Overview

This trial is active, not recruiting.

Condition femoral fractures
Treatments reamed, interlocking intramedullary nail, locking periarticular plate
Sponsor Boston Medical Center
Start date February 2007
End date December 2014
Trial size 160 participants
Trial identifier NCT00429663, H-25934

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Randomized treatment
reamed, interlocking intramedullary nail
Standard of care device for femur fracture repair
(Other)
Randomized Treatment
locking periarticular plate
Standard of care device for femur fractures

Primary Outcomes

Measure
SF-12v2
time frame: Up to 24 months post-op
EQ-5D
time frame: Up to 24 months post-op
SMFA
time frame: Up to 24 months post-op
Knee Society Score
time frame: Up to 24 months post op
Clinical Assessment
time frame: Up to 24 months post-op

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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)
Principal investigator Paul Tornetta, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Boston Medical Center.