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Ankle FracturesNCT04615650

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

A study testing Surgical treatment and Ankle orthosis in people with Ankle Fractures, run by Sykehuset Innlandet HF at 4 sites in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Ankle Fractures
What is being tested?
Surgical treatment and Ankle orthosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
4 sitesNorway
Study dates
28 Dec 2020to Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

4 sites in 1 country.

Norway4 sites

  • Vestre Viken Hospital Trust

    Bærums verk, Akershus, 1347

  • Østfold Hospital Trust

    Fredrikstad, Akershus, 1714

  • Sykehuset Innlandet HF

    Gjøvik, Innlandet, 2819

  • Oslo University Hospital

    Oslo, Oslo, 4950

Other trials in Norway

About this study

Official title: 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.

Read the 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.

Conditions
Ankle Fractures
Being tested
Surgical treatment, Ankle orthosis
Keywords
ankle fractures, surgical treatment, conservative treatment, weight-bearing
Medical subject headings
Ankle Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgical treatmentProcedure or surgery

    Surgical treatment of suprasyndesmotic ankle fractures

  • Ankle orthosisDevice

    Non-surgical treatment of suprasyndesmotic ankle fractures

Study groups in NCT04615650
Study groupRoleWhat they receive
Surgical treatmentActive comparatorPatients 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.
Receives: Procedure: Surgical treatment
Non-surgical treatmentExperimentalPatients 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.
Receives: Device: Ankle orthosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: The main statistical analysis of the primary outcome will be based on the two-year follow-up.

Secondary outcomes (6)

  1. 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").

    Measured: The main statistical analysis of the outcome will be based on the two-year follow-up.

  2. 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.

    Measured: The main statistical analysis of the outcome will be based on the two-year follow-up.

  3. 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).

    Measured: The main statistical analysis of the outcome will be based on the two-year follow-up.

  4. 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.

    Measured: The main statistical analysis of the outcome will be based on the two-year follow-up.

  5. 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.

    Measured: The main statistical analysis of the outcome will be based on the two-year follow-up.

  6. 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.

    Measured: The main statistical analysis of the outcome will be based on the two-year follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2020
  2. Study start28 Dec 2020
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised controlled multicentre trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04615650
Sponsor's protocol ID
169307
Status last verified
May 2025
First submitted
28 Oct 2020
Last updated
16 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We have planned to use all the IPD only within the present study group.

Publications

  • Saatvedt O, Riiser M, Frihagen F, Figved W, Madsen JE, Molund M, Furunes H. Non-operative versus operative treatment of suprasyndesmotic ankle fractures: protocol for a prospective, multicentre, randomised controlled trial. BMJ Open. 2024 Jan 8;14(1):e075122. doi: 10.1136/bmjopen-2023-075122.

    PubMed 38191245

Questions about this trial

What is this clinical trial studying?

A study testing Surgical treatment and Ankle orthosis in people with Ankle Fractures, run by Sykehuset Innlandet HF at 4 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Olerud-Molander Ankle Score (OMAS) (time frame: The main statistical analysis of the primary outcome will be based on the two-year follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04615650, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.

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