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SOLVED

1.  IMPRESS

Status

Steering Committee

Study Materials Jump To

2.  SOLVED

Closed to Enrollment

Mo Bhandari

Protocol Summary

3.  rhBMP-2

23 Centers Phil Kregor Forms Research Design

4.  Femur Outcomes

  Bob Ostrum Visit Windows Outcomes

5.  Damage Control

Study Registration Bill Ricci Amendments Inclusion Criteria

6.  Sacral Fractures

NCT00429663 Paul Tornetta DSMB Report - Jan 11 Exclusion Criteria

7.  Ankle Plating

Phil Wolinsky   References
8. Scapula Fractures

Title

A Study of Locked Plates Versus Intramedullary Nails in Distal Femur Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation

Summary

Distal femur fractures are unstable injuries that are generally treated with surgical fixation to maintain alignment of the extremity during the healing process. The two most common methods of fixation are intramedullary nailing and plate fixation. Both techniques are considered the standard of care. Each method has risks associated with it, and some surgeons prefer one method over the other. However, no comparison between the two techniques has been performed. We plan a randomized trial comparing these two fixation methods using standardized validated general and disease specific measures as well as standard radiographic and clinical outcomes.

With the advent of locked plating and advanced instrumentation, plating of distal femur fractures can now be performed without extensive incisions. This has created a shift in procedures done for distal femur fractures that extend into the metaphysis and epiphysis. While good results have been reported for locked plating, it is a different form of fixation than intramedullary nailing. While both techniques are considered standard, no comparison of the two has been performed. Advantages and disadvantages of each technique may be different, leading to better results or alignment using one versus the other. We seek to elucidate the respective advantages and disadvantages of each technique in a randomized trial. Patient based, radiologic, and objective physical examination outcomes will be collected and compared. These will demonstrate sameness (well powered) or differences between the treatments and help orthopaedic surgeons decide on the ultimate treatment for patients with this injury.

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Research Design:

We propose 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. We will monitor critical aspects of pre-operative and post-operative care and provide immediate feedback to the participating surgeons when any important deviation from the following protocol occurs.

Outcomes

Primary outcomes: General outcome will be determined by both the SF-12v2 and EuroQol 5D. Disease-specific outcomes will be assessed by the Short Musculoskeletal Functional Assessment measure (SMFA) and a knee score.

Secondary outcomes: Rate of re-operation (secondary procedures), nonunion*, superficial infection rates**, deep infection**, malunion** (>5 degrees varus/valgus, >10 malrotation degrees, 1 cm translation in frontal or sagittal plane, and >1cm shortening) and knee range of motion.

The treatment provided will be obvious because of differences in surgical incisions and radiographic appearance of the injured limbs; therefore it will not be possible to blind all the patients, surgeons, and some evaluators to treatment allocation. When possible, outcome assessment will be done by independent, blinded parties. We will follow and monitor primary and secondary outcomes, complications, and adverse events continually.

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Inclusion Criteria

1. Skeletally mature

2. Fracture of the metaphyseal distal femur with or without intra-articular extension

3. Fracture requiring operative treatment amenable to either IM nail or plate

4. Surgeon agreed to randomize patient

5. Informed consent obtained

6. Patient is English speaking

Patients may have undergone previous surgical interventions either for placement of a spanning external fixator and/or debridement of open fracture wounds. This may have been done at the eventual treating institution or not. That is, the patient could represent a referral of a distal femur fracture, which had undergone previous debridement and spanning external fixator placement.
 

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Exclusion Criteria

1. Fracture of the metaphyseal distal femur with intraarticular comminution
2. Fracture with vascular injury (Gustillo Type IIIC injury) requiring repair
3. Pathological fracture
4. Known metabolic bone disease
5. Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating
6. Symptomatic knee arthritis
7. Soft tissue injuries compromising either treatment method with nail or plate
8. Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fracture
9. Contralateral distal femur fracture (bilateral injury) or lower extremity injury that would compromise outcome assessment
10. Immunocompromised
12. Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired)
13. Current or impending incarceration
14. Unlikely to follow-up in surgeon’s estimation
 

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