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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02717546
Registration number
NCT02717546
Ethics application status
Date submitted
22/02/2016
Date registered
23/03/2016
Date last updated
4/08/2021
Titles & IDs
Public title
Zimmer® MotionLoc® in Distal Tibia Fractures
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Scientific title
Zimmer® MotionLoc® in Distal Tibia Fractures: An Observational Study
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Secondary ID [1]
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CSE2014-08T
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Distal Tibia Fractures
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Zimmer MotionLoc Screw
Group One - Distal Tibia Fracture repaired with Zimmer MotionLoc Screw
Treatment: Devices: Zimmer MotionLoc Screw
Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up
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Assessment method [1]
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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.
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Timepoint [1]
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3 months
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Primary outcome [2]
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Number of Participants With Radiographic Fracture Healing of the Tibia at 3 Months Follow-up
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Assessment method [2]
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Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).
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Timepoint [2]
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3 months
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Secondary outcome [1]
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Complications
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Assessment method [1]
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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.
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Weeks Follow-up
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Assessment method [2]
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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.
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Timepoint [2]
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6 weeks
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Secondary outcome [3]
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Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Months Follow-up
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Assessment method [3]
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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.
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 12 Months Follow-up
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Assessment method [4]
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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.
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Weeks Follow-up
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Assessment method [5]
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Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).
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Timepoint [5]
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6 weeks
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Secondary outcome [6]
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Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Months Follow-up
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Assessment method [6]
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Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).
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Timepoint [6]
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6 months
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Secondary outcome [7]
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Number of Participants With Radiographic Fracture Healing of the Tibia at 12 Months Follow-up
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Assessment method [7]
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Radiographic fracture healing is defined as bridging of three of the four cortices without fracture line (as seen on x-ray/CT).
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Timepoint [7]
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12 months
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Eligibility
Key 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".
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/01/2020
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Sample size
Target
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Accrual to date
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Final
32
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Mackay Specialist Day Hospital - Mount Pleasant
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Recruitment postcode(s) [1]
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QLD 4740 - Mount Pleasant
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Illinois
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Country [2]
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United States of America
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State/province [2]
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Indiana
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Country [3]
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United States of America
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State/province [3]
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Oregon
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Country [4]
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Italy
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State/province [4]
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Siena
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Country [5]
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Korea, Republic of
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State/province [5]
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Seoul
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Country [6]
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United Kingdom
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State/province [6]
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West Midlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Zimmer Biomet
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02717546
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kacy Arnold, RN MBA
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Address
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Zimmer Biomet
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02717546
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