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

Ankle Fracture, Bimalleolar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05765929
• Other study ID #: 47891
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: December 31, 2032

Study information

• Verified date: November 2022
• Source: Ostfold Hospital Trust
• Contact: Marius Molund, PhD
• Phone: 0047 90093988
• Email: mariusmolund[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fracture, Bimalleolar
• Ankle Fracture, Trimalleolar
• Ankle Fractures
• Fractures, Bone

Intervention

Other:
• Non-operative treatment
Patients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated

Locations

Country	Name	City	State
Norway	Østfold Hospital Trust	Sarpsborg	Østfold

Sponsors (1)

Lead Sponsor	Collaborator
Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Olerud Molander Score (OMAS) to measure a change over time	Condition specific, patient reported measure of ankle-fracture symptoms	6 week, 12 weeks, 1year, 2 years
Secondary	Manchester-Oxford Foot Questionnaire (MOxFQ)	Patients reported outcomes	6 week, 12 weeks, 1year, 2 years
Secondary	Range of Motion measured by a goniometer (ad modum Lindsjo)	dorsiflexion and plantarflexion	6 week, 12 weeks, 1year, 2 years
Secondary	Numeric Rating Scale (NRS)	Ankle pain in rest, at night and in daily activities, a 11-point numeric scale ranging from 0-10	6 week, 12 weeks, 1year, 2 years
Secondary	Euroqol questionnaire (EQ- 5D)	Health related quality of life	6 week, 12 weeks, 1year, 2 years
Secondary	Registrations of complications/adverse events	Registration of loss of congruence, delayed union, non-union, thromboembolic events	0-2 years
Secondary	Posttraumatic osteoarthritis (OA)	CT-scan (Kellgren-Lawrence classification)	2 years and 5 years