Distal Femur Fracture Nonunion - Statistical Analysis Plan

• Sponsor: Töölö Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05163795
• Collaborator: (none)
• Enrollment: 299
• Location: 1
• Anticipated Duration (Months): 42.7
• Patients Per Site Per Month: 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Femur Distal Fracture; Nonunion of Fracture	Procedure: Lateral locking plate

Detailed Description

See attached PDF.

Study Design

• Study Type: Observational
• Actual Enrollment: 299 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Prediction of Fracture Nonunion Leading to Secondary Surgery in Patients With Distal Femur Fractures - Statistical Analysis Plan
• Actual Study Start Date: May 15, 2019
• Anticipated Primary Completion Date: May 31, 2022
• Anticipated Study Completion Date: Dec 6, 2022

Outcome Measures

Primary Outcome Measures

1. Reoperation [Within 36 months after the initial trauma]

   Reoperation due to fracture nonunion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital	Helsinki		Finland	00029

Sponsors and Collaborators

• Töölö Hospital

Investigators

• Study Director: Jan Lindahl, MD, PhD, Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland

Study Documents (Full-Text)

• Statistical Analysis Plan - Dec 16, 2021

More Information

Publications

None provided.

• Responsible Party: Heini Sainio, Principal Investigator, Resident in Orthopedics and Traumatology, Töölö Hospital
• ClinicalTrials.gov Identifier: NCT05163795
• Other Study ID Numbers: Distal Femur Fractures - SAP
• First Posted: Dec 20, 2021
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Heini Sainio, Principal Investigator, Resident in Orthopedics and Traumatology, Töölö Hospital: Prediction; Distal femur fracture; Nonunion; Statistical analysis plan
• Additional relevant MeSH terms: Fractures, Bone; Femoral Fractures; Fractures, Ununited

Study Results

No Results Posted as of Apr 27, 2022