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

Primary Purpose

Ankle Fracture, Bimalleolar, Ankle Fracture, Trimalleolar

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Non-operative treatment
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fracture, Bimalleolar

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Østfold Hospital TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-operative treatment

Arm Description

Non-operative treatment based on weightbearing radiographs

Outcomes

Primary Outcome Measures

Olerud Molander Score (OMAS) to measure a change over time
Condition specific, patient reported measure of ankle-fracture symptoms

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2023
Last Updated
August 7, 2023
Sponsor
Ostfold Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05765929
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ostfold Hospital Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fracture, Bimalleolar, Ankle Fracture, Trimalleolar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-operative treatment
Arm Type
Experimental
Arm Description
Non-operative treatment based on weightbearing radiographs
Intervention Type
Other
Intervention Name(s)
Non-operative treatment
Intervention Description
Patients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated
Primary Outcome Measure Information:
Title
Olerud Molander Score (OMAS) to measure a change over time
Description
Condition specific, patient reported measure of ankle-fracture symptoms
Time Frame
6 week, 12 weeks, 1year, 2 years
Secondary Outcome Measure Information:
Title
Manchester-Oxford Foot Questionnaire (MOxFQ)
Description
Patients reported outcomes
Time Frame
6 week, 12 weeks, 1year, 2 years
Title
Range of Motion measured by a goniometer (ad modum Lindsjo)
Description
dorsiflexion and plantarflexion
Time Frame
6 week, 12 weeks, 1year, 2 years
Title
Numeric Rating Scale (NRS)
Description
Ankle pain in rest, at night and in daily activities, a 11-point numeric scale ranging from 0-10
Time Frame
6 week, 12 weeks, 1year, 2 years
Title
Euroqol questionnaire (EQ- 5D)
Description
Health related quality of life
Time Frame
6 week, 12 weeks, 1year, 2 years
Title
Registrations of complications/adverse events
Description
Registration of loss of congruence, delayed union, non-union, thromboembolic events
Time Frame
0-2 years
Title
Posttraumatic osteoarthritis (OA)
Description
CT-scan (Kellgren-Lawrence classification)
Time Frame
2 years and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marius Molund, PhD
Phone
0047 90093988
Email
mariusmolund@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Silje Karlsen
Phone
0047 90761773
Email
silje-karlsen@hotmail.com
Facility Information:
Facility Name
Østfold Hospital Trust
City
Sarpsborg
State/Province
Østfold
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marius Molund, MD, PhD
Phone
+4790093988
Email
marius.molund@so-hf.no
First Name & Middle Initial & Last Name & Degree
Grûn, MD
Email
wolfram.grun@so-hf.no

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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