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NCT Number: NCT06023979

Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.

The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.

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Key information

Conditions

Post Operative Treatment After Unstable Malleolar Fractures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This study aims to compare the postoperative results after PWB (partial weight bearing) and early FWB (full weight bearing) and to show, that documented early protected weight-bearing after surgical fixation of unstable ankle fractures leads to an improved early clinical outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB is safe in terms of complication rate.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients with surgically stabilized unstable ankle fractures
  • signed informed consent
  • closed tibial and fibular epiphysis
  • age 18 or older

Exclusion criteria

  • dementia and other known cognitive impairment or incapacity of judgement
  • polytrauma
  • bilateral injury of the lower extremities
  • additional injury of the ipsilateral lower extremity which prevents full weight bearing
  • associated injury of one or both upper extremities
  • open fractures grade II° and III°
  • chronic loss of sensation on plantar aspect of the feet due to known distal neuropathy
  • open epiphysis
  • pregnancy

Treatment and study plan

Full weight bearing

Other

Full weight bearing monitored with a bio-feedback insole

Partial weight bearing

Other

Partial weight bearing monitored with a bio-feedback insole

Primary outcomes

  1. Manchester Oxford Foot and Ankle Questionnaire

    Time frame: 1 year

    Patient reported Outcome measure

Secondary outcomes

  1. other PROMs (patient reported outcome measures)

    Time frame: 1 year

  2. Range of Motion

    Time frame: 1 year

  3. Secondary dislocation of fracture

    Time frame: 6 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Primoz Potocnik, MD

CONTACT

[email protected]

0041714941111

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles. A Single Blinded Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 5, 2023
Registry last updated
Sep 5, 2023

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.