Clinical trial NCT06286670: Single Versus Dual Implant Fixation of Distal Femur Fractures
Official title: Single Implant Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures - PRORP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Articular Fractures
Keywords: Distal Femur Fracture
Distal Femur complete articular Fracture
Distal Femur extraarticular Fracture
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-02-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: adult patients with extra-articular or complete articular distal femur fractures that will be operatively treated recruited from one of the participating sites during the index hospitalization
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.

Detailed description: Fractures of the distal femur are severe and common injuries sustained by Wounded Warriors in combat. Despite advances in implant technology, these injuries continue to have an unacceptably high rate of nonunion (failure to heal) of approximately 20%. This adverse outcome requires additional surgery to achieve fracture healing, which prolongs recovery and further delays return to duty often beyond one year after injury. The goal of this study is to investigate a potential treatment for distal femur fractures that has the potential to improve the likelihood of fracture healing and accelerate return of patient function during the healing process.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Surgically treated displaced distal femur extra articular or complete articular fractures

Exclusion Criteria:

* Patients with injury features that preclude treatment with 2 implants
* Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
* Body Mass Index (BMI) \> 40
* Injury due to ground level fall
* Patient that speaks neither English or Spanish
* Patients with multisystem injuries that could preclude return to work
* \< 18 years of age
* Prisoner

Primary outcomes:
measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
timeFrame: Week 6
measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
timeFrame: Month 3
measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
timeFrame: Month 6
measure: Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
timeFrame: Month 12
Secondary outcomes:
measure: Number of Unions
timeFrame: 6-week, 3, 6, 12 months
measure: Number of Resource Utilizations
timeFrame: 6-week, 3, 6, 12 month
measure: Number of Reoperations
timeFrame: 6-week, 3, 6, 12 months
measure: Number of Complications
timeFrame: 6-week, 3, 6, 12 months
measure: Time to Walking Without an Assistive Device
timeFrame: 6-week, 3, 6, 12 months
measure: Prescribed Weight Bearing Status
timeFrame: 6-week, 3, 6, 12 months
measure: Fear of Movement - Change in Tampa Scale for Kinesiophobia (TSK) Scores
timeFrame: 6-week, 3, 6, 12 months
measure: Health Related Quality of Life - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Scores
timeFrame: 6-week, 3, 6, 12 months
measure: Global Health Status - Change in Veterans RAND 12 Item Health Survey (VR12) Scores
timeFrame: 6-week, 3, 6, 12 months
measure: Change in the Work Productivity and Activity Impairment Questionnaire Scores
timeFrame: 6-week, 3, 6, 12 months
measure: Change in Numeric Pain Rating
timeFrame: 6-week, 3, 6, 12 months
measure: Change in Pain Inventory (BPI)
timeFrame: 6-week, 3, 6, 12 months
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Subscale--Pain Interference
timeFrame: 6-week, 3, 6, 12 months
measure: Presence of Post-Traumatic Arthritis (PTOA) - Kellgren Lawrence (KL) classification
timeFrame: 1 year
measure: Presence of Post-Traumatic Arthritis (PTOA) - Paley Grading System (PGS
timeFrame: 1 year
measure: Isokinetic Knee Flexion/Extension Strength Testing
timeFrame: Up to Year 1
measure: Counter-Movement Jump measurement
timeFrame: Up to Year 1
measure: Single Leg Static and Dynamic Postural Stability Index
timeFrame: Up to Year 1
measure: Triple Hop Performance Assessment
timeFrame: Up to Year 1
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida Gainesville
state: Florida
city: Temple Terrace
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University, Grady Memorial Research Hospital
state: Georgia
city: Macon
country: United States
facility: Atrium Health Navicent
state: Georgia
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health Carolinas Medical Center
state: North Carolina
city: Concord
country: United States
facility: Atrium Health Cabarrus
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Hershey
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health- Upstate
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Fairfax
country: United States
facility: Inova
state: Virginia
city: Winchester
country: United States
facility: Valley Health
state: Virginia
Study officials:
affiliation: Wake Forest University Health Sciences
name: Laurence Kempton, MD
role: PRINCIPAL_INVESTIGATOR
References: