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Clinical Trials/NCT02245893
NCT02245893UnknownNot Applicable

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

Lawson Health Research Institute2 sites in 1 country50 target enrollmentStarted: August 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
2
Primary Endpoint
CT scan

Study Overview

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.

Detailed Description

High ankle fractures involve fracture of the fibula above the level of the syndesmosis (space between the tibia and fibula bones) that result from indirect mechanisms (e.g. pronation-external rotation (twisting) injuries. The method of injury is assumed to disrupt one or more of the syndesmotic ligaments, leading to instability of the ankle mortise . High ankle fractures comprise a significant proportion of ankle injuries (16 to 45 % of all ankle fractures patterns) . It is generally agreed that operative intervention of ankle injuries is indicated in cases of instability . However, recent advances in the understanding of the biomechanics of the ankle have given rise to particular areas of clinical uncertainty, including the treatment of unstable syndesmotic injuries and reliability of strictly radiographic assessment of ankle fractures .

The goal of operative treatment is to anatomically reduce the ankle mortise to permit syndesmosis ligament healing and restoration of the normal tibiofibular joint dynamics. Even 1 mm of displacement or lateral shift of the talus will affect ankle joint loading and lead to dysfunction and potentially degenerative joint changes. Accurate reduction of the syndesmosis and maintenance of this reduced position until the ligaments heal is crucial to ensure good outcome and to avoid long term arthritic changes in the tibiofibular joint .

If the ankle joint is unstable (too much sideways movement), the syndesmosis space between the two bones in the ankle (tibia and fibula) needs to be stabilized. One method to treat unstable syndesmosis injuries is making an incision to expose the ankle to provide direct visualization of fracture for anatomic reduction (alignment) and insertion of one or two syndesmosis screws to maintain the relationship of the fibula to the tibia. This is referred to as open reduction and internal fixation (ORIF).

Another method of repair is by closed reduction of the ankle joint and the use of one or two percutaneous syndesmosis screws only. That is, syndesmosis stabilization can be done percutaneously using intraoperative fluoroscopy to visualize the repair . Literature and standard practice support both of these methods.

The syndesmosis joint complex is composed of the anterior inferior tibiofibular ligament (AiTFL), the posterior inferior tibiofibular ligament (PiTFL) and the interosseous membrane (IOM). This complex is believed to permit ankle mortise stability and flexibility due to the elasticity of the ligaments, which allows the intermalleolar distance to change and facilitates tibial and fibular rotation. It also maintains the axis of balanced loading of the foot through the fibula. Adequate stability and anatomic restoration of the syndesmosis joint complex is vital to restoring normal tibiotalar contact forces in order to lessen the risk of posttraumatic arthritis.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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. -

Arms & Interventions

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)

Intervention: open reduction internal fixation (ORIF) (Procedure)

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)

Intervention: open reduction internal fixation (ORIF) (Procedure)

Outcomes

Primary Outcomes

CT scan

Time Frame: 3 month

assessment of ankle alignment

Secondary Outcomes

  • 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)
  • Complication-Implant Failure(6 weeks, 3 , 6 , 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David Sanders

Orthopedic Surgeon

Lawson Health Research Institute

Study Sites (2)

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