infection

  6 weeks, 3 , 6 , 12 months

Study Arms (2)

Screw

ACTIVE COMPARATOR

In the SCREW Group (standard surgery technique), surgical treatment will be by closed reduction utilizing intraoperative fluoroscopy to visualize the reduction and percutaneous syndesmosis screw insertion. Intraoperative fluoroscopic stress and non-stress views will be obtained as per standard of care. 'open reduction internal fixation (ORIF)

Procedure: open reduction internal fixation (ORIF)

Anatomic repair technique (ART)

ACTIVE COMPARATOR

In the ART group (study group) surgical treatment will be by open reduction and internal fixation. In order to stabilize the syndesmosis, direct visual anatomic alignment will be conducted and a syndesmotic screw inserted. In addition, fixation of the anterior ligament will be performed with use of a 2.7 to 4.0 mm suture anchor. Repair of the intact portion of the ligament will be made using a modified Mason -Allen repair. Intraoperative fluoroscopic stress and non-stress views will be obtained as per standard of care. 'open reduction internal fixation (ORIF)

Procedure: open reduction internal fixation (ORIF)

Interventions

open reduction internal fixation (ORIF) PROCEDURE

The study design is a prospective, randomized pilot clinical trial of the treatment of unstable syndesmosis injuries sustained with Weber C type fractures. Comparison will be made between two syndesmosis stabilization methods: 1) Percutaneous (closed) reduction using syndesmosis fixation by SCREW 2) Open reduction (ORIF) with ART repair of the anterior ligament and stabilization of the syndesmosis by use of a syndesmosis screw.

Anatomic repair technique (ART); Screw

Eligibility Criteria

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

You may qualify if:

• The subject is 18 years old or greater with a pre-operative diagnosis of a Weber C ankle fracture (supination-external rotation, pronation-external rotation, pronation-abduction patterns).
• The subject demonstrates lateral subluxation of the talus on x-ray or stress views (unstability).
• The lateral malleolus fracture if present begins at least 1.0 cm proximal to the syndesmosis.
• The subject has no history of previous ankle injury.
• The subject does not have an ipsilateral lower extremity injury that would impede results.
• The subject has no neuromuscular or neurosensory deficiency that would limit the ability to assess the operative procedure.

You may not qualify if:

• The subject has a lateral malleolus fracture that begins less than 1.0 cm proximal to the syndesmosis.
• The subject has an open ankle fracture with a lateral wound. -

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A4G5, Canada

Location

Related Publications (22)

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  PMID: 3881447 BACKGROUND

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  BACKGROUND

• Forsythe K, Freedman KB, Stover MD, Patwardhan AG. Comparison of a novel FiberWire-button construct versus metallic screw fixation in a syndesmotic injury model. Foot Ankle Int. 2008 Jan;29(1):49-54. doi: 10.3113/FAI.2008.0049.

  PMID: 18275736 BACKGROUND

• Soin SP, Knight TA, Dinah AF, Mears SC, Swierstra BA, Belkoff SM. Suture-button versus screw fixation in a syndesmosis rupture model: a biomechanical comparison. Foot Ankle Int. 2009 Apr;30(4):346-52. doi: 10.3113/FAI.2009.0346.

  PMID: 19356360 BACKGROUND

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• Klitzman R, Zhao H, Zhang LQ, Strohmeyer G, Vora A. Suture-button versus screw fixation of the syndesmosis: a biomechanical analysis. Foot Ankle Int. 2010 Jan;31(1):69-75. doi: 10.3113/FAI.2010.0069.

  PMID: 20067726 BACKGROUND

• Miller RS, Weinhold PS, Dahners LE. Comparison of tricortical screw fixation versus a modified suture construct for fixation of ankle syndesmosis injury: a biomechanical study. J Orthop Trauma. 1999 Jan;13(1):39-42. doi: 10.1097/00005131-199901000-00009.

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• Ogilvie-Harris DJ, Reed SC, Hedman TP. Disruption of the ankle syndesmosis: biomechanical study of the ligamentous restraints. Arthroscopy. 1994 Oct;10(5):558-60. doi: 10.1016/s0749-8063(05)80014-3.

  PMID: 7999167 BACKGROUND

• Miller AN, Carroll EA, Parker RJ, Boraiah S, Helfet DL, Lorich DG. Direct visualization for syndesmotic stabilization of ankle fractures. Foot Ankle Int. 2009 May;30(5):419-26. doi: 10.3113/FAI-2009-0419.

  PMID: 19439142 BACKGROUND

• Pelton K, Thordarson DB, Barnwell J. Open versus closed treatment of the fibula in Maissoneuve injuries. Foot Ankle Int. 2010 Jul;31(7):604-8. doi: 10.3113/FAI.2010.0604.

  PMID: 20663427 BACKGROUND

• Miller AN, Carroll EA, Parker RJ, Helfet DL, Lorich DG. Posterior malleolar stabilization of syndesmotic injuries is equivalent to screw fixation. Clin Orthop Relat Res. 2010 Apr;468(4):1129-35. doi: 10.1007/s11999-009-1111-4. Epub 2009 Oct 2.

  PMID: 19798540 BACKGROUND

Study Officials

• David Sanders

  Western Univeristy/Lawson Health ResearcH Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 22, 2014
• Study Start: August 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: June 1, 2020
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)