A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures - Full Text View

Sponsored by:	Boston Medical Center
Information provided by:	Boston Medical Center
ClinicalTrials.gov Identifier:	NCT00429663

Purpose

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.

Condition	Intervention
Femoral Fractures	Device: reamed, interlocking intramedullary nail Device: locking periarticular plate

MedlinePlus related topics: Fractures Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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)

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:

SF-12v2 [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: No ]
EQ-5D [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: No ]
SMFA [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: No ]
Knee Society Score [ Time Frame: Up to 24 months post op ] [ Designated as safety issue: No ]
Clinical Assessment [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Re-operation (secondary procedures) [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: Yes ]
nonunion [ Time Frame: Until radiographically healed ] [ Designated as safety issue: Yes ]
superficial infection rates (wound only) [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: Yes ]
deep infection (bone implant interface) [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: Yes ]
compartment syndrome [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: Yes ]
malunion (>5 degrees varus/valgus) [ Time Frame: Up until radiographically healed ] [ Designated as safety issue: Yes ]
>5 degrees anterior or posterior angulation [ Time Frame: Up until radiographically healed ] [ Designated as safety issue: Yes ]
>10 malrotation degrees, and >1cm shortening) [ Time Frame: Up until radiographically healed ] [ Designated as safety issue: Yes ]
knee range of motion [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	February 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Randomized Arm Randomized treatment	Device: reamed, interlocking intramedullary nail Standard of care device for femur fracture repair Device: locking periarticular plate Standard of care device for femur fractures

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Skeletally mature
Fracture of the metaphyseal distal femur with or without intra-articular extension
Fracture requiring operative treatment amenable to either IM nail or plate
Closed or open fractures (Tscherne Grade 0-3, Gustillo Type I-IIIb)
Unilateral or bilateral femur fractures
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,
Multiple traumatic injuries of the ipsilateral lower extremity (hip femur tibia),
Perioprosthetic fracture
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429663

Contacts

Contact: Mark Zocchi

617-414-5793

mark.zocchi@bmc.org

Show 22 Study Locations

Sponsors and Collaborators

Boston Medical Center

Investigators

Principal Investigator:

Paul Tornetta, M.D.

Boston University

More Information

No publications provided

Responsible Party:	Boston University / Boston Medical Center ( Paul Tornetta, III, MD )
Study ID Numbers:	H-25934
Study First Received:	January 30, 2007
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00429663 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Medical Center:

distal femur
femur fracture

Study placed in the following topic categories:

Femoral Fractures
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

Additional relevant MeSH terms:

Femoral Fractures
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

ClinicalTrials.gov processed this record on May 07, 2009