Open Reduction Syndesmosis Tightrope Versus Screw Fixation

NCT02199249 | Completed

• 1 other identifier: 105500
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is assumed to disrupt the syndesmotic ligaments. The goal of operative treatment is to reduce the ankle mortise to restore normal joint kinematics. Syndesmosis repair can be performed using either open or closed reduction, combined with fixation between the distal tibia and fibula. Closed fixation has demonstrated high rates of non anatomic reductions greater than 40%; therefore, open reduction will be performed in this study. Screw fixation is stable but concerns exist regarding potential excess rigidity. Recently, flexible fixation techniques combined with anatomic reduction have demonstrated improvements in functional outcomes and reduction quality. Both open reduction and flexible TightRope fixation have considerable support in the literature in cohort studies but have not been compared to open screw fixation in a randomized controlled trial. In this multi centre randomized study, radiographic, economic and functional outcomes are compared between \[open reduction, flexible Tightrope syndesmosis fixation (OT)\] and \[open reduction screw fixation (OS)\] of the syndesmosis.

Conditions

Ankle Fractures

Keywords

open anatomic reduction; syndesmosis screw fixation, syndesmosis Tightrope fixation

Outcome Measures

Primary Outcomes (1)

• anatomic reduction between the two groups using CT scan and plain radiographs.

  anatomic reduction between the two groups using CT scan and plain radiographs

  3 months

Secondary Outcomes (2)

• post-operative pain

  6 weeks, 3, 6, 12 months

• functional performance

  6 weeks, 3,6 12 months

Study Arms (2)

Open Reduction Tightrope fixation (OT)

ACTIVE COMPARATOR

Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of a single Tightrope (Arthrex-Knotless) device. Open Reduction Tightrope fixation (OT)

Device: Open reduction Tightrope fixation

Open Reduction screw fixation (OS)

ACTIVE COMPARATOR

Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of two or more syndesmosis screws. Open Reduction screw fixation (OS)

Device: open reduction screw fixation

Interventions

Open reduction Tightrope fixation DEVICE

Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of a single Tightrope (Arthrex-Knotless) device. Open Reduction Tightrope fixation (OT)

Also known as: Athrex tightrope

Open Reduction Tightrope fixation (OT)

open reduction screw fixation DEVICE

Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of two or more syndesmosis screws. Open Reduction screw fixation (OS)

Also known as: syndesmosis screw fixation

Open Reduction screw fixation (OS)

Eligibility Criteria

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

You may qualify if:

• Male or female 18yrs with a diagnosis of a closed Weber C ankle (OTA 44.C1, 44.C2, 44.C3) fracture.
• Randomization and treatment of syndesmosis injury within 14 days of the date of injury.
• Demonstrates lateral subluxation of talus on x-ray or stress views. Talar shift \> 1mm or medial clear space widening ≥ 5mm (unstable)
• No history of previous severe ankle injury, pathologic fracture, ligamentous laxity, no prior diagnosis or current treatment of osteoporosis or metabolic bone disease.
• No concurrent injury that is deemed by the treating surgeon to delay or alter the rehabilitation protocol for the ankle injury.
• No neuromuscular or sensory deficiency.
• Able to understand and complete assessments
• Provision of Informed Consent

You may not qualify if:

• Age \< 18 years
• Open fracture or pathological fracture.
• Talar shift \< 1mm or medial clear space widening \< 5mm (stable)
• Prior diagnosis or current treatment for osteoporosis or metabolic bone disease.
• Concurrent injury that is deemed by the treating surgeon to delay or alter the rehabilitation protocol for the ankle injury.
• Prior diagnosis or treatment for neuromuscular disease or sensory deficiency (i.e. diabetic neuropathy).
• Likely problems, in the judgment of the investigator, with maintaining follow-up (i.e. patients with no fixed address, patients incapable of providing informed consent, prisoners etc.).
• Patients who are currently pregnant or planning to become pregnant during the study duration.

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A4G5, Canada

Location

Related Publications (1)

• Wong MT, Wiens C, LaMothe J, Edwards WB, Schneider PS. In Vivo Syndesmotic Motion After Rigid and Flexible Fixation Using 4-Dimensional Computerized Tomography. J Orthop Trauma. 2022 May 1;36(5):257-264. doi: 10.1097/BOT.0000000000002267.

  PMID: 35594514 DERIVED

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• David Sanders, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 24, 2014
• Study Start: April 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02

Locations

CA (1)