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RCT Comparing Non-operative vs Operative Treatment of Suprasyndesmotic Ankle Fractures.

Primary Purpose

Ankle Fractures

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Surgical treatment
Ankle orthosis
Sponsored by
Sykehuset Innlandet HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures focused on measuring ankle fractures, surgical treatment, conservative treatment, weight-bearing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients who present with a closed, isolated fibular fracture classified as suprasyndesmotic (Weber C) with a medial clear space of less than 7 mm in mortise view on primary radiographs.
  • presentation less than 14 days after the injury.

Exclusion Criteria:

  • previous fractures or ligamentous injury to the injured ankle.
  • pathological fracture.
  • diabetic neuropathy or other neuropathies.
  • drug abuse.
  • inability to consent and/or comply.
  • inability to understand Norwegian language.
  • inability to walk unaided prior to the fracture.
  • patients with a concomitant tibial fracture requiring surgical treatment are excluded, but patients with undisplaced concomitant tibial fractures can be included.
  • patients from outside the catchment area of the recruiting hospitals. However, they can be included if they are willing to undergo follow-up visits at one of the recruiting hospitals.

Sites / Locations

  • Sykehuset Innlandet HF
  • Vestre Viken Hospital Trust
  • Østfold Hospital Trust
  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Surgical treatment

Non-surgical treatment

Arm Description

Patients randomised to operative treatment will have their surgery performed by an orthopaedic surgeon or by orthopaedic trainees under the supervision of a consultant, when fit for surgery. The surgical technique and choice of implants will be decided by the surgeon in order to closely resemble everyday clinical practice. The syndesmosis must be reduced (closed or open) and fixed. Postoperatively, the patients will be treated with an ankle orthosis for six weeks with weight-bearing as tolerated.

Patients randomised to non-operative treatment are treated with an ankle orthosis for six weeks with weight-bearing as tolerated. Other types of casts can be used if preferred by the treating orthopaedic surgeon, but the cast must allow full weight-bearing and must prevent equinus position.

Outcomes

Primary Outcome Measures

Olerud-Molander Ankle Score (OMAS)
The primary outcome measure is the Olerud-Molander Ankle Score (OMAS), which is a condition-specific, patient-reported measure of ankle-fracture symptoms. OMAS ranges from 0 to 100, with higher scores indicating better outcomes and fewer symptoms.

Secondary Outcome Measures

Ankle pain
Ankle pain is measured by the Numeric Rating Scale (NRS), which is an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst pain imaginable").
Manchester-Oxford Foot Questionnaire (MOxFQ)
Ankle-related symptoms are, in addition to the OMAS questionnaire, measured by the Manchester-Oxford Foot Questionnaire (MOxFQ). The MOxFQ is a 16-item questionnaire consisting of three subscales: walking/standing (w/s) problems (seven items), pain (p) (five items), and issues related to social interaction (si) (four items). Patients score each question on a five-point Likert scale ranging from 0 to 4, with 4 representing the worst stage. Raw scores are converted to a numeric scale ranging from 0 to 100, with 100 denoting the most severe symptoms.
EuroQol questionnaire (EQ-5D)
Quality of life is measured by the EuroQol questionnaire (EQ-5D). EQ-5D is a validated generic health-related quality-of-life instrument. It consists of two parts: EQ-5D descriptive part and EQ-5D visual analogue scale. The descriptive part in-cludes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxie-ty/depression), each with three possible answers ("no problems", "some problems", and "major problems"). EQ-5D VAS is a visual analogue scale of self-related overall health, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Radiographic results
Radiographic results (fracture healing, joint congruency, syndesmotic reduction and post-traumatic arthritis) is assessed by plain radiographs and computed tomography (CT). Post-traumatic arthritis is graded on radiographs according to van Dijk et.al.
Range of motion
Range of motion of both ankles will be assessed by a physiotherapist or surgeon (who are not directly involved in the study) using a goniometer to measure active loaded dorsiflexion.
Adverse events
Adverse events, including deep vein thrombosis, nerve injury, wound infection and other complications occurring during the 24 months of follow-up are registered. Reoperations and crossover from non-operative to operative treatment are also registered.

