A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.

NCT04429217 | Recruiting

• 1 other identifier: ORL-ORT-012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will compare two types of rehabilitation in patients who undergo a surgery for treatment of malleolar fractures: immediate complete weight-bearing and delayed weight-bearing. The investigators want to evaluate if the immediate complete weight-bearing can improve and hasten the functional outcome of the ankle without increasing the risk of complications.

Conditions

Lateral Malleolus Fracture

Keywords

Ankle; surgical treatment; malleolar fractures

Outcome Measures

Primary Outcomes (1)

• change from day 1 after surgery in subjective functional ankle recovery on the Olerud-Molander Ankle Score at week 6

  Functional ankle recovery is measured using the Olerud-Molander Ankle Score (OMAS)- The OMAS is a validated, self-administered patient questionnaire designed to subjectively evaluate ankle function after fracture. The scale is an ordinal functional rating scale based on nine different items given different points. The total score is calculated as the sum of each rated item and range from 0 points (totally impaired function) to 100 points (completely unimpaired function). The OMAS questionnaire will be administered after surgery (visit 1, day 1) and at week 6 (visit 3). A negative change from the day of surgery to week 6 will indicate an improvement in OMAS score and, therefore, in functional ankle recovery.

  baseline and week 6

Secondary Outcomes (12)

• change in subjective functional ankle recovery on the Olerud-Molander Ankle Score during the first 24 weeks after surgery

  baseline, week2, week 12 and week 24

• Change form day of surgery in functional ankle disability on the Foot and Ankle Disability Index (FADI) during the first 24 weeks after surgery

  baseline, 2, 6, 12 and 24 weeks

• Change form baseline in pain on the Numerical Rating Scale (NRS)

  baseline, 12 and 24 weeks

• Daily pain and function

  12 weeks

• change in quality of life on the 36-Item Short Form Health Survey (SF-36 questionnaire).

  baseline, 2, 6,12 and 24 weeks

Other Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events as Assessed by the Clavien-Dindo classification.

  from surgery up to 48 weeks

Study Arms (2)

Arm-A

EXPERIMENTAL

experimental post-operative rehabilitation intervention consisting in immediate weight-bearing

Other: immediate post-operative complete weight-bearing after surgery

Arm-B

ACTIVE COMPARATOR

control post-operative rehabilitation intervention consisting in delayed weight-bearing

Other: delayed weight-bearing for 6 weeks after surgery

Interventions

immediate post-operative complete weight-bearing after surgery OTHER

Patients randomized to the experimental post-operative rehabilitation intervention will undergo to immediate complete weight-bearing starting immediately after surgery. Immediate complete weight-bearing consists in the possibility to undergo all the everyday activities without limiting weight-bearing and without the use of walking aids. During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED); this will ensure the safety of the early recovery phases, protecting from dangerous movements while allowing the mobilization in the healthy range of movement.

Arm-A

delayed weight-bearing for 6 weeks after surgery OTHER

Patients randomized to the control post-operative rehabilitation intervention will undergo to delayed weight-bearing starting at 6-weeks post-operatively. Delayed weight-bearing consists in the limitation of the weight-bearing to 20-30% of patient's total weight using crutches for the first 6 weeks after surgery. During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED).

Arm-B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults
• Age ranging from 18 to 70 years, included
• Signed Informed Consent
• Ankle fracture requiring surgical management classified as:1- Weber A fracture pattern (AO 44.A1, 44.A2, 44.A3) with or without association with a medial or posterior lesion/fracture or 2- Weber B fracture pattern (AO 44.B1, 44.B2, 44.B3) with or without association with a medial or posterior lesion/fracture
• Willingness and ability to participate in the trial

You may not qualify if:

• Weber C fracture pattern
• Bilateral fractures or fractures in other locations
• Maissoneauve associated lesion
• Body Mass Index \< 18.5 and ≥ 30
• Metabolic diseases influencing fracture healing processes
• Medical comorbidities precluding operative intervention
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.
• Inability or contraindications to undergo the investigated intervention
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Pregnant women

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

Ente Ospedaliero Cantonale

Lugano, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Ankle Fractures

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Enrique Adrian Testa, MD

  EOC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrique Adrian Testa, MD

CONTACT

+41 (0)91 811 69 31; enriqueadrian.testa@eoc.ch

Christian Candrian, MD, Prof

CONTACT

+41 091 811 61 23; Christian.candrian@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: clinical assessments will be assessed by an investigator blinded with respect to the rehabilitation regimen and all outcomes will be analysed by a statistician blinded to the moment when they were registered / administered (baseline or time points after randomization).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: April 28, 2020
• Primary Completion (Estimated): February 2, 2028
• Study Completion (Estimated): February 2, 2028
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)