Zimmer® MotionLoc® in Distal Tibia Fractures

Completed

Conditions studied: Distal Tibia Fractures

In brief

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.

Key facts

Study ID

NCT02717546

Run by

Zimmer Biomet

People needed

32

Starts

2016-02-01

Expected to finish

2020-01-15

Last updated by the study team

2021-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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".

You may not qualify if…

• 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.

Where it is running

• Springfield Clinic — Springfield, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Donald B. Slocum Research and Education Foundation — Eugene, Oregon, United States
• Mackay Specialist Day Hospital — Mount Pleasant, Australia
• Azienda Ospedaliera Universitaria Senese — Siena, Italy
• Korea University Anam Hospital — Seoul, South Korea
• The Dudley Group NHS Foundation Trust — Dudley, West Midlands, United Kingdom

Full record on ClinicalTrials.gov

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