Fractures, BoneNCT04002518

MDR - Biomet Cannulated Screws

An observational study of Fractures, Bone and Fracture Multiple, run by Zimmer Biomet at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Fractures, Bone, Fracture Multiple
What is being tested?: Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.
Type of treatment: Medical device
How many people: 51 participants
Where: 3 sitesUnited States
Study dates: 7 Aug 2019to Oct 2026
Phase: Observational
Are there results?: Not yet: the study is under way

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: The study populations will be a consecutive series of subjects that have received the Biomet Cannulated Screw. Patients will be enrolled into one of the two identified groups: Small Screws (3.0mm and 4.0mm), or Large Screws (5.0mm, 6.5mm and 8.0mm).

Who may be able to join

Patient must be 18 years of age or older.
All patients operated on for the following indications:
Group 1, Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:
Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
Arthrodesis of the foot, wrist and elbow.
Small and long bone osteotomies.

Show all 21Show fewer

Fracture fixation of small bones, small bone fragments and long bones.
Group 2, Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
Fixation of fractures in long bones and long bone fragments.
Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
Arthrodesis and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.
Group 3, Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:
Slipped capital femoral epiphysis
Pediatric femoral neck fractures
Tibial plateau fractures
SI joint disruptions
Intercondylar femur fractures
Subtalar arthrodesis
Fixation of pelvis and iliosacral joint
Patients must have the ability and willingness to follow instructions, including control of weight and activity levels.
Patient must have a good nutritional state.

Who cannot join

Infections.
Patient conditions including blood supply limitations, insufficient quantity or quality of bone.
Patients with mental or neurologic conditions who are unwilling or incapable fo following postoperative care instructions.
Foreign body sensitivity where material sensitivity is suspected or unknown, testing is to be completed prior to implantation of the device.
Patient is a prisoner.
Patient is a current alcohol or drug abuser.
Patient is known to be pregnant or breastfeeding.
Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Associated Foot & Ankle Centers of Northern Virginia
Lake Ridge, Virginia, 22192
Zimmer Biomet
Warsaw, Indiana, 46580
Orthopedic Foot and Ankle Center
Worthington, Ohio, 43085

Other trials in United States

About this study

Official title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) - A Retrospective/Prospective Study

Read the detailed description

Safety will be established by recording the incidence and frequency of complications and adverse events. Relationship of the events to either implant or instrumentation should be specified.

Performance and clinical benefits will be assessed by analyzing fracture healing/fusion and the overall pain and functional performance of subjects who received the Biomet Cannulated Bone Screws by recording survey questions. Zimmer Biomet defines the expected performance rate for Cannulated Screws for long and small bone fractures to be a union rate of at least 81% at 8-12 months.

Conditions: Fractures, Bone, Fracture Multiple
Being tested: Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.
Medical subject headings: Fractures, Bone, Fractures, Multiple

What participants receive

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

Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.Device
Treatment of identified conditions, i.e. fracture fixation, arthrodesis, osteotomy, with a cannulated screw.

Study groups in NCT04002518
Study group	Role	What they receive
Small Screws		Patients who have surgically been treated with a 3.0mm or 4.0mm screw. Receives: Device: Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.
Large Screws		Patients who have surgically been treated with a 5.0mm, 6.5mm or 8.0mm screw. Receives: Device: Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.

What is being measured

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

Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events
Assessment of safety by recording and analyzing the incidence and frequency of revisions, complications, and adverse events.
Measured: Out to12+ months

Secondary outcomes (2)

Device Performance and Clinical Benefits Assessed by a Patient Questionnaire Case Report Form
Performance and clinical benefits demonstrated by the assessment of survey questions.
Measured: Out to 12+ months
Device Performance and Clinical Benefits Assessed by a Follow-Up Analysis Case Report Form
Performance and clinical benefits demonstrated by the assessment of fracture healing/fusion and survey questions.
Measured: Out to 12+ months

Timeline

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

7 Aug 2019Oct 2026

First posted28 Jun 2019
Study start7 Aug 2019
Primary completion18 Jun 2026
Study completionOct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Fractures, BoneStudies 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: Cohort
Time perspective: Other
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04002518
Sponsor's protocol ID: MDRG2017-89MS-35T
Status last verified: Jul 2026
First submitted: 18 Jun 2019
Last updated: 9 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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

Active, not recruitingPhase 2
BDSF Vs DHS With Anterotational Screw in Vertical FNF
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Stoppa Approach Vs Anterior & Posterior Fixation in Management of BC Fracture Acetabulum
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Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
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Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers
Hand Fractures

All Fractures, Bone trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) - A Retrospective/Prospective Study
ClinicalTrials.gov ID: NCT04002518
Acronym / sponsor ID: MDRG2017-89MS-35T
Conditions: Fractures, Bone, Fracture Multiple
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 51 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: 7 Aug 2019 (actual)
Primary completion: 18 Jun 2026 (actual)
Study completion: Oct 2026 (estimated)
First posted: 28 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Safety will be established by recording the incidence and frequency of complications and adverse events. Relationship of the events to either implant or instrumentation should be specified.

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 2

Arm	Type	Receives
Small Screws	–	Device: Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.Patients who have surgically been treated with a 3.0mm or 4.0mm screw.
Large Screws	–	Device: Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.Patients who have surgically been treated with a 5.0mm, 6.5mm or 8.0mm screw.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study populations will be a consecutive series of subjects that have received the Biomet Cannulated Screw. Patients will be enrolled into one of the two identified groups: Small Screws (3.0mm and 4.0mm), or Large Screws (5.0mm, 6.5mm and 8.0mm).

Key inclusion criteria (21 listed)

Patient must be 18 years of age or older.
Group 1, Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:
Group 2, Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
Group 3, Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:
Patients must have the ability and willingness to follow instructions, including control of weight and activity levels.

Key exclusion criteria (8 listed)

Infections.
Patient conditions including blood supply limitations, insufficient quantity or quality of bone.
Patients with mental or neurologic conditions who are unwilling or incapable fo following postoperative care instructions.
Foreign body sensitivity where material sensitivity is suspected or unknown, testing is to be completed prior to implantation of the device.
Patient is a prisoner.

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
Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.Treatment of identified conditions, i.e. fracture fixation, arthrodesis, osteotomy, with a cannulated screw.	Device	Large Screws, Small Screws

Primary outcome

Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events
Time frame: Out to12+ months
Assessment of safety by recording and analyzing the incidence and frequency of revisions, complications, and adverse events.

2 secondary outcomes

Device Performance and Clinical Benefits Assessed by a Patient Questionnaire Case Report Form
Time frame: Out to 12+ months
Device Performance and Clinical Benefits Assessed by a Follow-Up Analysis Case Report Form
Time frame: Out to 12+ months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Individual participant dataSharing planned: No

Related trials for Fractures, Bone

Active, not recruitingPhase 2
BDSF Vs DHS With Anterotational Screw in Vertical FNF
Evaluation of BDSF in FNF
Active, not recruitingPhase 2
Stoppa Approach Vs Anterior & Posterior Fixation in Management of BC Fracture Acetabulum
Evaluation of Isolated Stoppa Approach in BC Fracture Acetabulum
Not yet recruiting
Allograft vs. Autograft Nonunion
Nonunion Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Not yet recruiting
Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers
Hand 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.

Hillary Overholser study director

Zimmer Biomet

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Fractures, Bone and Fracture Multiple, run by Zimmer Biomet at 3 sites in United States.

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 21 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

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?

Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events (time frame: Out to12+ months). 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 NCT04002518.

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 9 Jul 2026.