Clinical trial NCT00429663: 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
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Fractures
Keywords: distal femur
femur fracture
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2007-02-01
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: EQ-5D
timeFrame: 3 months, 6 months, 12 months
measure: Short Musculoskeletal Functional Assessment (SMFA) Score
timeFrame: 3 months, 6 months, 12 months
measure: EQ Index
timeFrame: 3 months, 6 months, 12 months
measure: SMFA - Bother Index
timeFrame: 3 months, 6 months, 12 months
Secondary outcomes:
measure: Valgus of Over 5 Degrees
timeFrame: 12 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California - Davis
state: California
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Worchester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Rochester
country: United States
facility: St. Mary's Hospital - Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Barnes Hospital
state: Missouri
city: St. Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: New York
country: United States
facility: New York Hospital for Joint Diseases
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma/ Health Science
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: Campbell Foundation
state: Tennessee
city: Fort Worth
country: United States
facility: Orthopaedic Specialty Associates Fort Worth
state: Texas
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: Boston University
name: Paul Tornetta, M.D.
role: PRINCIPAL_INVESTIGATOR
References: