NCT03944590

Brief Summary

This cohort study investigates radiological and clinical outcome after screw osteosynthesis of radial head fractures with associated injuries (such as rupture of the interosseous membrane and collateral ligaments). Interpretation of radiographs 3 and 9 months post- surgery and patient surveys will be analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

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

August 8, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

May 6, 2019

Last Update Submit

March 11, 2020

Conditions

Radial Head Fractures

Keywords

screw osteosynthesisrupture of the interosseous membranecollateral ligaments

Outcome Measures

Primary Outcomes (1)

  • Change in status of bone healing assessed by radiographs

    Analysis of radiographs with regard to bone healing (cortical bone, dislocation of fracture and dislocation of screws)

    3 months and 9 months post surgery

Secondary Outcomes (4)

  • elbow status assessed by Mayo Elbow Score (MEPS)

    single time point, assessment 2 to 7 years after surgery

  • Patient reported outcome of elbow surgery assessed by Oxford Elbow Score (OES)

    single time point, assessment 2 to 7 years after surgery

  • Patient reported outcome assessed by Quick Dash

    single time point, assessment 2 to 7 years after surgery

  • Assessment on employment

    single time point, assessment 2 to 7 years after surgery

Interventions

patient surveyOTHER

patient survey on clinical outcome after screw osteosynthesis of radial head fractures

analysis of radiographsOTHER

analysis of radiographs on radiological outcome after screw osteosynthesis of radial head fractures

Eligibility Criteria

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

patients undergoing screw osteosynthesis of radial head fractures at Universitätsspital Basel between June 2010 until June 2016

You may qualify if:

  • screw osteosynthesis of radial head fractures

You may not qualify if:

  • unable to give consent
  • dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Radial Head and Neck Fractures

Condition Hierarchy (Ancestors)

Elbow FracturesElbow InjuriesArm InjuriesWounds and InjuriesRadius FracturesForearm InjuriesFractures, Bone

Study Officials

  • Daniel Rikli, Prof. Dr.

    Department of Orthopaedics and Traumatology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 9, 2019

Study Start

August 8, 2018

Primary Completion

August 6, 2019

Study Completion

February 29, 2020

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

CH(1)