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NCT Number: NCT07814638

Immediate Protected Weight Bearing Versus Conventional Non-Weight Bearing After Surgical Fixation of Unstable Ankle Fractures

This prospective randomized controlled trial evaluates the safety and effectiveness of immediate protected weight bearing following surgical fixation of unstable ankle fractures. Participants are randomized to immediate protected weight bearing from the first postoperative day using a Walker boot and crutches or conventional non-weight bearing for six weeks. Functional outcome (OMAS), pain (VAS), ankle range of motion, quality of life (SF-12), and postoperative complications are assessed over 12 months.

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Key information

Conditions

Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Unstabel Ankle Fractures Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan Despí Moisès Broggi - Consorci Sanitari Integral

Sant Joan Despí, Barcelona, 08970, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unstable ankle fracture requiring ORIF.
  • Written informed consent.

Exclusion criteria

  • Psychiatric disorder.
  • Pre-existing mobility limitation.
  • Cognitive impairment.
  • BMI >30 kg/m².
  • Poorly controlled type 2 diabetes.
  • Soft tissue injury requiring external fixation.
  • Gustilo II/III open fractures.
  • Unstable fixation.
  • Refusal/inability to consent or allow anonymized data use.
  • Any condition compromising safety or validity.

Treatment and study plan

Immediate protected weight bearing

Other

Immediate protected weight bearing from postoperative day 1 using a Walker boot and crutches

rehabilitation

Other

Standardised rehabilitation after surgery

Primary outcomes

  1. Olerud-Molander Ankle Score (OMAS).

    Time frame: 6 weeks, 12 weeks, 6 months and 12 months after surgery

Secondary outcomes

  1. Visual Analogic Scale (VAS) for pain

    Time frame: 6 weeks, 12 weeks, 6 months and 12 months.

  2. SF-12 quality of life

    Time frame: 6 weeks, 12 weeks, 6 months and 12 months.

Sponsors and collaborators

Lead sponsor

Consorci Sanitari Integral

Other

Registry information

Official study title

Immediate Protected Weight Bearing Versus Conventional Non-Weight Bearing After Surgical Fixation of Unstable Ankle Fractures: A Prospective Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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