Distal Tibia FracturesNCT02717546

Zimmer® MotionLoc® in Distal Tibia Fractures

An observational study of Distal Tibia Fractures, run by Zimmer Biomet at 7 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Distal Tibia Fractures
What is being tested?: Zimmer MotionLoc Screw
Type of treatment: Medical device
How many people: 32 participants
Where: 7 sitesin 5 countries
Study dates: Feb 2016to 15 Jan 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Primary Care Clinic

Who may be able to join

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".

Who cannot join

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).

Show all 11Show fewer

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.

Trial locations and contacts

7 sites in 5 countries.

Country

City, postcode or hospital

7 sites in 5 countries

United States3 sites

Donald B. Slocum Research and Education Foundation
Eugene, Oregon, 97408
Indiana University
Indianapolis, Indiana, 46266
Springfield Clinic
Springfield, Illinois, 62703

Other trials in United States

Australia1 site

Mackay Specialist Day Hospital
Mount Pleasant, QLD 4740

Other trials in Australia

Italy1 site

Azienda Ospedaliera Universitaria Senese
Siena

Other trials in Italy

South Korea1 site

Korea University Anam Hospital
Seoul

Other trials in South Korea

United Kingdom1 site

The Dudley Group NHS Foundation Trust
Dudley, West Midlands, DY12HQ

Other trials in United Kingdom

About this study

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

Read the 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.

Conditions: Distal Tibia Fractures
Being tested: Zimmer MotionLoc Screw
Keywords: Distal Tibia Fracture Screw

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02717546
Study group	Role	What they receive
Group One		Distal Tibia Fracture repaired with Zimmer MotionLoc Screw Receives: Device: Zimmer MotionLoc Screw

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 3 months

Secondary outcomes (7)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201615 Jan 2020

First posted23 Mar 2016 (estimated)
Study startFeb 2016
Primary completion5 Dec 2019
Study completion15 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Distal Tibia FracturesStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02717546
Sponsor's protocol ID: CSE2014-08T
Status last verified: Jul 2021
First submitted: 22 Feb 2016
Last updated: 4 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
X-BS Ortho Bone Graft Study
Orthopedic Disorder, Trauma Injury
Recruiting
Elastic Nailing With Kirschner Wires Versus Plate Fixation for Distal Tibial Fractures in Adolescents
Distal Tibial Fracture, Tibial Fracture
Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures
Distal Tibial Fracture, Tibial Fractures
Recruiting
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures
Fracture Healing, Treatment Duration
Active, not recruitingObservational study
Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®
Hip Fractures, Tibial Fractures

All Distal Tibia Fractures trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Zimmer® MotionLoc® in Distal Tibia Fractures: An Observational Study
ClinicalTrials.gov ID: NCT02717546
Acronym / sponsor ID: CSE2014-08T
Conditions: Distal Tibia Fractures
Keywords: Distal Tibia Fracture Screw
Study type: Observational
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Feb 2016
Primary completion: 5 Dec 2019 (actual)
Study completion: 15 Jan 2020 (actual)
First posted: 23 Mar 2016 (estimated)
Results: Posted 4 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Callus size of the anterior, posterior, and medial aspect will be assessed for each time point using a validated and published computational method.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Group One	–	Device: Zimmer MotionLoc ScrewDistal Tibia Fracture repaired with Zimmer MotionLoc Screw

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Primary Care Clinic

Key inclusion criteria (5 listed)

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".

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zimmer MotionLoc ScrewPatients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.	Device	Group One

Primary outcome

Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up
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. Minimum (worst) score possible is 0 and Maximum (best) score possible is 12.
Number of Participants With Radiographic Fracture Healing of the Tibia at 3 Months Follow-up
Time frame: 3 months
Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).

7 secondary outcomes

Complications
Time frame: 12 months
Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Weeks Follow-up
Time frame: 6 weeks
Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Months Follow-up
Time frame: 6 months
Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 12 Months Follow-up
Time frame: 12 months
Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Weeks Follow-up
Time frame: 6 weeks
Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Months Follow-up
Time frame: 6 months
Number of Participants With Radiographic Fracture Healing of the Tibia at 12 Months Follow-up
Time frame: 12 months

Results and safety

Results posted to the registry on 4 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group One	32	20

Primary outcome: Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up

Time frame: 3 months. Mean (95% Confidence Interval). Unit: score on scale

Measure	Group One n = 29
Value	7.5 (6.6 to 8.4)

Population analysed: Thirty-two subjects were enrolled globally. At 3 months follow-up, 29 subjects completed their visit and contributed to study data collection, thus 29 subjects were analyzed for this 3 month primary endpoint. However, the participation flow reports 20 subjects completed, which is reporting the number of subjects that were available for data collection at the 12 month follow-up.

Primary outcome: Number of Participants With Radiographic Fracture Healing of the Tibia at 3 Months Follow-up

Time frame: 3 months. Number. Unit: participants

Measure	Group One n = 29
Value	3

Population analysed: Thirty-two subjects were enrolled globally. After 3 months follow-up, 29 subjects remained in the study for data collection, thus 29 subjects were analyzed for the primary endpoint. However, the participation flow reports 20 subjects completed, which is reporting the number of subjects that were available for data collection at the 12 month follow-up.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group One	1 of 32 (3.1%)	6 of 32 (18.8%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Distal Tibia Fractures

Not yet recruiting
X-BS Ortho Bone Graft Study
Orthopedic Disorder, Trauma Injury
Recruiting
Elastic Nailing With Kirschner Wires Versus Plate Fixation for Distal Tibial Fractures in Adolescents
Distal Tibial Fracture, Tibial Fracture
Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures
Distal Tibial Fracture, Tibial Fractures
Recruiting
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures
Fracture Healing, Treatment Duration
Active, not recruitingObservational study
Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®
Hip Fractures, Tibial Fractures

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kacy Arnold, RN MBA study director

Zimmer Biomet

7 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Distal Tibia Fractures, run by Zimmer Biomet at 7 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Australia, Italy, South Korea, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02717546.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.