Surgical Versus Functional Treatment for Acute Ruptures of the Lateral Ligament Complex of the Ankle in Young Males - A Randomized Controlled Trial With a Mean of 14 Years Follow-up

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00954330

Enrollment

Registered

2009-08-07

Start date

1991-02-28

Completion date

2008-12-31

Last updated

2009-08-07

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

Conditions

Ankle Injury

Keywords

rct, intervention, surgery, lateral ligament injury of the ankle, REturn to pre-injury level

Brief summary

The aim of this prospective randomized controlled trial was to compare the effectiveness of surgical and conservative treatment in acute lateral ligament injury of ankle. The more detailed aims were to assess the function, physical activity level, re-injuries, objective stability and radiographic changes seen by magnetic resonance imaging in patients randomized to surgery or to functional treatment after a mean of 14 years follow-up.

Interventions

PROCEDURElateral ligament surgery

. The disrupted FTA or/and FC and superficial retinacular structures were repaired by using absorbable sutures. In case of avulsion from the bone, the ligament was reapproximated with the use of sutures that were passed through 2.0 millimeter drill-holes in the bone.

DEVICEfunctional treatment

Twenty-six patients randomized to the functional treatment received a functional light-weight orthotic device (Air-Cast ankle brace, Summit, New Jersey) for 3 weeks. Full weight bearing was allowed. The ankle brace allowed dorsi- and plantarflexion but it restricted inversion and eversion of the ankle.

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

19 Years to 25 Years

Inclusion criteria

* The inclusion criteria included positive stress radiographs (in all cases) and arthrography 15 (5 cases) proven fibulotalar anterior (FTA) and fibulocalcanear (FC) ligament injury. * The positive findings for a lateral ligament injury included a clinically unstable ankle and a radiological talar tilt \>6 degrees or ADS \>5 mm compared with the uninjured opposite ankle.

Exclusion criteria

* The

Design outcomes

Primary

Measure	Time frame
The main outcome measure in the present study was a validated ankle injury scoring scale, A Performance Test Protocol and Scoring Scale for the Evaluation of Ankle Injuries.	—

Secondary

Measure	Time frame
Return to pre-injury level in physical activity, re-injuries of the same ankle, visits to physician due to the same ankle, range of joint motion, subjective satisfaction and complications were measured	—

Countries

Finland

Outcome results

None listed

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