Zimmer MotionLoc in Distal Tibia Fractures: An Observational Study
Research type
Research Study
Full title
Zimmer MotionLoc in Distal Tibia Fractures: An Observational Study
IRAS ID
183414
Contact name
Patric Sommer
Contact email
Sponsor organisation
Zimmer GmbH
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
The purpose of this observational prospective study is to systematically document the clinical outcome of the commercially available Zimmer MotionLoc Screws for Periarticular Locking Plate System applied in distal tibia fracture treatment and confirm safety and performance. The study is designed as a multicenter prospective observational study. Primary outcome will be clinical & radiological fracture healing at three months post-surgery. The study population consists of a total of 40 patients with distal tibia fractures who will be enrolled at about 8 sites (5 patients per site). Follow-up evaluations will be performed at 6 weeks, 3 months, 6 months and 12 months post-surgery. Standard anteroposterior (x-rays taken from front to back (AP)) and lateral x-rays (x-rays taken from the side) of the affected limb will be obtained at each follow-up visit.
REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0725
Date of REC Opinion
19 Oct 2015
REC opinion
Further Information Favourable Opinion