Solved and Impress

Investigator: Saam Morshed, MD, MPH, PhD
Sponsor: Boston Medical Center Corporation

Location(s): United States


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

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.


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

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.   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.