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

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

Study Overview

• Status: Recruiting
• Conditions: Ankle Fracture, Trimalleolar; Ankle Fracture, Bimalleolar
• Intervention / Treatment: Other: Non-operative treatment

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marius Molund, PhD; Phone Number: 0047 90093988; Email: mariusmolund@hotmail.com
• Study Contact Backup: Name: Silje Karlsen; Phone Number: 0047 90761773; Email: silje-karlsen@hotmail.com

Study Locations

• Norway
  • Østfold
    • Sarpsborg, Østfold, Norway, 1714
      • Recruiting
      • Østfold Hospital Trust
      • Contact: Marius Molund, MD, PhD; Phone Number: +4790093988; Email: marius.molund@so-hf.no
      • Contact: Grûn, MD; Email: wolfram.grun@so-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-operative treatment; Non-operative treatment based on weightbearing radiographs	Other: Non-operative treatment; Patients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manchester-Oxford Foot Questionnaire (MOxFQ)	Patients reported outcomes	6 week, 12 weeks, 1year, 2 years
Range of Motion measured by a goniometer (ad modum Lindsjo)	dorsiflexion and plantarflexion	6 week, 12 weeks, 1year, 2 years
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
Euroqol questionnaire (EQ- 5D)	Health related quality of life	6 week, 12 weeks, 1year, 2 years
Registrations of complications/adverse events	Registration of loss of congruence, delayed union, non-union, thromboembolic events	0-2 years
Posttraumatic osteoarthritis (OA)	CT-scan (Kellgren-Lawrence classification)	2 years and 5 years

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: 47891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No