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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Fractures, Bone; Fracture Multiple
• Intervention / Treatment: Device: Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.

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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; Treatment of identified conditions, i.e. fracture fixation, arthrodesis, osteotomy, with a cannulated screw.
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.; Treatment of identified conditions, i.e. fracture fixation, arthrodesis, osteotomy, with a cannulated screw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Out to12+ months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hillary Overholser, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Multiple Trauma; Fractures, Multiple; Fractures, Bone; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Ulcer Agents; Histamine H2 Antagonists; Cimetidine
• Other Study ID Numbers: MDRG2017-89MS-35T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes