Active, not recruitingNCT05765929ClinicalTrials.gov record

Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures

Ankle Fracture, Bimalleolar · Ankle Fracture, Trimalleolar

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - 75 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 29 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

-With bi- and trimalleolar ankle fractures with less than 7 mm medial clear space on non-weightbearing radiographs that are deemed stable by weightbearing radiographs.
With type B medial malleolus fractures between the tip and the plafond and type C medial malleolus fractures at the level of the plafond (Herscovici classification). (6)
With fractures in the distal 1/3 of fibula (not-Maisonneuve)
Enabling stability evaluation within 14 days after injury
18-75 years of age
with pre-injury walking ability without aids

Exclusion Criteria:

\- With primary unstable ankle fractures, \> 7mm medial clear space on primary radiographs
With fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and pathological fracture
With type A medial malleolus avulsion fractures \< 5mm (at the tip of the malleolus), that are not suitable for surgical intervention.
With Herscovici type D fractures, involving Lauge-Hansen SA2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the plafond)
With displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon
With neuropathies and symptomatic joint diseases such as Rheumatoid Arthritis
That are assumed not compliant (such as drug abuse, cognitive- and/or psychiatric disorders)
With previous history ipsilateral ankle fracture
With previous history ipsilateral major ankle-/foot surgery
Who live outside the hospital catchment areas not available to follow up
With insufficient Norwegian or English language skills
Non-compliant

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

Non-operative treatment

Non-operative treatment based on weightbearing radiographs

Other: Non-operative treatment

Non-operative treatment OTHER

Patients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated

Prepare your questions