Zimmer® MotionLoc® in Distal Tibia Fractures

Zimmer Biomet32 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Distal Tibia Fractures

Interventions

Zimmer MotionLoc ScrewDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

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

Outcomes

Primary Outcomes

Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up

This measure will be assessed using the Function Index for Trauma (FIX-IT). The instrument quantifies clinical healing by assessing weight-bearing and fracture site pain on an ordinal scale. Minimum (worst) score possible is 0 and Maximum (best) score possible is 12.

Time frame: 3 months

Number of Participants With Radiographic Fracture Healing of the Tibia at 3 Months Follow-up

Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).

Time frame: 3 months

Secondary Outcomes

Complications

Adverse Events were summed for all time points for the totality of the study. I.E. - complications reported for all sites at 6 weeks, 3 months, 6 months, and 12 months were summed and reported as a single secondary outcome measure for the study.

Time frame: 12 months

Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Weeks Follow-up

This measure will be assessed using the Function Index for Trauma (FIX-IT) The instrument quantifies clinical healing by assessing weight-bearing and fracture site pain on an ordinal scale. Minimum (worst) score possible is 0 and Maximum (best) score possible is 12.

Time frame: 6 weeks

Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Months Follow-up

Time frame: 6 months

Data from ClinicalTrials.gov

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