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Bone screw safety under review: new study follows 51 patients

NCT ID NCT04002518

Disease control Sponsor: Zimmer Biomet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study looks at how well Biomet Cannulated Bone Screws work for fixing broken bones, fusing joints, or correcting bone cuts. It includes 51 adults who already had or will have surgery with these screws. Researchers track complications, revisions, and patient feedback to confirm the device is safe and performs as intended.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Biomet Cannulated Bone Screw System (a medical device used to fix broken bones)
What this could lead to
If successful, this study could confirm that these screws are safe and work well for fixing fractures, helping surgeons choose reliable hardware.
What could go wrong
This is a small, post-market study with only 51 participants, so results may not apply to all patients. The device is already approved, so no major breakthrough is expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

51 people

The number who actually took part.

Started

Aug 2019

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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.

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Conditions

The condition(s) this trial relates to.

bone fracture Fractures, Multiple

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fracture multiple Fractures, bone

Contacts and locations

Locations

  • Associated Foot & Ankle Centers of Northern Virginia

    Lake Ridge, Virginia, 22192, United States

  • Orthopedic Foot and Ankle Center

    Worthington, Ohio, 43085, United States

  • Zimmer Biomet

    Warsaw, Indiana, 46580, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.