NCT05765929

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
81mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Feb 2023Dec 2032

First Submitted

Initial submission to the registry

February 27, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

August 8, 2023

Status Verified

November 1, 2022

Enrollment Period

4.8 years

First QC Date

February 27, 2023

Last Update Submit

August 7, 2023

Conditions

Ankle Fracture, BimalleolarAnkle Fracture, Trimalleolar

Outcome Measures

Primary Outcomes (1)

  • 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 (6)

  • Manchester-Oxford Foot Questionnaire (MOxFQ)

    6 week, 12 weeks, 1year, 2 years

  • Range of Motion measured by a goniometer (ad modum Lindsjo)

    6 week, 12 weeks, 1year, 2 years

  • Numeric Rating Scale (NRS)

    6 week, 12 weeks, 1year, 2 years

  • Euroqol questionnaire (EQ- 5D)

    6 week, 12 weeks, 1year, 2 years

  • Registrations of complications/adverse events

    0-2 years

  • +1 more secondary outcomes

Study Arms (1)

Non-operative treatment

EXPERIMENTAL

Non-operative treatment based on weightbearing radiographs

Other: Non-operative treatment

Interventions

Non-operative treatmentOTHER

Patients will be treated with a walker-orthosis for 6 weeks. Weightbearing as tolerated

Non-operative treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age
  • with pre-injury walking ability without aids

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Østfold Hospital Trust

Sarpsborg, Østfold fylke, 1714, Norway

RECRUITING

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Central Study Contacts

Marius Molund, PhD

CONTACT

0047 90093988mariusmolund@hotmail.com

Silje Karlsen

CONTACT

0047 90761773silje-karlsen@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 13, 2023

Study Start

February 28, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2032

Last Updated

August 8, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)