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

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06023979

Enrollment

110

Registered

2023-09-05

Start date

2023-09-01

Completion date

2026-10-31

Last updated

2023-09-05

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

Conditions

Post Operative Treatment After Unstable Malleolar Fractures

Keywords

malleolar fractures, postoperative treatment protocol, full weight bearing, partial weight bearing, bio-feedback insoles

Brief summary

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.

Detailed description

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.

Interventions

OTHERFull weight bearing

Full weight bearing monitored with a bio-feedback insole

OTHERPartial weight bearing

Partial weight bearing monitored with a bio-feedback insole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Manchester Oxford Foot and Ankle Questionnaire	1 year	Patient reported Outcome measure

Secondary

Measure	Time frame
other PROMs (patient reported outcome measures)	1 year
Range of Motion	1 year
Secondary dislocation of fracture	6 weeks

Countries

Switzerland

Contacts

Primary ContactPrimoz Potocnik, MD

primoz.potocnik@kssg.ch0041714941111

Outcome results

None listed

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