Is Deltoid Ligament Repair for Ankle Fracture Necessary?

Not Applicable

Withdrawn

• Conditions: Ankle Fracture
• Interventions: Other: Ankle Fracture Without Deltoid Tendon Repair; Procedure: Repair Deltoid Tendon

• Registration Number: NCT02863042
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Status Verified: 2018-08
• Primary Completion: 2018-08-20
• Study Completion: 2018-08-20
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ankle Fracture Without Deltoid Tendon Repair	Ankle Fracture Without Deltoid Tendon Repair	-
Deltoid Tendon Repaired	Repair Deltoid Tendon	Repair Deltoid Tendon

Primary Outcome Measures

Name	Time	Method
Change in Functional Improvement as measured by the Short Musculoskeletal Function Assessment (SMFA)	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.

Secondary Outcome Measures

Name	Time	Method
Mean Score on American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Scale	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.)

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States