Home | About Us | Contact Us | Randomizer Login

Femoral Shaft Outcomes

1.  IMPRESS

Steering Committee

2.  SOLVED

3.  rhBMP-2

5.  Damage Control

6.  Sacral Fractures

7.  Ankle Plating

8. Scapula Fractures

Title

Functional Outcomes of Femoral Shaft Fractures: A Multicenter, Prospective Study on Surgery Timing and the Effect on Local and Systemic Complications

Summary

The primary aim of this investigation is the evaluation of functional outcomes of patients with diaphyseal femur fractures treated with intramedullary nails, documenting these patient based outcomes at various time points (3, 6, 12, 24 months). Secondary aims include subgroup analyses of multitrauma patients with diaphyseal femur fractures versus those patients with isolated femoral shaft fractures. The null hypothesis for this subgroup analysis posits that no significant differences will be identified in outcomes or in the time curve of the recovery. Our additional secondary aim is the comparison of the three types of intramedullary nailing techniques commonly utilized for the surgical management of these diaphyseal femur fractures. Anterograde piriformis, anterograde trochanteric, and retrograde starting points are all commonly employed by orthopaedic surgeons managing these patients. The null hypothesis for this subgroup analysis proposes that patient based outcome and time curve of the recovery are both independent of the nail technique employed.

[return to top]

Research Design

The study will be set up as a longitudinal cohort study in 390 patients with femoral shaft fractures with a priori groups that will be compared. The primary outcome is patient based recovery over time to be evaluated using multiple validated outcome tools for physical function, psychological well being, and return to activities. The secondary analysis will be a comparison of patients with isolated injuries versus those with multiple injuries.

 
Based on the outcomes being investigated, a randomized trial is not necessary or possible. The effect of other variables will be evaluated by a regression analysis. This will include the effect of education, work status, smoking, technique of nailing, alignment, motion, pain, etc on outcome.

[return to top]

Inclusion Criteria
 

1.  18-65 years of age
2.  Fracture of the femoral diaphysis amenable to intramedullary nail fixation
3.  Surgeon agreed to randomize patient
4.  Informed consent obtained
5.  Patient is English speaking

[return to top]
 

Exclusion Criteria

1.  Age < 18 or > 65
2.  Ipsilateral proximal femur fracture (femoral neck, intertrochanteric, subtrochanteric)
3.  Ipsilateral distal femur metaphyseal fracture with or without intercondylar extension
4.  Fracture with vascular injury (Gustillo Type IIIC injury) requiring repair
5.  Pathological fracture
6.  Known metabolic bone disease
7.  Multiple traumatic injuries of the ipsilateral lower extremity (hip, femur, tibia) that would compromise outcome assessment
8.  Periprosthetic fracture
9.  Retained hardware or existing deformity in the affected limb that would complicate IM nailing
10.  Symptomatic hip and/or knee arthritis
11.  Soft tissue injuries compromising treatment method with nail
12.  Initial surgical delay greater than 2 weeks for closed fractures or 24 hours for open fractures
13.  Contralateral femur fracture (bilateral injury) or lower extremity injury that would compromise outcome assessment
14.  Immunocompromise
15.  Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired)
16.  Current or impending incarceration
17.  Unlikely or unwilling to follow-up
18.  Nonoperative femoral shaft fracture

[return to top]