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

Ostfold Hospital Trust

Status: Enrolling

Conditions: Ankle Fracture, Trimalleolar; Ankle Fracture, Bimalleolar

Treatments: Other: Non-operative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05765929

47891

Details and patient eligibility

About

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

Enrollment: 29 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Non-operative treatment

Experimental group

Description:

Non-operative treatment based on weightbearing radiographs

Treatment:

Other: Non-operative treatment