Clinical Trial: Is Deltoid Ligament Repair for Ankle Fracture Necessary?

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Is Deltoid Ligament Repair in Supination-external Rotation Ankle Fractures Necessary? A Prospective Cohort Study.

Brief Summary: The investigator hypothesizes that primary acute ankle deltoid ligament repair can help restore ankle radiographic congruity and functional outcomes.

Detailed Summary: The purpose of this study is to evaluate whether stabilization with anatomic ankle deltoid ligament repair can help restore ankle congruity and improve functional outcome in patients with unstable supination-external rotation ankle fractures.
Sponsor: Mayo Clinic

Current Primary Outcome: Change in Functional Improvement as measured by the Short Musculoskeletal Function Assessment (SMFA) [ Time Frame: baseline, 6 month post-operative visit ]

The 46-item SMFA questionnaire comprises two parts: the dysfunction index with 34 items and the bother index with 12 items. Each item has a 5-point response format (1 point for good function or not bothered and 5 points for poor function or extremely bothered).

The scores of the dysfunction and the bother indices are calculated by summing up the responses to the items and then transforming the scores according to the formula: (actual raw score - lowest possible raw score)/(possible range of raw score) × 100. This transformation formula gives the final scores, which ranged from 0 to 100. The higher scores indicate poorer function.



Original Primary Outcome: Same as current

Current Secondary Outcome: Mean Score on American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Scale [ Time Frame: 2 year postoperative visit ]

The AOFAS Hindfoot Scale is an outcome rating system for ankle replacements. It is composed of the parameters pain (max 40 points), function (max 50 points) and alignment (max 10 points). Scores can range from 0 (severe pain, severely impaired function, and poor alignment) to 100 (no pain, no limitations on function, good alignment.)


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: May 19, 2016
Date Started: May 2016
Date Completion: May 2018
Last Updated: August 8, 2016
Last Verified: August 2016