Full Information

First Posted
October 28, 2020
Last Updated
May 30, 2023
Sponsor
Sykehuset Innlandet HF
Collaborators
Oslo University Hospital, Vestre Viken Hospital Trust, Ostfold Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04615650
Brief Title
RCT Comparing Non-operative vs Operative Treatment of Suprasyndesmotic Ankle Fractures.
Official Title
Non-operative Versus Operative Treatment of Suprasyndesmotic Ankle Fractures: A Prospective, Multicentre, Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sykehuset Innlandet HF
Collaborators
Oslo University Hospital, Vestre Viken Hospital Trust, Ostfold Hospital Trust

4. Oversight

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

5. Study Description

Brief Summary
Weight-bearing radiographs will be used to evaluate the stability of suprasyndesmotic ankle fractures. Patients with stable fractures will be randomised to operative or non-operative treatment.
Detailed Description
Suprasyndesmotic fractures (Weber type C) are historically treated operatively because of the assumption that the distal tibiofibular syndesmosis is ruptured, leading to joint instability (Lauge-Hansen 1950, Boden 1989). However, the medial deltoid ligament may function as the main stabiliser of the ankle joint by preventing external rotation of the talus and therefore maintains the dynamic congruity (Michelson 2007). Due to the stabilising effect of the deltoid ligament, an increasing number of transsyndesmotic fractures (Weber type B) are treated non-operatively with excellent results and without the burden of complications that accompany surgery (Gougoulias 2017, Mittal 2017, Bauer 1985). The aims of the present study are to test the stability of suprasyndesmotic ankle fractures on weight-bearing radiographs and to evaluate the effect of non-operative versus operative treatment of stable suprasyndesmotic fractures. The patients will have a weight-bearing (at least 50% of body weight) standing radiograph for the evaluation of the stability of the fracture. Patients with a congruent ankle mortise (i.e., stable fracture) on weight-bearing radiographs will be randomised to either operative (ORIF, reference treatment) or non-operative treatment (cast). Patients in both groups are allowed full weight-bearing. Patients with an incongruent ankle mortise (i.e., unstable fracture) will be treated operatively according to current clinical practice and included in a parallel observational cohort study. Patients who are unwilling to participate in the intervention study are also invited to participate in the observational cohort study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures
Keywords
ankle fractures, surgical treatment, conservative treatment, weight-bearing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled multicentre trial
Masking
Outcomes Assessor
Masking Description
Data will be plotted into a database by an independent blinded data manager.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical treatment
Arm Type
Active Comparator
Arm Description
Patients randomised to operative treatment will have their surgery performed by an orthopaedic surgeon or by orthopaedic trainees under the supervision of a consultant, when fit for surgery. The surgical technique and choice of implants will be decided by the surgeon in order to closely resemble everyday clinical practice. The syndesmosis must be reduced (closed or open) and fixed. Postoperatively, the patients will be treated with an ankle orthosis for six weeks with weight-bearing as tolerated.
Arm Title
Non-surgical treatment
Arm Type
Experimental
Arm Description
Patients randomised to non-operative treatment are treated with an ankle orthosis for six weeks with weight-bearing as tolerated. Other types of casts can be used if preferred by the treating orthopaedic surgeon, but the cast must allow full weight-bearing and must prevent equinus position.
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment
Intervention Description
Surgical treatment of suprasyndesmotic ankle fractures
Intervention Type
Device
Intervention Name(s)
Ankle orthosis
Intervention Description
Non-surgical treatment of suprasyndesmotic ankle fractures
Primary Outcome Measure Information:
Title
Olerud-Molander Ankle Score (OMAS)
Description
The primary outcome measure is the Olerud-Molander Ankle Score (OMAS), which is a condition-specific, patient-reported measure of ankle-fracture symptoms. OMAS ranges from 0 to 100, with higher scores indicating better outcomes and fewer symptoms.
Time Frame
