NCT02717546

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
5 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 4, 2021

Completed
Last Updated

August 4, 2021

Status Verified

July 1, 2021

Enrollment Period

3.8 years

First QC Date

February 22, 2016

Results QC Date

May 10, 2021

Last Update Submit

July 13, 2021

Conditions

Distal Tibia Fractures

Keywords

Distal Tibia Fracture Screw

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Complications

    12 months

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

    6 weeks

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

    6 months

  • Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 12 Months Follow-up

    12 months

  • Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Weeks Follow-up

    6 weeks

  • +2 more secondary outcomes

Study Arms (1)

Group One

Distal Tibia Fracture repaired with Zimmer MotionLoc Screw

Device: Zimmer MotionLoc Screw

Interventions

Zimmer MotionLoc ScrewDEVICE

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

Group One

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • 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".

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Springfield Clinic

Springfield, Illinois, 62703, United States

Location

Indiana University

Indianapolis, Indiana, 46266, United States

Location

Donald B. Slocum Research and Education Foundation

Eugene, Oregon, 97408, United States

Location

Mackay Specialist Day Hospital

Mount Pleasant, QLD 4740, Australia

Location

Azienda Ospedaliera Universitaria Senese

Siena, Italy

Location

Korea University Anam Hospital

Seoul, South Korea

Location

The Dudley Group NHS Foundation Trust

Dudley, West Midlands, DY12HQ, United Kingdom

Location

Results Point of Contact

Title
Ryan Boylan, Clinical Affairs Manager
Organization
Zimmer Biomet
ryan.boylan@zimmerbiomet.com
574.527.7934

Study Officials

  • Kacy Arnold, RN MBA

    Zimmer Biomet

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 23, 2016

Study Start

February 1, 2016

Primary Completion

December 5, 2019

Study Completion

January 15, 2020

Last Updated

August 4, 2021

Results First Posted

August 4, 2021

Record last verified: 2021-07

Locations

KR(1)AU(1)IT(1)GB(1)US(3)