Clinical trial NCT05765929: Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures
Official title: Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankle Fracture, Bimalleolar
Ankle Fracture, Trimalleolar
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Olerud Molander Score (OMAS) to measure a change over time
timeFrame: 6 week, 12 weeks, 1year, 2 years
Secondary outcomes:
measure: Manchester-Oxford Foot Questionnaire (MOxFQ)
timeFrame: 6 week, 12 weeks, 1year, 2 years
measure: Range of Motion measured by a goniometer (ad modum Lindsjo)
timeFrame: 6 week, 12 weeks, 1year, 2 years
measure: Numeric Rating Scale (NRS)
timeFrame: 6 week, 12 weeks, 1year, 2 years
measure: Euroqol questionnaire (EQ- 5D)
timeFrame: 6 week, 12 weeks, 1year, 2 years
measure: Registrations of complications/adverse events
timeFrame: 0-2 years
measure: Posttraumatic osteoarthritis (OA)
timeFrame: 2 years and 5 years
Other outcomes:
Locations:
city: Sarpsborg
country: Norway
facility: Østfold Hospital Trust
state: Østfold
Study officials:
References: