Clinical trial NCT02199249: Open Reduction Syndesmosis Tightrope Versus Screw Fixation
Official title: A Prospective Randomized Multi Center Study to Compare Open Reduction, TightRope Fixation (OT) Versus Open Reduction Screw Fixation (OS) of the Tibia - Fibular Syndesmosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fractures
Keywords: open anatomic reduction
syndesmosis screw fixation, syndesmosis Tightrope fixation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
First posted: 2014-07-24
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

This study is a multi centre randomized controlled trial comparing clinical, economic and functional outcomes between open reduction, flexible Tightrope syndesmosis fixation (OT) to open reduction rigid screw fixation (OS) for syndesmotic injuries in high ankle fractures, involving the fibula 1 cm above the level of the syndesmosis (Weber C (OTA 44.C1, 44.C2, 44C3)).

We anticipate recruiting 72 patients (36 in each arm) from up to 20 clinical sites across North America. Post operative follow up will occur at 2 and 6 weeks, 3, 6, and 12 months. At each follow up, radiographic and functional outcomes will be assessed as well as documentation of costs associated with treatment and rehabilitation.

The research questions that this study will answer include the following:

1. Does open reduction and repair with TightRope syndesmosis fixation (OT) provide better reduction compared to open reduction and syndesmosis screw fixation (OS)?
2. Which surgical technique provides better functional outcomes?
3. Are complications and costs associated with repair comparable between surgical techniques?

The null hypothesis is that there will be no difference between the treatment groups in terms of reduction and functional testing.

The scientific aims of this study are to compare:

1. anatomic (open) reduction between the two groups using CT scan and plain radiographs.
2. post-operative pain and functional performance in each group.
3. rates of complications and costs for each method of fixation.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria

1. Age \< 18 years
2. Open fracture or pathological fracture.
3. Talar shift \< 1mm or medial clear space widening \< 5mm (stable)
4. Prior diagnosis or current treatment for osteoporosis or metabolic bone disease.
5. Concurrent injury that is deemed by the treating surgeon to delay or alter the rehabilitation protocol for the ankle injury.
6. Prior diagnosis or treatment for neuromuscular disease or sensory deficiency (i.e. diabetic neuropathy).
7. 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.).
8. Patients who are currently pregnant or planning to become pregnant during the study duration.

Primary outcomes:
measure: anatomic reduction between the two groups using CT scan and plain radiographs.
timeFrame: 3 months
Secondary outcomes:
measure: post-operative pain
timeFrame: 6 weeks, 3, 6, 12 months
measure: functional performance
timeFrame: 6 weeks, 3,6 12 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: David Sanders, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.