Treatment of Ankle Syndesmosis Injuries

A prospective, randomized study comparing the effect of TightRope (Registered Trademark) suture-button fixation versus conventional screw fixation on post-operative ankle function in patients with a Weber C ankle fracture

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000010695

Enrollment

136

Registered

2014-01-06

Start date

2014-03-01

Completion date

2015-03-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Traumatic disruption of the fibrous sheet between the tibia and fibula in the leg, frequently occurs with a broken ankle, and can result in significant mechanical dysfunction which if untreated, can lead to rapid joint degeneration. Tibio-fibular transfixation using a specially designed (syndesmotic) screw is currently the method of treatment, yet limits normal ankle motion. A new technique called the TightRope, consisting of a fine wire tired to special buttons that anchor onto the bone, offers a new way of providing better stabilization of the ankle, without requiring a second operation. This study aims to compare the accuracy and maintenance of the correct alignment of the tibia and fibula of the two techniques, and the correlation with clinical outcomes and complications. Also, the calculated total cost per injury between these two surgical methods will be analysed. This study will accrue a total of 136 participants who present to the Wellington Regional Hospital with an ankle fracture, and meet inclusion criteria. Following informed consent, participants will be randomized into either surgical intervention utilizing the TightRope procedure, or the cortical screw approach. Both groups will follow an identical post-operative management and rehabilitation programme. The effectiveness of the surgery will be x-ray assessment of the ankle joint, along with clinical outcomes utilizing the American Orthopaedics Foot and Ankle Society Score and the Foot and Ankle Disability Index Score. Range of motion, time to full weight bearing, time to return to work, and rate of complications will also be recorded. Data will then be compared between the two treatment groups. In addition, the total cost for each participant will be calculated to link clinical outcomes to cost-effectiveness.

Interventions

This study is investigating the TightRope (Registered Trademark) suture-button fixation implant device , used as an ankle diastasis fixation device. A single device will be used to surgically fixate the syndesmotic disruption associated with Weber C ankle fractures, which will take approximately 100minutes of operating time..

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Patients with a Weber C fracture less than one month old, aged between 18 – 60 years of age, with a body mass index (BMI) less than 35, and are able to provide informed consent.

Exclusion criteria

Individuals not able to give informed consent; dementia or inability to comply with instructions; those with, neuropathic arthropathy, open fractures, multi trauma, bilateral injuries, and open growth plates.

Outcome results