A Noninferiority RCT Comparing Operative vs Nonoperative Treatment for ER-stress Positive Weber-B Unimalleolar Fractures

NCT01758796 | Unknown DMC

• 1 other identifier: OYSrct-Ankle3.2
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Current gold standard treatment for unstable (those found unstable in external rotation (ER) stress testing Weber B-type, Lauge-Hansen supination-external rotation type IV) ankle fractures is open reduction and internal fixation (ORIF) with semitubular plates and screws. However, there is some preliminary evidence to suggest that these type of fibula fractures can be managed non-operatively with comparable functional outcome. The aim of this randomized, non-inferiority trial is to assess whether non-operative treatment (cast immobilisation) yields a non-inferior functional outcome compared to surgery with no excess harms (primarily, fracture and wound healing problems and infection).

Conditions

Lateral Malleolus Fracture

Keywords

ER-stress positive; Unimalleolar fibula fracture; Operative vs non-operative treatment

Outcome Measures

Primary Outcomes (1)

• Olerud-Molander Outcome Score (OMAS)

  OMAS; scale from 0 to 100, higher scores indicating better outcomes and fewer symptoms. validated, condition-specific, patient-reported measure of ankle fracture symptoms.

  2 years

Secondary Outcomes (5)

• The Foot and Ankle Outcome Score (FAOS)

  2 years

• RAND 36 Health Item Survey (RAND-36)

  2 years

• a 100 mm Visual Analogue Scale for function and pain (VAS)

  2 years

• Fracture healing

  2 years

• Ankle joint movement

  2 years

Other Outcomes (1)

• Talocrural joint congruence

  At two, six and 12 weeks, and at 2 years

Study Arms (2)

Non-operative

EXPERIMENTAL

Non-operative treatment with six weeks in a below-the-knee cast. Partial weight-bearing (15 to 20 kilograms) for the first four weeks and then weight-bearing as tolerated for the remaining two weeks.

Procedure: Non-operative treatment

Surgery

ACTIVE COMPARATOR

Open reduction and internal fixation with 1/3 semitubular plate and screws. Post-operatively, surgically treated ankles are placed in a below-the-knee cast for six weeks. They are advised to carry out partial weight-bearing (15 to 20 kilograms) for the first four weeks and then weight-bear as tolerated for the remaining two weeks.

Procedure: Surgery

Interventions

Non-operative treatment PROCEDURE

Below-the-knee cast for six weeks.

Non-operative

Surgery PROCEDURE

Open reduction and internal fixation with 1/3 semi-tubular plate and screws.

Surgery

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Weber B unimalleolar ankle fracture
• Age: 16 years or older
• Voluntary
• Operated within 7 days of the trauma
• Walking without aid before accident

You may not qualify if:

• Peripheral neuropathy
• Pilon fracture
• Bilateral ankle fracture
• Simultaneous crural fracture
• Pathological fracture
• Active infection around the ankle
• A previous ankle fracture or significant medial ligament trauma
• Lives outside our hospital district or a foreigner
• Co-operation is insufficient

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

OYS, Oulu university hospital, Department of orthopedic and traumatology

Oulu, North Ostrobothnia, 90100, Finland

Location

Related Publications (1)

• Kortekangas T, Lehtola R, Leskela HV, Taimela S, Ohtonen P, Savola O, Jarvinen TLN, Pakarinen H. Cast immobilisation versus surgery for unstable lateral malleolus fractures (SUPER-FIN): randomised non-inferiority clinical trial. BMJ. 2026 Jan 14;392:e085295. doi: 10.1136/bmj-2025-085295.

  PMID: 41534905 DERIVED

MeSH Terms

Conditions

Ankle Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Harri J Pakarinen, MD, PhD

  Oulu University Hospital

  STUDY DIRECTOR

• Tero HJ Kortekangas, MD, PhD

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Interpretation of data is blinded to treatment group allocation. More precisely, the interpretation of data is carried out without knowledge of the actual treatment given to the particular group, rather labelling groups as "Group 1" and "Group 2". Only then the randomization code is broken, correct data interpretation is chosen, and the draft of the manuscript is finalised.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic surgeon, MD, PhD

Study Record Dates

• First Submitted: December 26, 2012
• First Posted: January 1, 2013
• Study Start: January 1, 2013
• Primary Completion: July 7, 2021
• Study Completion: April 1, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)