Is Deltoid Ligament Repair for Ankle Fracture Necessary?

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02863042

Acronym

AnkleFX

Enrollment

Registered

2016-08-11

Start date

2016-05-31

Completion date

2018-08-20

Last updated

2018-08-22

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

Conditions

Ankle Fracture

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.

Interventions

PROCEDURERepair Deltoid Tendon

OTHERAnkle Fracture Without Deltoid Tendon Repair

Standard of care

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026