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IMPRESS

1.  IMPRESS

Steering Committee

2.  SOLVED

3.  rhBMP-2

4.  Femur Outcomes

5.  Damage Control

6.  Sacral Fractures

8. Scapula Fractures

Title

Intramedullary Nails versus Plate Fixation Re-Evaluation Study in Proximal Tibia Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation

Summary

Proximal tibia 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 over the other. However, no comparison between the outcomes of 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 evaluations.
With the advent of locked plating and advanced instrumentation, plating of proximal tibia fractures can now be performed without extensive incisions. This has led to improved stability with plating techniques and an increase in plate use for these injuries. Part of this trend was to avoid the previously reported incidence of malalignment of proximal tibia fractures treated with nails. However, nailing techniques have advanced substantially since those reports with the use of blocking screws, a semiexended approach, and nails that have off axis multiple point locking. Additionally, plating of patients with poor soft tissues is associated with higher wound complication rates. The ideal treatment for proximal tibia fractures is unclear with some surgeons preferring nails and others, locked plates. The proposed study will help to clarify the advantages and disadvantages using these techniques with respect to patient based, objective physical examination, and radiologic outcomes in a randomized, and generalizable way. This will aid orthopaedic surgeons in deciding the best treatment for a particular patient.

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Research Design

We propose a multicenter randomized controlled trial in which individuals sustaining a fracture of the proximal metaphysis of the tibia 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.

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Outcomes

The primary outcome: 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.

The secondary outcomes: Re-operation (secondary procedures), nonunion*, superficial infection** rates (wound only), deep infection** (bone implant interface), incidence of compartment syndrome**, malunion** (>5 degrees varus/valgus, >5 degrees anterior or posterior angulation, >10 malrotation degrees, 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 continually monitor primary and secondary outcomes as well as complications and adverse events.

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Inclusion Criteria

1. Skeletally mature

2. Extraarticular fracture of the proximal tibia extending into the metaphysis with or without intraarticular extension not requiring open reduction with complete AP and Lateral  diographs

3. Fracture requiring operative treatment amenable to both 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 proximal tibia fracture, which had undergone previous debridement and / or spanning external fixator placement elsewhere.

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Exclusion Criteria

1. Tibial shaft fracture not amenable to intramedullary nailing
2. Fracture of the proximal tibia with intraarticular extension requiring open reduction
3. Known metabolic bone disease
4. Separate displaced tibial tubercle fragment
5. Soft tissue injuries compromising treatment method with nail, plate, or both
6. Fractures with vascular injury (Gustillo Type IIIC injury) requiring repair
7. Compartment syndrome of the leg diagnosed preoperatively
8. Pathological fracture
9. Contralateral proximal tibia fractures (bilateral injury) or ipsilateral lower extremity injury that would compromise function of the knee
10. Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating
11. Symptomatic knee arthritis
12. Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures
13. Immunocompromised
14. Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injury or mentally impaired)
15. Current or impending incarceration
16. Unlikely to follow-up in surgeon's estimation

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References

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