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Zimmer® MotionLoc® in Distal Tibia Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717546
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment
Distal Tibia Fractures 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.

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Zimmer® MotionLoc® in Distal Tibia Fractures: An Observational Study
Study Start Date : February 2016
Actual Primary Completion Date : December 5, 2019
Actual Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Radiographic Fracture Healing of the Tibia [ Time Frame: 3 months ]
    Radiographic fracture healing is defined as bridging of three of the four cortices as seen on x-ray/CT.

  2. Clinical Fracture Healing of the Tibia [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Complications [ Time Frame: 6 weeks, 3, 6, and 12 months ]
    Adverse Events

  2. Radiographic Fracture Healing of the Tibia [ Time Frame: 6 weeks, 3, 6, and 12 months ]
    Radiographic fracture healing is defined as bridging of three of the four cortices as seen on x-ray/CT.

  3. Clinical Fracture Healing of the Tibia [ Time Frame: 6 weeks, 3, 6, and 12 months ]
    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.

  4. Callus size & distribution [ Time Frame: 6 weeks, 3, 6, and 12 months ]
    Callus size & distribution at 6 weeks, 3, 6, and 12 months post-surgery. Callus size of the anterior, posterior, and medial aspect will be assessed for each time point using a validated and published computational method.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717546


Locations
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United States, Illinois
Springfield Clinic
Springfield, Illinois, United States, 62703
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46266
United States, Oregon
Donald B. Slocum Research and Education Foundation
Eugene, Oregon, United States, 97408
Australia
Mackay Specialist Day Hospital
Mount Pleasant, Australia, QLD 4740
Italy
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, West Midlands, United Kingdom, DY12HQ
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kacy Arnold, RN MBA Zimmer Biomet
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02717546    
Other Study ID Numbers: CSE2014-08T
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zimmer Biomet:
Distal Tibia Fracture Screw
Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries