Is Deltoid Ligament Repair for Ankle Fracture Necessary?

Ankle Fracture Clinical Trial

— AnkleFX  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02863042
• Other study ID #: 16-003179
• Status: Withdrawn
• Phase: N/A
• Start date: May 2016
• Est. completion date: August 20, 2018

Study information

• Verified date: August 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 20, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Supination-external rotation ankle fracture with deltoid ligament incompetency

• Minimum of 2 year clinical follow up

Exclusion criteria:

• Non-supination-external rotation ankle fracture

• Medial malleolus fracture

• Incomplete clinical or radiographic followup.

Related Conditions & MeSH terms

• Ankle Fracture
• Ankle Fractures
• Fractures, Bone

Intervention

Procedure:
• Repair Deltoid Tendon

Other:
• Ankle Fracture Without Deltoid Tendon Repair
Standard of care

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Functional Improvement as measured by the Short Musculoskeletal Function Assessment (SMFA)	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.	baseline, 6 month post-operative visit
Secondary	Mean Score on American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Scale	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.)	2 year postoperative visit