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Lateral Malleolus FracturesNCT03831009

Weight-bearing Radiographs to Evaluate Stability in Ankles With Isolated Weber Type B Fractures.

A study testing Open reduction internal fixation (ORIF) and Conservative treatment in people with Lateral Malleolus Fractures and Ankle Fractures, run by Ostfold Hospital Trust at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators will conduct a prospective cohort study on the use of weight-bearing radiographs to evaluate stability in ankles with isolated, trans-syndesmotic (Weber type B) fibular fractures. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lateral Malleolus Fractures, Ankle Fractures
What is being tested?
Open reduction internal fixation (ORIF) and Conservative treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
1 siteNorway
Study dates
1 Jan 2019to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Isolated Weber type B fractures without radiological signs of medial clear space widening on initial radiographs. Patients must be 18-80 years of age. Before the injury patients should be mobilized without walking aids. They should be compliant with good communication skills in the Norwegian or English languages. Patients must live in Østfold or nearby areas so they are able to meet to follow-up consultations.

Who cannot join

  • Patients presenting with any of the following will be excluded from the study: Fracture of the medial malleolus. Information about prehospital fracture closed reduction. Open fracture. Fracture resulting from high-energy trauma or multi-trauma. Pathologic fracture. Diabetes Mellitus type 1 and 2. Neuropathies. Cognitive disorders. Previous history of ankle fracture. Previous history of ankle-/foot surgery. Generalized joint disease such as RA. Patients with insufficient Norwegian or English language proficiency or lack of communication skills.

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Østfold Hospital Trust

    Sarpsborg, Østfold fylke, 1714

Other trials in Norway

About this study

Official title: Weight-bearing Radiographs to Evaluate Stability in Ankles With Isolated Trans-syndesmotic Lateral Malleolar (Weber Type B) Fractures. A Pilot Study.

The investigators will conduct a prospective cohort study on the use of weight-bearing radiographs to evaluate stability in ankles with isolated, trans-syndesmotic (Weber type B) fibular fractures. Stable fractures will be treated conservatively using a functional brace, unstable fractures will undergo surgical fixation.

Read the detailed description

It is widely accepted that fractures in stable ankles can be treated non-operatively and fractures in unstable ankles needs internal fixation surgery (Michelson, Magid \& McHale, 2007, Gougoulias, Khanna, Seellariou, Maffulli, 2010). Clinical decision-making is thus based on ankle stability evaluation. The integrity of medial structures, mainly the deep deltoid ligament, is considered the most important determinant for stability of the ankle mortise (Michelson, Magid \& McHale, 2007, Gougoulias, Khanna, Seellariou, Maffulli, 2010). Weber B fractures, with no obvious sign of medial side injury on initial plain radiographs, have to be considered of uncertain stability until adequate stress testing is performed.

Currently there is no definite consensus on what test(s) best determines stability in ankles with undisplaced, isolated lateral malleolar fractures. Much used methods comprises manual stress radiographs and gravity stress radiographs (McConnel, Creevy \& Tornetta, 2004). However recent studies have shown that such methods overestimate the need for surgical fixation indicating the need for a different method to make up the basis for surgical indication (Dawe, Shafafy, Quayle, Gougoulias, Wee \& Sakellariou, 2015, Hastie, Akhtar, Butt, Baumann \& Barrie, 2015, Holmes, Acker, Murphy, McKinney, Kadakia \& Irwin, 2016, Hoshino, Nomoto, Norheim \& Harris, 2012, Koval, Egol, Cheung, Goodwin \& Spratt (2007), Seidel et al., 2017, Weber, Burmeister, Flueckiger \& Krause, 2010). Authors of recent studies have proposed weightbearing radiographs as an alternative method to distinguish stable and unstable fractures, significantly reducing the need for operative treatment (Dawe et al., 2015, Hastie et al., 2015, Hoshino et al, 2012, Holmes et al., 2016, Seidel et al., 2017, Weber et al. 2010).

To evaluate weight-bearing radiographs ability to determine stability our primary focus is to evaluate if conservative treatment for "gravity unstable/weightbearing stable" ankles produces different outcomes than conservative treatment for "gravity stable/weightbearing stable" ankles.

