Zimmer® MotionLoc® in Distal Tibia Fractures

Zimmer® MotionLoc® in Distal Tibia Fractures: An Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Distal Tibia Fractures
• Intervention / Treatment: Device: Zimmer MotionLoc Screw

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Australia
  • Mount Pleasant, Australia, QLD 4740
    • Mackay Specialist Day Hospital
• Italy
  • Siena, Italy
    • Azienda Ospedaliera Universitaria Senese
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
• United Kingdom
  • West Midlands
    • Dudley, West Midlands, United Kingdom, DY12HQ
      • The Dudley Group NHS Foundation Trust
• United States
  • Illinois
    • Springfield, Illinois, United States, 62703
      • Springfield Clinic
  • Indiana
    • Indianapolis, Indiana, United States, 46266
      • Indiana University
  • Oregon
    • Eugene, Oregon, United States, 97408
      • Donald B. Slocum Research and Education Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group One; Distal Tibia Fracture repaired with Zimmer MotionLoc Screw	Device: Zimmer MotionLoc Screw; Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 weeks
Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 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.	6 months
Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 12 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.	12 months
Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Weeks Follow-up	Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).	6 weeks
Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Months Follow-up	Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).	6 months
Number of Participants With Radiographic Fracture Healing of the Tibia at 12 Months Follow-up	Radiographic fracture healing is defined as bridging of three of the four cortices without fracture line (as seen on x-ray/CT).	12 months

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Kacy Arnold, RN MBA, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): December 5, 2019
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Distal Tibia Fracture Screw
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: CSE2014-08T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided