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

Cantonal Hospital of St. Gallen

Status: Not yet enrolling

Conditions: Post Operative Treatment After Unstable Malleolar Fractures

Treatments: Other: Partial weight bearing; Other: Full weight bearing

Study type: Interventional

Funder types: Other

Identifiers

NCT06023979

BASEC Nr. 2023-01242

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Full weight bearing

Experimental group

Description:

After 2 weeks after surgery the arm will begin full weight bearing

Treatment:

Other: Full weight bearing

Partial weight bearing

Active Comparator group

Description:

The arm will perform partial weight bearing for 6 weeks after surgery

Treatment:

Other: Partial weight bearing