NCT07814638

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

September 7, 2026

Last Update Submit

September 7, 2026

Conditions

Ankle FracturesUnstabel Ankle Fractures

Keywords

Ankle fractureImmediate protected weight bearingRehabilitationWalker bootRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Olerud-Molander Ankle Score (OMAS).

    6 weeks, 12 weeks, 6 months and 12 months after surgery

Secondary Outcomes (2)

  • Visual Analogic Scale (VAS) for pain

    6 weeks, 12 weeks, 6 months and 12 months.

  • SF-12 quality of life

    6 weeks, 12 weeks, 6 months and 12 months.

Study Arms (2)

Immediate protected weight bearing

EXPERIMENTAL

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

Other: Immediate protected weight bearingOther: Rehabilitation

Conventional treatment

ACTIVE COMPARATOR

Conventional non-weight bearing for 6 weeks followed by progressive weight bearing plus standardized rehabilitation

Other: Rehabilitation

Interventions

Immediate protected weight bearingOTHER

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

Immediate protected weight bearing
RehabilitationOTHER

Standardised rehabilitation after surgery

Conventional treatmentImmediate protected weight bearing

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sant Joan Despí Moisès Broggi - Consorci Sanitari Integral

Sant Joan Despí, Barcelona, 08970, Spain

Location

MeSH Terms

Conditions

Ankle Fractures

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2026

First Posted

September 11, 2026

Study Start

January 15, 2023

Primary Completion

January 15, 2025

Study Completion

January 15, 2026

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)