NCT04033848

Brief Summary

The aim of this study is to evaluate the intraarticular lesions, to identify fractures specifically at risk for these, and to assess the results following arthroscopically assisted open reduction and internal fixation of complex ankle fractures prospectively.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

7 years

First QC Date

July 19, 2019

Last Update Submit

July 23, 2019

Conditions

Ankle Fractures

Keywords

ArthroscopyAnkle FracturePatient rated outcome

Outcome Measures

Primary Outcomes (1)

  • OMAS

    Olerud and Molander Ankle Score; Validated PROM; Range 0-100

    Through study completion, an average of 1 year

Secondary Outcomes (8)

  • ICRS: Clinical Cartilage Injury Evaluation System

    IntraOP

  • FAAM

    Through study completion, an average of 1 year

  • AOFAS

    Through study completion, an average of 1 year

  • FAOS

    Through study completion, an average of 1 year

  • TAS

    Through study completion, an average of 1 year

  • +3 more secondary outcomes

Interventions

Arthroscopic assisted ankle fracture treatmentPROCEDURE

Any complex ankle fracture, as discriped above, will be treated arthroscopically and will be prospectively followed-up using well validated PROMs

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient are being recruted from the investigator's ER or foot and ankle outpatient deparment

You may qualify if:

  • Unimalleolar fracture + ligamentous injury
  • Bi- or trimalleolar fracture ± ligamentous injury
  • \> 17 years
  • Date of injury less than 15 days
  • Written informed consent

You may not qualify if:

  • Isolated unimalleolar fracture
  • Pilon fracture
  • Open fracture
  • Mental illness, incompliance, pregnancy
  • Multiple injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Trauma Surgery, Medical University of Munich

Munich, 80336, Germany

RECRUITING

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Officials

  • Wolfgang Böcker, MD

    LMU Munich

    STUDY CHAIR

Central Study Contacts

Sebastian F Baumbach, MD

CONTACT

0049894400sebastian.baumbach@med.uni-muenchen.de

Hans Polzer, MD

CONTACT

0049894400hans.polzer@med.uni-muenchen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 26, 2019

Study Start

May 1, 2013

Primary Completion

May 1, 2020

Study Completion

May 1, 2021

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations

DE(1)