Active, not recruitingNCT04002518Updated Jul 9, 2026

MDR - Biomet Cannulated Screws

An observational study in Fractures, Bone and Fracture Multiple, sponsored by Zimmer Biomet. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.

Primary conditionFractures, MultipleRegistry: Fractures, BoneReclassifiedWhy we changed it

Registry

Fractures, Bone — the first condition term the registry derived for this study.

ClinicalTrials.gg

Fractures, Multiple

Why

The study's listed conditions name Fractures, Multiple, a narrower term within Fractures, Bone.

Confidence

High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →

Wrong?

Tell us the study's main condition →

Sponsored by Zimmer Biomet · Observational

Study type: Observational
Model: Cohort
Time perspective: Other
Enrollment: 51
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Fractures, Bone
Fracture Multiple

Browse trials for

Fractures, Bone 723Registry's first term
Fractures, Multiple 14Primary · reclassified

In context

Fractures, Multiple Reclassified

14 studies on the registry are indexed under Fractures, Multiple; 4 are open to participants now.

Browse Fractures, Multiple studies →

Lead sponsor

Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.

Browse Zimmer Biomet studies →

Compared within Fractures, Multiple, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fractures, Bone. The counts are of registry records indexed under each term, refreshed daily. How we classify →

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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:
1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
2. Arthrodesis of the foot, wrist and elbow.
3. Small and long bone osteotomies.
4. 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:
1. Fixation of fractures in long bones and long bone fragments.
2. Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
3. 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:
1. Slipped capital femoral epiphysis
2. Pediatric femoral neck fractures
3. Tibial plateau fractures
4. SI joint disruptions
5. Intercondylar femur fractures
6. Subtalar arthrodesis
7. 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.

Exclusion criteria

Exclusion Criteria:

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 .

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Study design

Observational model: Cohort
Time perspective: Other
Enrollment: 51 participants (actual)
Patient registry: No

Groups and cohorts

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

Interventions

DeviceBiomet 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.

What researchers measure

Primary outcomes

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.
Time frame: Out to12+ months

Secondary outcomes

Device Performance and Clinical Benefits Assessed by a Patient Questionnaire Case Report Form
Performance and clinical benefits demonstrated by the assessment of survey questions.
Time frame: 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.
Time frame: Out to 12+ months

Study locations

3 sites

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2019 to primary completion in Jun 2026, 82 months.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 18, 2019
First posted: Jun 28, 2019
StartActual: Aug 7, 2019
Primary completionActual: Jun 18, 2026
CompletionEst.: Oct 2026
Last update: Jul 9, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04002518
Lead sponsor: Zimmer Biomet
Responsible party: Sponsor
First posted: Jun 28, 2019
Start date: Aug 7, 2019
Primary completion: Jun 18, 2026
Completion: Oct 2026 (estimated)
Last update: Jul 9, 2026

Study contacts

Hillary Overholser

study director · Zimmer Biomet

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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