Zimmer® MotionLoc® in Distal Tibia Fractures

Zimmer Biomet

Status

Completed

Conditions

Distal Tibia Fractures

Treatments

Device: Zimmer MotionLoc Screw

Study type

Observational

Funder types

Industry

Identifiers

NCT02717546

CSE2014-08T

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.