A Prospective, Randomized Investigation of Syndesmosis Injury Fixation

Study ID
STU 072012-022

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
LaTasha Stevenson
214-648-4323
latasha.stevenson@utsouthwestern.edu

Principal Investigator
Ashoke Sathy

Summary

This study will compare the FDa approved Tightrope syndesmosis injury fixation system to the traditional metal screw fixation of an operative syndesmosis ankle injury. The investigators will also compare the surgical, clinical and radiographic outcomes of the Tightrope procedure to the screw fixation.

Study Design: This is a one- year multi-center, prosepctive study

Research Plan:
any patient seen by the Pi or co-investigator following acute, traumatic injury to the ankle that is found to be a candidate for syndesmosis metal screw fixation will be asked to participate in the study provided they meet the inclusion criteria listed in the protocol.

The subject will then be enrolled in the study and randomly assorted in to two groups using a pre-selected, randomization process. The randomization will be performed via an envelope that is opened in the operating room before the operative procedure.

The patient will either receive the standard of care metal screw fixation or the Tightrope procedure. The patient will be assessed for 1 year via ankle questionnaires for the post-operative evaluation and standard of care x-rays. 1 bilateral CT scan will be performed at 6 weeks for research purposes.

The primary endpoint for this study will be bi-lateral ankle radiographic comparison and subsequent analysis of the tibia/fibia overlap on the aP standing x-rays at 52 weeks.

Secondary analsis will include the data comparison from the post-operative questionnaires acroos the two groups (screw fixation and tightrope procedure)

Participant Eligibility

Inclusion Criteria: All patients must meet the following:

* Age 18 x 65 years

* Complete history and physical examination

* An isolated acute ankle syndesmosis injury with or without ankle fracture which requires operative treatment. (this may be determined intra-operatively)

* Clinical and radiographic confirmation of an acute ankle syndesmosis injury.

* An understanding of the purpose of the study and have signed the informed consent.