Zimmer® MotionLoc® in Distal Tibia Fractures

Primary Endpoint:

• Radiographic & clinical fracture healing at 3 months post-surgery.

Secondary Endpoints:

• Complications
• Radiologic & clinical fracture healing at 6 weeks, 3, 6, and 12 months post-surgery.
• Callus size & distribution at 6 weeks, 3, 6, and 12 months post-surgery.

Radiologic fracture healing is defined as bridging of three of the four cortices as seen on x-ray/CT. Clinical healing will be assessed using the Function Index for Trauma (FIX-IT). The FIX-IT instrument quantifies clinical healing by assessing weight-bearing and fracture site pain on an ordinal scale. It has been initially validated in patients with tibia and femur fractures.

Callus size of the anterior, posterior, and medial aspect will be assessed for each time point using a validated and published computational method.

Inclusion criteria

• With or without fibula fracture involvement (treated or not treated by osteosynthesis)
• Close or open fractures Gustilo type I
• Unilateral or bilateral fractures
• Patients who are capable of understanding the doctor's explanations, following his instructions and are able to participate in the follow-up program.
• Patients who give written consent to take part in the study by signing the "Patient Consent Form".

Exclusion criteria

• Delay of surgery for more than two weeks.
• Open fractures Gustilo type II & III
• History of infection of the affected extremity
• Non-ambulatory patients
• Planned fixation strategy includes interfragmentary lag screw fixation of non-articular fractures.
• Addition of bone graft, bone graft substitute or bone morphogenetic protein (BMP).
• Immobilization with plaster.
• Likely problems with maintaining follow-up program (e.g. patients with no fixed address, plans to move during course of study)
• Not expected to survive the duration of follow-up program.
• Patients known to be pregnant or breastfeeding.
• Patients who are unwilling or unable to give consent.