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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02717546




Registration number
NCT02717546
Ethics application status
Date submitted
22/02/2016
Date registered
23/03/2016
Date last updated
27/01/2020

Titles & IDs
Public title
Zimmer® MotionLoc® in Distal Tibia Fractures
Scientific title
Zimmer® MotionLoc® in Distal Tibia Fractures: An Observational Study
Secondary ID [1] 0 0
CSE2014-08T
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal Tibia Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Fracture Healing of the Tibia - Radiographic fracture healing is defined as bridging of three of the four cortices as seen on x-ray/CT.
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
Clinical Fracture Healing of the Tibia - 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.
Timepoint [2] 0 0
3 months
Secondary outcome [1] 0 0
Complications - Adverse Events
Timepoint [1] 0 0
6 weeks, 3, 6, and 12 months
Secondary outcome [2] 0 0
Radiographic Fracture Healing of the Tibia - Radiographic fracture healing is defined as bridging of three of the four cortices as seen on x-ray/CT.
Timepoint [2] 0 0
6 weeks, 3, 6, and 12 months
Secondary outcome [3] 0 0
Clinical Fracture Healing of the Tibia - 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.
Timepoint [3] 0 0
6 weeks, 3, 6, and 12 months
Secondary outcome [4] 0 0
Callus size & distribution - 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.
Timepoint [4] 0 0
6 weeks, 3, 6, and 12 months

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".
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Mackay Specialist Day Hospital - Mount Pleasant
Recruitment postcode(s) [1] 0 0
QLD 4740 - Mount Pleasant
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Oregon
Country [4] 0 0
Italy
State/province [4] 0 0
Siena
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Seoul
Country [6] 0 0
United Kingdom
State/province [6] 0 0
West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zimmer Biomet
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02717546
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications