Use of Weightbearing Radiographs to Determine Treatment o... | NCT05765929

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

NCT05765929

Sponsor

Ostfold Hospital Trust

Status

Recruiting

Last Update Posted

Aug 8, 2023Actual

Enrollment

29Estimated

Phase

Not Applicable

Conditions

Ankle Fracture, Bimalleolar
Ankle Fracture, Trimalleolar

Interventions

Non-operative treatment

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2023Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2032Estimated

First Submitted Date

Feb 27, 2023

First Submission Date that Met QC Criteria

Mar 9, 2023

First Posted Date

Mar 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2023

Last Update Posted Date

Aug 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-operative treatment	Experimental	Non-operative treatment based on weightbearing radiographs	Other: Non-operative treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-operative treatment	Other	Patients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated	Non-operative treatment

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Marius Molund, PhD	Contact	0047 90093988		mariusmolund@hotmail.com
Silje Karlsen	Contact	0047 90761773		silje-karlsen@hotmail.com

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D016512	Ankle Injuries
D007869	Leg Injuries