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

Femoral Fractures Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00429663
• Other study ID #: H-25934
• Status: Active, not recruiting
• Phase: N/A
• First received: January 30, 2007
• Last updated: June 14, 2016
• Start date: February 2007
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone

Intervention

Device:
• reamed, interlocking intramedullary nail
Standard of care device for femur fracture repair
• locking periarticular plate
Standard of care device for femur fractures

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Boston Medical Center	Boston	Massachusetts
United States	Cooper University Hospital	Camden	New Jersey
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Orthopaedic Specialty Associates Fort Worth	Fort Worth	Texas
United States	Orthopaedic Associates of Michigan	Grand Rapids	Michigan
United States	Indiana University	Indianapolis	Indiana
United States	Campbell Foundation	Memphis	Tennessee
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	New York Hospital for Joint Diseases	New York	New York
United States	University of Oklahoma/ Health Science	Oklahoma City	Oklahoma
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health and Sciences University	Portland	Oregon
United States	St. Mary's Hospital - Mayo Clinic	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	University of California - Davis	Sacramento	California
United States	Harborview Medical Center	Seattle	Washington
United States	Barnes Hospital	St. Louis	Missouri
United States	St. Louis University Hospital	St. Louis	Missouri
United States	Tampa General Hospital	Tampa	Florida
United States	UMass Memorial Medical Center	Worchester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF-12v2		Up to 24 months post-op	No
Primary	EQ-5D		Up to 24 months post-op	No
Primary	SMFA		Up to 24 months post-op	No
Primary	Knee Society Score		Up to 24 months post op	No
Primary	Clinical Assessment		Up to 24 months post-op	No
Secondary	Re-operation (secondary procedures)		Up to 24 months post-op	Yes
Secondary	nonunion		Until radiographically healed	Yes
Secondary	superficial infection rates (wound only)		Up to 24 months post-op	Yes
Secondary	deep infection (bone implant interface)		Up to 24 months post-op	Yes
Secondary	compartment syndrome		Up to 24 months post-op	Yes
Secondary	malunion (>5 degrees varus/valgus)		Up until radiographically healed	Yes
Secondary	>5 degrees anterior or posterior angulation		Up until radiographically healed	Yes
Secondary	>10 malrotation degrees, and >1cm shortening)		Up until radiographically healed	Yes
Secondary	knee range of motion		Up to 24 months post-op	Yes