NCT04437355

Brief Summary

Patients who underwent operative treatment of an ankle fracture with or without following removal of the osteosynthetic material are examined by a specific ankle provocation test, a questionnaire and X-Rays to evaluate the clinical, functional and radiological outcome compared to a healthy control group

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

3.5 years

First QC Date

January 7, 2020

Last Update Submit

October 25, 2022

Conditions

Ankle Fracture, TrimalleolarAnkle Fracture - Lateral MalleolusAnkle Fracture, Bimalleolar

Outcome Measures

Primary Outcomes (2)

  • Functional outcome

    This outcome will be compared with a group of adults matching in terms of gender and age. Measured by: \- a specific ankle provocation test: Multiple sport test measuring possible movement of the ankle and tolerating stress simulating in sportive movement such as weight bearing, leg press tests etc. The specific provocation test does not have a specific name, because it is self made.

    at least two year after surgery or one year after removal of the osteosynthetic material

  • Functional outcome

    This outcome will be compared with a group of adults matching in terms of gender and age. Measured by: \- three questionnaires (quality of life, possible movement, restrictions in daily life etc.)

    24 months after initial operation

Secondary Outcomes (3)

  • Clinical outcome 1

    24 months after initial operation

  • Clinical outcome 2

    24 months after initial operation

  • Clinical outcome 3

    24 months after initial operation

Other Outcomes (1)

  • Specific ankle provocation test

    24 months after initial operation

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Young and healthy Group of People (18-50 years) without any pathology of the lower limb

Diagnostic Test: Specific provocation test

Ankle Fracture Type Weber B

ACTIVE COMPARATOR

Young and healthy patients with an operative treated fracture of the ankle (type Weber B)

Diagnostic Test: Specific provocation test

Ankle Fracture Weber C and complex

ACTIVE COMPARATOR

Young and healthy patients with an operative treated fracture of the ankle (type Weber C or complex fracture)

Diagnostic Test: Specific provocation test

Interventions

Specific provocation testDIAGNOSTIC_TEST

To compare the results the investigators invite a healthy control group matching in age and gender with the intervention cohort. The control group is informed about the study and asked to participate in the outpatient clinic. In case of informed consent, the participants are invited to the study site. The participants undergo the same provocation test of the ankle, and are asked to complete the specific provocation test. In case of substantial underachievement in the provocation test (\<60% of maximum) an X-Ray of both ankles in a.p. and lateral projection is performed. The aim is to radiologically analyse the ankles, and to rule out any morphological reasons for the above mentioned underperformance.

Ankle Fracture Type Weber BAnkle Fracture Weber C and complexControl Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age older than 18 and younger than 51 years
  • Operative treatment of an ankle fracture
  • Time operation to follow up: at least 2 years
  • Time removal of osteosynthetic material to follow up: at least 1 year
  • Time operative treatment to removal of the osteosynthetic material: at least 9 months
  • Informed Consent as documented by signature (Appendix: Informed Consent Form)

You may not qualify if:

  • Other pathologies of the lower limb of the affected and/or non-affected side (fractures, pre-existing arthrosis or operative treatment of the affected and/or non-affected limb)
  • Pre-existing vascular (peripheral arterial disease, diabetes) or neurological diseases of the lower extremities
  • Women who are pregnant
  • Prevalence of an infection of the implanted osteosynthetic material

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spital Limmattal

Schlieren, Canton of Zurich, 8952, Switzerland

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Officials

  • Urs Zingg

    Spital Limmattal Schlieren

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of surgery

Study Record Dates

First Submitted

January 7, 2020

First Posted

June 18, 2020

Study Start

July 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)