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

Primary Purpose

Lateral Malleolus Fracture

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Non-operative treatment
Surgery
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Malleolus Fracture focused on measuring ER-stress positive, Unimalleolar fibula fracture, Operative vs non-operative treatment

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • OYS, Oulu university hospital, Department of orthopedic and traumatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-operative

Surgery

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The Foot and Ankle Outcome Score (FAOS)
FAOS, 5 subscales from 0-100, with higher scores indicating better function
RAND 36 Health Item Survey (RAND-36)
For health-related quality-of-life. Eight subscales from 0-100, with higher scores indicating better quality of life
a 100 mm Visual Analogue Scale for function and pain (VAS)
Range from 0 to 100, with higher scores indicating more severe pain/dysfunction
Fracture healing
Fracture healing is considered complete when the fracture line disappeared and conversely, those fractures with a visible fracture line are deemed non-unions
Ankle joint movement
Research physiotherapist measures ankle dorsi- and plantarflexion using a goniometer

Full Information

First Posted
December 26, 2012
Last Updated
September 13, 2023
Sponsor
University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT01758796
Brief Title
A Noninferiority RCT Comparing Operative vs Nonoperative Treatment for ER-stress Positive Weber-B Unimalleolar Fractures
Official Title
A Prospective Randomized Non-inferiority Trial to Compare Operative Versus Non-operative Treatment for ER-stress Positive Weber-B Unimalleolar Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2013 (Actual)
Primary Completion Date
July 7, 2021 (Actual)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
Seventy per cent of ankle fractures are unimalleolar injuries, the Weber B -type of fibula fracture being by far the most common type. The ankle mortise can either be stable or unstable in this type of fracture depending on the accompanying soft tissue injury. The stability of the ankle mortise has fundamental clinical relevance, as it dictates the subsequent treatment strategy. If left untreated, an unstable ankle mortise may lead to fracture healing complications and increased risk of post-traumatic osteoarthritis and subsequently poor functional outcome. Therefore, current clinical practice guidelines recommend surgical treatment for these injuries. The gold standard surgical treatment for unstable ankle fractures is open reduction and internal fixation (ORIF) using 1/3 semi-tubular plates and screws. The most common complication following operative treatment of ankle fracture is wound infection, the incidence ranging from 6.1 to10% in unselected patient materials. To date, there is only one published randomized trial comparing operative and non-operative treatment in patients with an unstable unimalleolar fibula fracture. In this 1-year follow-up, the authors concluded that patients managed nonoperatively had equivalent functional outcomes compared with operative treatment; however, the risk of fracture displacement and problems with union was substantially higher in patients managed nonoperatively. In turn, 10/41 (24%) patients treated operatively were re-operated; five patients had a post-operative infection and five patients required hardware removal. This prospective randomized non-inferiority trial is designed to compare surgical and non-operative treatment of ER-stress positive unimalleolar ankle fractures. The primary, non-inferiority, intention-to-treat outcome is the Olerud-Molander Ankle Score at 104 weeks or 24 months (OMAS; range, 0-100; higher scores indicating better outcome and fewer symptoms). The predefined non-inferiority margin for the primary outcome at the primary assessment time point is 8 points. Secondary outcomes are ankle function, pain, quality of life, ankle range of motion, and radiographic outcome. Follow-up assessments are performed at 2, 6, 12, and 104 weeks (primary time point). Treatment related complications and harms; symptomatic non-unions, loss of congruity of the ankle joint, and wound infections are also recorded. The ER-stress test is performed by a consultant trauma orthopedic surgeon or a trauma resident who has completed trauma rotation. Medial clear space opening of 5 mm or more will be considered a positive ER stress test. Patients are randomized to non-operative or surgical treatment using a sealed envelope method. Surgical treatment is carried out using a standard 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. The non-operative treatment protocol is similar to that of the surgically treated patients: six-week below-the-knee cast with partial weight-bearing for the first four weeks and then weight-bearing as tolerated for the remaining two weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Malleolus Fracture
Keywords
ER-stress positive, Unimalleolar fibula fracture, Operative vs non-operative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-operative
Arm Type
Experimental
Arm Description
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.
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-operative treatment
Intervention Description
Below-the-knee cast for six weeks.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Open reduction and internal fixation with 1/3 semi-tubular plate and screws.
Primary Outcome Measure Information:
Title
Olerud-Molander Outcome Score (OMAS)
Description
OMAS; scale from 0 to 100, higher scores indicating better outcomes and fewer symptoms. validated, condition-specific, patient-reported measure of ankle fracture symptoms.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The Foot and Ankle Outcome Score (FAOS)
Description
FAOS, 5 subscales from 0-100, with higher scores indicating better function
Time Frame
2 years
Title
RAND 36 Health Item Survey (RAND-36)
Description
For health-related quality-of-life. Eight subscales from 0-100, with higher scores indicating better quality of life
Time Frame
2 years
Title
a 100 mm Visual Analogue Scale for function and pain (VAS)
Description
Range from 0 to 100, with higher scores indicating more severe pain/dysfunction
Time Frame
2 years
Title
Fracture healing
Description
Fracture healing is considered complete when the fracture line disappeared and conversely, those fractures with a visible fracture line are deemed non-unions
Time Frame
2 years
Title
Ankle joint movement
Description
Research physiotherapist measures ankle dorsi- and plantarflexion using a goniometer
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Talocrural joint congruence
Description
Medial clear space < 4 mm and ≤ 1 mm wider than the superior clear space as measured between the lateral border of the medial malleolus and the medial border of the talus at the level of the talar dome.
Time Frame
At two, six and 12 weeks, and at 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Weber B unimalleolar ankle fracture Age: 16 years or older Voluntary Operated within 7 days of the trauma Walking without aid before accident Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harri J Pakarinen, MD, PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tero HJ Kortekangas, MD, PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
OYS, Oulu university hospital, Department of orthopedic and traumatology
City
Oulu
State/Province
Pohjois-Pohjanmaa
ZIP/Postal Code
90100
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Trial data are not publicly available owing to data privacy, but access to the anonymised dataset can be obtained from the corresponding author on reasonable request.

Learn more about this trial

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

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