Health TrialsbyHealthPanel

Syndesmotic Screw Vs Suture Button in Ankle Syndesmotic Diastasis

ConditionsSyndesmotic ScrewSuture ButtonFixationAnkle Syndesmotic Diastasis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTanta University

About this trial

The aim of this study is to compare suture-button versus syndesmotic screw in the treatment of distal tibiofibular syndesmotic injury.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age : 18 - 60 years old.

Closed or grade I open fractures are included.

Isolated syndesmotic injury.

associated lateral malleolus fracture with talar shift.

Disqualifiers

Skeletal immaturity.

Previous ipsilateral ankle surgery.

Non-ambulatory status before injury.

Inability to comply with postoperative protocol (i.e., advanced dementia).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Suture button fixation

    Procedure/Surgery

    Patients undergoing suture button fixation of syndesmosis injury.

  • Syndesmotic screw fixation

    Procedure/Surgery

    Patients undergoing syndesmotic screw fixation of syndesmosis injury.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Suture button fixationExperimental treatment 1 intervention
Group B: Syndesmotic screw fixationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The American Orthopaedic Foot and Ankle Society (AOFAS)

As an interpretation of the American Orthopaedic Foot and Ankle Society (AOFAS) score, excellent results with score between (95-100). Good results between (75-94). Fair results between (51-74). Poor results between (0-50).

Time frame
12 months postoperatively

Secondary outcomes

1

Degree of pain

Degree of pain was assessed using an interpretation of visual analogue scale (VAS) score, No pain with score 0, mild pain with score between (1-3), moderate pain with score between (4-7) and severe pain with score between (8-10). VAS was assessed at 6 weeks, 6 months and 12 months postoperatively.

Time frame
12 months postoperatively
2

Ankle Range of motion (ROM)

Motion of the ankle occurs primarily in the sagittal plane, with plantar- and dorsiflexion occurring predominantly at the tibiotalar joint. Overall Ankle range of motion (ROM) in the sagittal plane of between 65 and 75°, moving from 10 to 20° of dorsiflexion through to 40-55° of plantarflexion. Sagittal motion (flexion plus extension) Normal or mild restriction (30° or more) : 8 Moderate restriction (15°-29°) : 4 Severe restriction (less than 15°) : 0

Time frame
12 months Postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: