Distal Femur Fracture Nonunion - Statistical Analysis Plan | NCT05163795

Studies
Distal Femur Fracture Nonunion - Statistical Analysis Plan

NCT05163795

Sponsor

Töölö Hospital

Status

Completed

Last Update Posted

May 9, 2024Actual

Enrollment

299Actual

Phase

Not provided

Conditions

Femur Distal Fracture
Nonunion of Fracture

Interventions

Lateral locking plate

Countries

Finland

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2019Actual

Primary Completion Date

Aug 15, 2023Actual

Completion Date

Aug 15, 2023Actual

First Submitted Date

Dec 15, 2021

First Submission Date that Met QC Criteria

Dec 15, 2021

First Posted Date

Dec 20, 2021Actual

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

May 7, 2024

Last Update Posted Date

May 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

Here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures.

Detailed Description

See attached PDF.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

299Actual

Name	Type	Description	Arm Group Labels	Other Names
Lateral locking plate	Procedure	Plating of the distal femur fracture with lateral locking plate.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reoperation	Reoperation due to fracture nonunion	Within 36 months after the initial trauma

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 16 years
AO/OTA type A or C distal femur fracture
Fracture located on the metaphyseal area of the distal femur (square method)
Operative treatment in the Helsinki University Hospital with a distal femur anatomic lateral locking plate
Operative treatment within 1 month after trauma
Operative treatment between years 2009 and 2018

Exclusion Criteria:

Stress fracture
Pathological fracture
An epicondylar or subchondral fracture
A ligament sprain in distal femur
Treatment with a double-plating method or with both plate and nail
Non-surgical treatment and patients who died before the treatment
Treatment with an unconventional plate (other than distal femur plate)
Patients whose follow-up criteria not fulfilled

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

110 Years

Standard Ages

ChildAdultOlder Adult

Study Population

This study is a retrospective cohort study conducted in level 1 trauma center at the Helsinki University Hospital with a catchment population of around one million for these fractures. All patients with a distal femur fracture treated at our institution between 2009 and 2018 were screened for eligibility.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan Lindahl, MD, PhD	Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital		Helsinki		00029	Finland

Label	URL
Publication	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Dec 16, 2021	Dec 17, 2021	SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000092524	Femoral Fractures, Distal
D005599	Fractures, Ununited

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided