NCT02717546

Zimmer® MotionLoc® in Distal Tibia Fractures

Zimmer® MotionLoc® in Distal Tibia Fractures: An Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this observational prospective study is to systematically document the clinical outcomes of Zimmer MotionLoc Screws for Periarticular Locking Plate System applied to distal tibia fracture treatment and confirm safety and performance of the screws.

Detailed description

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.

Conditions

• Distal Tibia Fractures

Interventions

Type	Name	Description
DEVICE	Zimmer MotionLoc Screw	Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.

Timeline

• Start date: 2016-02-01
• Primary completion: 2019-12-05
• Completion: 2020-01-15
• First posted: 2016-03-23
• Last updated: 2021-08-04
• Results posted: 2021-08-04

Locations

7 sites across 5 countries: United States, Australia, Italy, South Korea, United Kingdom