Zimmer® MotionLoc® in Distal Tibia Fractures

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-01-15

Brief Summary

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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.

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Detailed Description

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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

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Distal Tibia Fractures

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group One

Distal Tibia Fracture repaired with Zimmer MotionLoc Screw

Zimmer MotionLoc Screw

Intervention Type DEVICE

Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.

Interventions

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Zimmer MotionLoc Screw

Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No