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MDR - Biomet Cannulated Screws

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

NCT04002518•Zimmer Biomet

View on ClinicalTrials.gov

Summary

Detailed Description

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). 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+11 more 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 informed consent.

Locations (3)

Zimmer Biomet

Warsaw, Indiana, United States

Orthopedic Foot and Ankle Center

Worthington, Ohio, United States

Associated Foot & Ankle Centers of Northern Virginia

Lake Ridge, Virginia, United States

Key Dates

Start Date

August 7, 2019

Primary Completion Date

June 1, 2026

Completion Date

December 1, 2026

Last Updated

October 30, 2025

Enrollment

ACTUAL participants

Conditions

Fractures, BoneFracture Multiple

Interventions

Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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MDR - Biomet Cannulated Screws

Inclusion Criteria

Exclusion Criteria

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