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Completed

NCT Number: NCT03831009

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Østfold Hospital Trust

Sarpsborg, Østfold fylke, 1714, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Open reduction internal fixation (ORIF)

Procedure

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 treatment

Other

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.

Primary outcomes

  1. The Manchester-Oxford Foot Questionnaire (MOxFQ)

    Time frame: 24 months

    Ankle/foot specific patient-reported outcome measure

Secondary outcomes

  1. Olerud-Molander Ankle Score (OMAS)

    Time frame: 24 months

    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).

  2. AOFAS ankle-hindfoot

    Time frame: 24 months

    Ankle/foot specific patient-reported outcome measure

  3. VAS/NRS of pain

    Time frame: 24 months

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

  4. Eq-5d

    Time frame: 24 months

    Genereic health related quality of life patient reported outcome measure

  5. Fracture healing

    Time frame: 24 months

    Radiographic result

  6. Registration of complications

    Time frame: 24 months

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

  7. Bilateral ankle range-of-motion

    Time frame: 24 months

    Measured in degrees with a goniometer ad modum Lindsjö.

  8. Bilateral calf circumference

    Time frame: 24 months

    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

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2019
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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