Participants will be assigned to non-operative or surgical treatment based on ankle stability evaluation using results from weightbearing radiographs consistently. Stable ankles will be treated non-operatively with a functional brace (AirCast) for 6 weeks. Participants will be instructed to bear weight as tolerated and to actively do standardized range-of-motion exercises. Standard operative treatment is open reduction and internal fixation of the fracture using plate and screws.

Being tested
Open reduction internal fixation (ORIF), Conservative treatment
Medical subject headings
Ankle Fractures

What participants receive

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

  • Open reduction internal fixation (ORIF)Procedure or surgery

    Open fracture reduction followed by internal fixation using a plate and screws. The goal is an osteosynthesis that allow for early range-of-motion exercises, but weightbearing is usually not tolerated until 6 weeks postoperatively.

  • Conservative treatmentOther

    Conservative treatment involves ankle protection with a functional brace (AirCast) for 6 weeks. Participants will be instructed to bear weight as tolerated and to actively do standardized range-of-motion exercises.

Study groups in NCT03831009
Study groupRoleWhat they receive
Weight-bearing stable/Gravity stableActive comparatorAnkles that are considered stable using weight-bearing radiographs AND gravity stress test will be assigned to conservative treatment
Receives: Other: Conservative treatment
Weight-bearing stable/Gravity unstableActive comparatorAnkles that are considered stable using weight-bearing radiographs but unstable using gravity stress test will be assigned to conservative treatment
Receives: Other: Conservative treatment
Weight-bearing unstable/Gravity unstableActive comparatorAnkles that are considered unstable using weight-bearing radiographs AND gravity stress test will be assigned to open reduction internal fixation (ORIF)
Receives: Procedure: Open reduction internal fixation (ORIF)
Weight-bearing unstable/Gravity stableActive comparatorAnkles that are considered unstable using weight-bearing radiographs but stable using gravity stress test will be assigned to open reduction internal fixation (ORIF)
Receives: Procedure: Open reduction internal fixation (ORIF)

What is being measured

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

  1. The Manchester-Oxford Foot Questionnaire (MOxFQ)

    Ankle/foot specific patient-reported outcome measure

    Measured: 24 months

Secondary outcomes (8)
  1. Olerud-Molander Ankle Score (OMAS)

    Ankle/foot specific patient-reported outcome measure. Maximum score (100) = best. Minimum score = 0 (worst). Poor = 0-30, Fair = 31-60, Good = 61-90, Excellent = 91-100. Presented as total score (0-100).

    Measured: 24 months

  2. AOFAS ankle-hindfoot

    Ankle/foot specific patient-reported outcome measure

    Measured: 24 months

  3. VAS/NRS of pain

    Visual analogue pain scale - patient reported. Scale 0-10. 10 = worst possible pain, 0 = no pain

    Measured: 24 months

  4. Eq-5d

    Genereic health related quality of life patient reported outcome measure

    Measured: 24 months

  5. Fracture healing

    Radiographic result

    Measured: 24 months

  6. Registration of complications

    Yes/No for malalignment, deep vein trobosis, nerve injury, wound infection, delayed wound healing and crossover to surgery (including reason for crossover).

    Measured: 24 months

  7. Bilateral ankle range-of-motion

    Measured in degrees with a goniometer ad modum Lindsjö.

    Measured: 24 months

  8. Bilateral calf circumference

    Calf circumference in centimeters measured 10 cm distal to the tibial tubercle Calf circumference in centimeters measured 10 cm distal to the tibial tubercle using measuring tape

    Measured: 24 months

Timeline

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

  1. First posted5 Feb 2019
  2. Study start1 Jan 2019
  3. Primary completion30 Jun 2022
  4. Study completion31 Dec 2022

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Two-arm parallel assignment. Based on stability evaluation using weight-bearing adiographs one group recieves surgery, one group recieves non-surgical treatment.
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03831009
Sponsor's protocol ID
18/07031-7
Other IDs
2018/1585/REK sør-øst B
Status last verified
Jun 2022
First submitted
4 Feb 2019
Last updated
19 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Open reduction internal fixation (ORIF) and Conservative treatment in people with Lateral Malleolus Fractures and Ankle Fractures, run by Ostfold Hospital Trust at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The Manchester-Oxford Foot Questionnaire (MOxFQ) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Jan 2023.

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