MDR - Biomet Cannulated Screws

NCT04002518 | Active Not Recruiting FDA Device

• 1 other identifier: MDRG2017-89MS-35T
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Fractures, Bone; Fracture Multiple

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Device Performance and Clinical Benefits Assessed by a Patient Questionnaire Case Report Form

  Out to 12+ months

• Device Performance and Clinical Benefits Assessed by a Follow-Up Analysis Case Report Form

  Out to 12+ months

Study Arms (2)

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

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.

Large Screws; Small Screws

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (3)

Zimmer Biomet

Warsaw, Indiana, 46580, United States

Location

Orthopedic Foot and Ankle Center

Worthington, Ohio, 43085, United States

Location

Associated Foot & Ankle Centers of Northern Virginia

Lake Ridge, Virginia, 22192, United States

Location

MeSH Terms

Conditions

Fractures, Bone; Fractures, Multiple

Condition Hierarchy (Ancestors)

Wounds and Injuries; Multiple Trauma

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 28, 2019
• Study Start: August 7, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)