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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03831009
Enrollment
151
Registered
2019-02-05
Start date
2019-01-01
Completion date
2022-12-31
Last updated
2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fractures, Lateral Malleolus Fractures

Brief 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. Stable fractures will be treated conservatively using a functional brace, unstable fractures will undergo surgical fixation.

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.

Interventions

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.

OTHERConservative treatment

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.

Sponsors

Ostfold Hospital Trust
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Two-arm parallel assignment. Based on stability evaluation using weight-bearing adiographs one group recieves surgery, one group recieves non-surgical treatment.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The Manchester-Oxford Foot Questionnaire (MOxFQ)24 monthsAnkle/foot specific patient-reported outcome measure

Secondary

MeasureTime frameDescription
AOFAS ankle-hindfoot24 monthsAnkle/foot specific patient-reported outcome measure
VAS/NRS of pain24 monthsVisual analogue pain scale - patient reported. Scale 0-10. 10 = worst possible pain, 0 = no pain
Eq-5d24 monthsGenereic health related quality of life patient reported outcome measure
Olerud-Molander Ankle Score (OMAS)24 monthsAnkle/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).
Registration of complications24 monthsYes/No for malalignment, deep vein trobosis, nerve injury, wound infection, delayed wound healing and crossover to surgery (including reason for crossover).
Bilateral ankle range-of-motion24 monthsMeasured in degrees with a goniometer ad modum Lindsjö.
Bilateral calf circumference24 monthsCalf 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
Fracture healing24 monthsRadiographic result

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026