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

Non-operative Versus Operative Treatment of Suprasyndesmotic Ankle Fractures: A Prospective, Multicentre, Randomised Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ankle Fractures
• Intervention / Treatment: Procedure: Surgical treatment; Device: Ankle orthosis

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Håvard Furunes, PhD; Phone Number: +47 99041763; Email: havardfurunes@gmail.com
• Study Contact Backup: Name: Ola Saatvedt, MD; Phone Number: +47 45404066; Email: ola.saatvedt@gmail.com

Study Locations

• Norway
  • Oslo, Norway, 4950
    • Oslo University Hospital
  • Innlandet
    • Gjøvik, Innlandet, Norway, 2819
      • Sykehuset Innlandet HF
  • Viken
    • Bærums Verk, Viken, Norway, 1347
      • Vestre Viken Hospital Trust
    • Fredrikstad, Viken, Norway, 1714
      • Østfold Hospital Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgical treatment; 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.	Procedure: Surgical treatment; Surgical treatment of suprasyndesmotic ankle fractures
Experimental: Non-surgical treatment; 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.	Device: Ankle orthosis; Non-surgical treatment of suprasyndesmotic ankle fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The main statistical analysis of the primary outcome will be based on the two-year follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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").	The main statistical analysis of the outcome will be based on the two-year follow-up.
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.	The main statistical analysis of the outcome will be based on the two-year follow-up.
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).	The main statistical analysis of the outcome will be based on the two-year follow-up.
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.	The main statistical analysis of the outcome will be based on the two-year follow-up.
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.	The main statistical analysis of the outcome will be based on the two-year follow-up.
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.	The main statistical analysis of the outcome will be based on the two-year follow-up.

Collaborators and Investigators

• Sponsor: Sykehuset Innlandet HF
• Collaborators: Vestre Viken Hospital Trust; Oslo University Hospital; Ostfold Hospital Trust
• Investigators: Principal Investigator: Håvard Furunes, PhD, Sykehuset Innlandet HF

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2020
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Estimated): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: surgical treatment; conservative treatment; weight-bearing; ankle fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: 169307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We have planned to use all the IPD only within the present study group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No