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

Not Applicable

Recruiting

• Conditions: Ankle Fracture, Bimalleolar; Ankle Fracture, Trimalleolar
• Interventions: Other: Non-operative treatment

• Registration Number: NCT05765929
• Lead Sponsor: Ostfold Hospital Trust

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2023-02-27
• Study Start: 2023-02-28
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-13
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08
• Primary Completion: 2027-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-operative treatment	Non-operative treatment	Non-operative treatment based on weightbearing radiographs

Primary Outcome Measures

Name	Time	Method
Olerud Molander Score (OMAS) to measure a change over time	6 week, 12 weeks, 1year, 2 years	Condition specific, patient reported measure of ankle-fracture symptoms

Secondary Outcome Measures

Name	Time	Method
Posttraumatic osteoarthritis (OA)	2 years and 5 years	CT-scan (Kellgren-Lawrence classification)
Manchester-Oxford Foot Questionnaire (MOxFQ)	6 week, 12 weeks, 1year, 2 years	Patients reported outcomes
Range of Motion measured by a goniometer (ad modum Lindsjo)	6 week, 12 weeks, 1year, 2 years	dorsiflexion and plantarflexion
Euroqol questionnaire (EQ- 5D)	6 week, 12 weeks, 1year, 2 years	Health related quality of life
Registrations of complications/adverse events	0-2 years	Registration of loss of congruence, delayed union, non-union, thromboembolic events
Numeric Rating Scale (NRS)	6 week, 12 weeks, 1year, 2 years	Ankle pain in rest, at night and in daily activities, a 11-point numeric scale ranging from 0-10

Trial Locations

Locations (1)

Østfold Hospital Trust; 🇳🇴 Sarpsborg, Østfold, Norway