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A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures

Primary Purpose

Femoral Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
reamed, interlocking intramedullary nail
locking periarticular plate
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Fractures focused on measuring distal femur, femur fracture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Skeletally mature
  • Fracture of the metaphyseal distal femur with or without intra-articular extension and with or without a TKA
  • Fracture requiring operative treatment amenable to either IM nail or plate
  • Informed consent obtained
  • Patient is English speaking

Exclusion Criteria:

  • Fracture of the metaphyseal distal femur with intra-articular communition,
  • Fracture with vascular injury (Gustillo Type IIIC injury) requiring repair,
  • Pathological fracture,
  • Known metabolic bone disease,
  • Contralateral distal femur fractures (bilateral injury) or ipsilateral lower extremity injury that would compromise function of the knee
  • Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating
  • Symptomatic knee arthritis
  • Soft tissue injuries compromising either treatment method with nail or plate
  • Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures
  • Immunocompromised
  • Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired)
  • Current or impending incarceration
  • Unlikely to follow-up in surgeon's estimation

Sites / Locations

  • University of California - Davis
  • Tampa General Hospital
  • Indiana University
  • University of Maryland Medical Center
  • Boston Medical Center
  • UMass Memorial Medical Center
  • University of Michigan Hospital
  • Orthopaedic Associates of Michigan
  • Hennepin County Medical Center
  • St. Mary's Hospital - Mayo Clinic
  • Barnes Hospital
  • St. Louis University Hospital
  • Cooper University Hospital
  • New York Hospital for Joint Diseases
  • University of Rochester Medical Center
  • Ohio State University Medical Center
  • University of Oklahoma/ Health Science
  • Oregon Health and Sciences University
  • University of Pittsburgh
  • Campbell Foundation
  • Orthopaedic Specialty Associates Fort Worth
  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

IM Nails

Plate Fixation

Arm Description

Reamed, Interlocking Intramedullary Nail - Randomized treatment

Locking Periarticular Plate - Randomized Treatment

Outcomes

Primary Outcome Measures

EQ-5D
EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best.
Short Musculoskeletal Functional Assessment (SMFA) Score
The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.
EQ Index
EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best.
SMFA - Bother Index
The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.

Secondary Outcome Measures

Valgus of Over 5 Degrees
Valgus is a deformity involving oblique displacement of part of a limb away from the midline.

Full Information

First Posted
January 30, 2007
Last Updated
April 5, 2017
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00429663
Brief Title
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures
Official Title
Study of Locked Plates Versus Intramedullary Nails in Distal Femur Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (S.O.L.V.E.D)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study looks at two (2) types of surgical treatments and hopes to answer the question, "which is the best way to surgically treat a distal femur fracture?" Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.
Detailed Description
The study is a randomized controlled multicenter trial in which individuals sustaining a fracture of the supracondylar (metaphyseal) region of the distal femur will be operatively managed by one of two strategies. The first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fractures
Keywords
distal femur, femur fracture

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
IM Nails
Arm Type
Other
Arm Description
Reamed, Interlocking Intramedullary Nail - Randomized treatment
Arm Title
Plate Fixation
Arm Type
Other
Arm Description
Locking Periarticular Plate - Randomized Treatment
Intervention Type
Device
Intervention Name(s)
reamed, interlocking intramedullary nail
Intervention Description
Standard of care device for femur fracture repair
Intervention Type
Device
Intervention Name(s)
locking periarticular plate
Intervention Description
Standard of care device for femur fractures
Primary Outcome Measure Information:
Title
EQ-5D
Description
EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best.
Time Frame
3 months, 6 months, 12 months
Title
Short Musculoskeletal Functional Assessment (SMFA) Score
Description
The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.
Time Frame
3 months, 6 months, 12 months
Title
EQ Index
Description
EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best.
Time Frame
3 months, 6 months, 12 months
Title
SMFA - Bother Index
Description
The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.
Time Frame
3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Valgus of Over 5 Degrees
Description
Valgus is a deformity involving oblique displacement of part of a limb away from the midline.
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Skeletally mature Fracture of the metaphyseal distal femur with or without intra-articular extension and with or without a TKA Fracture requiring operative treatment amenable to either IM nail or plate Informed consent obtained Patient is English speaking Exclusion Criteria: Fracture of the metaphyseal distal femur with intra-articular communition, Fracture with vascular injury (Gustillo Type IIIC injury) requiring repair, Pathological fracture, Known metabolic bone disease, Contralateral distal femur fractures (bilateral injury) or ipsilateral lower extremity injury that would compromise function of the knee Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating Symptomatic knee arthritis Soft tissue injuries compromising either treatment method with nail or plate Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures Immunocompromised Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired) Current or impending incarceration Unlikely to follow-up in surgeon's estimation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Tornetta, M.D.
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California - Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worchester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Orthopaedic Associates of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
St. Mary's Hospital - Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Barnes Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis University Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
New York Hospital for Joint Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma/ Health Science
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Oregon Health and Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Campbell Foundation
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Orthopaedic Specialty Associates Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures

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