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Dual Implant Versus Single Implant Distal End of Femur

Primary Purpose

Distal Femur Fracture

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single distal femur implant
Dual distal femur implants
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Femur Fracture focused on measuring Distal Femur Fracture, Dual distal femur implants, Single distal femur implant, Mortality

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient age 60 years or greater,
  • Femur fracture distal to the femoral diaphysis,
  • Operative treatment within 72 hours of presenting to the treating hospital,
  • Patient was previously ambulatory,
  • Fracture amendable to either single or dual implant fixation,
  • Informed consent can be obtained from the patient, family member, or power of attorney.

Exclusion Criteria:

  • Associated major lower extremity fracture,
  • Ongoing infection,
  • History of metabolic bone disease (Paget's, etc),
  • Pathologic fracture,
  • Open fracture,
  • Severe cognitive impairment (Six Item Screener with 3 or more errors),
  • Stage 5 Parkinson's disease,
  • Significant femoral bone loss requiring planned staged bone grafting,
  • Vascular injury.

Sites / Locations

  • University of Utah Orthopaedic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Single distal femur implant

Dual distal femur implants

Arm Description

Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.

Dual implant constructs will either be an intramedullary nail with an additional plate and screw construct or dual (two plates in any orientation) plate and screw construct.

Outcomes

Primary Outcome Measures

Mortality
The primary outcome will be one-year mortality.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2022
Last Updated
March 13, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05292313
Brief Title
Dual Implant Versus Single Implant Distal End of Femur
Official Title
Pilot for Dual Implant Versus Single Implant Distal End of Femur (pDISIDE Femur)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators overall study objective is to determine the difference in outcomes for patients over 60 years of age with a displaced distal femur fracture treated with dual distal femur implants (dual plate or IMN/plate) vs. a single distal femur implant (plate or IMN).
Detailed Description
The incidence of distal femur fractures in elderly patients continues to increase, most recently having an incidence of 8.7/100,000/year. This trend likely accompanies the aging population and the increased rates of knee arthroplasty. While these fractures are far less common than geriatric hip fractures, distal femur fractures present similar treatment challenges. Elderly distal femur fractures tend to occur in compromised hosts with poor bone mineral density. Similar to geriatric hip fractures, care emphasizes early mobilization to avoid the complications associated recumbency, including pneumonia, pressure sores, and venous thromboembolism. These patients are often unable to mobilize with restricted weight bearing, which places significant stress on the fixation construct. As a result, elderly patients with distal femur fractures can have high rates of morbidity and mortality. Despite several prior studies reporting one year mortality greater than 20%, elderly distal femur fractures do not receive the same attention as geriatric hip fractures. These patient injuries are likely similar in terms of their age and comorbidities while having the same issues with post-operative mobility. Therefore, it makes sense that geriatric distal femur fracture patients and geriatric hip fracture patients have similar mortality rates. Investigators recently reported significantly greater in-hospital mortality in geriatric distal femur fractures as compared to geriatric hip fractures. A recent study of the US Medicare database is the largest study on geriatric distal femur fractures in the literature, and the overall mortality of 18.5% is similar to several prior studies ranging from 13-38%. Distal femur fractures have traditionally been treated with operative fixation using either a lateral plate or an intramedullary nail. Advances in plate and nail technology allow for distal femur fractures to be stabilized with minimal soft tissue dissection. While recent studies suggest that early weight bearing can be tolerated with low failure rates, many surgeons continue to institute weight-bearing restrictions for osteopenic patients treated with operative fixation. Nonunion rates for operatively treated distal femur fractures have been reported to be as high as 20% in large series, leading to additional surgery to achieve union. These limitations with operative fixation have led surgeons to investigate the utility of supplementing the fixation with additional plates and/or nails. Since many surgeons may not allow early weight bearing in osteopenic patients with operatively treated distal femur fractures, dual plating of the distal femur and locked plate/IMN combinations have become increasingly popular. Biomechanical studies have demonstrated increased torsional stiffness and axial stiffness in dual plate and plate/nail constructs as compared to single implant. A recent meta-analysis by other investigators has further demonstrated dual implants for distal femur fractures to have a low complication rate (5% nonunion) as compared to prior evidence of single implant fixation (0-25% nonunion). In the recent study, authors reported a trend toward less one year mortality in patients treated with distal femoral replacement (DFR) (13.8%) as compared to operative fixation (22.6%) despite finding similar mortality rates at 90 days post-operatively. Since the complication rate was significantly greater in the DFR cohort, this one year mortality benefit is presumably related to early patient weight bearing after DFR that may not be permitted as frequently with operative fixation. Additionally, patients with a DFR may achieve more early mobility than operatively treated patients who are permitted immediate weight bearing due to enhanced stability in the DFR construct. Using dual implants to treat distal femur fractures may allow patients to achieve early mobility and similar mortality as a DFR patients, but have fewer post-surgical complications and less cost than a DFR. The investigators overall study aim is to determine the difference in outcomes for patients over 60 years of age with a displaced distal femur fracture treated with dual distal femur implants (dual plate or IMN/plate) vs. a single distal femur implant (plate or IMN).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Femur Fracture
Keywords
Distal Femur Fracture, Dual distal femur implants, Single distal femur implant, Mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single distal femur implant
Arm Type
Other
Arm Description
Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.
Arm Title
Dual distal femur implants
Arm Type
Other
Arm Description
Dual implant constructs will either be an intramedullary nail with an additional plate and screw construct or dual (two plates in any orientation) plate and screw construct.
Intervention Type
Procedure
Intervention Name(s)
Single distal femur implant
Intervention Description
Single implant fixation
Intervention Type
Procedure
Intervention Name(s)
Dual distal femur implants
Intervention Description
Dual implant fixation
Primary Outcome Measure Information:
Title
Mortality
Description
The primary outcome will be one-year mortality.
Time Frame
1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient age 60 years or greater, Femur fracture distal to the femoral diaphysis, Operative treatment within 72 hours of presenting to the treating hospital, Patient was previously ambulatory, Fracture amendable to either single or dual implant fixation, Informed consent can be obtained from the patient, family member, or power of attorney. Exclusion Criteria: Associated major lower extremity fracture, Ongoing infection, History of metabolic bone disease (Paget's, etc), Pathologic fracture, Open fracture, Severe cognitive impairment (Six Item Screener with 3 or more errors), Stage 5 Parkinson's disease, Significant femoral bone loss requiring planned staged bone grafting, Vascular injury.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Haller, M.D.
Organizational Affiliation
University of Utah Orthopaedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Orthopaedic Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dual Implant Versus Single Implant Distal End of Femur

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