The main statistical analysis of the primary outcome will be based on the two-year follow-up.
Secondary Outcome Measure Information:
Title
Ankle pain
Description
Ankle pain is measured by the Numeric Rating Scale (NRS), which is an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst pain imaginable").
Time Frame
The main statistical analysis of the outcome will be based on the two-year follow-up.
Title
Manchester-Oxford Foot Questionnaire (MOxFQ)
Description
Ankle-related symptoms are, in addition to the OMAS questionnaire, measured by the Manchester-Oxford Foot Questionnaire (MOxFQ). The MOxFQ is a 16-item questionnaire consisting of three subscales: walking/standing (w/s) problems (seven items), pain (p) (five items), and issues related to social interaction (si) (four items). Patients score each question on a five-point Likert scale ranging from 0 to 4, with 4 representing the worst stage. Raw scores are converted to a numeric scale ranging from 0 to 100, with 100 denoting the most severe symptoms.
Time Frame
The main statistical analysis of the outcome will be based on the two-year follow-up.
Title
EuroQol questionnaire (EQ-5D)
Description
Quality of life is measured by the EuroQol questionnaire (EQ-5D). EQ-5D is a validated generic health-related quality-of-life instrument. It consists of two parts: EQ-5D descriptive part and EQ-5D visual analogue scale. The descriptive part in-cludes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxie-ty/depression), each with three possible answers ("no problems", "some problems", and "major problems"). EQ-5D VAS is a visual analogue scale of self-related overall health, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
The main statistical analysis of the outcome will be based on the two-year follow-up.
Title
Radiographic results
Description
Radiographic results (fracture healing, joint congruency, syndesmotic reduction and post-traumatic arthritis) is assessed by plain radiographs and computed tomography (CT). Post-traumatic arthritis is graded on radiographs according to van Dijk et.al.
Time Frame
The main statistical analysis of the outcome will be based on the two-year follow-up.
Title
Range of motion
Description
Range of motion of both ankles will be assessed by a physiotherapist or surgeon (who are not directly involved in the study) using a goniometer to measure active loaded dorsiflexion.
Time Frame
The main statistical analysis of the outcome will be based on the two-year follow-up.
Title
Adverse events
Description
Adverse events, including deep vein thrombosis, nerve injury, wound infection and other complications occurring during the 24 months of follow-up are registered. Reoperations and crossover from non-operative to operative treatment are also registered.
Time Frame
The main statistical analysis of the outcome will be based on the two-year follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients who present with a closed, isolated fibular fracture classified as suprasyndesmotic (Weber C) with a medial clear space of less than 7 mm in mortise view on primary radiographs. presentation less than 14 days after the injury. Exclusion Criteria: previous fractures or ligamentous injury to the injured ankle. pathological fracture. diabetic neuropathy or other neuropathies. drug abuse. inability to consent and/or comply. inability to understand Norwegian language. inability to walk unaided prior to the fracture. patients with a concomitant tibial fracture requiring surgical treatment are excluded, but patients with undisplaced concomitant tibial fractures can be included. patients from outside the catchment area of the recruiting hospitals. However, they can be included if they are willing to undergo follow-up visits at one of the recruiting hospitals.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Håvard Furunes, PhD
Organizational Affiliation
Sykehuset Innlandet HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sykehuset Innlandet HF
City
Gjøvik
State/Province
Innlandet
ZIP/Postal Code
2819
Country
Norway
Facility Name
Vestre Viken Hospital Trust
City
Bærums Verk
State/Province
Viken
ZIP/Postal Code
1347
Country
Norway
Facility Name
Østfold Hospital Trust
City
Fredrikstad
State/Province
Viken
ZIP/Postal Code
1714
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
4950
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We have planned to use all the IPD only within the present study group.

Learn more about this trial

RCT Comparing Non-operative vs Operative Treatment of Suprasyndesmotic Ankle Fractures.

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