MDR - Biomet Cannulated Screws

NCT ID: NCT04002518

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-07
• Study Completion Date: 2026-12-31

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).

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.

Conditions

Fractures, Bone; Fracture Multiple

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Small Screws

Patients who have surgically been treated with a 3.0mm or 4.0mm screw.

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

Intervention Type: DEVICE

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.

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

Intervention Type: DEVICE

Treatment of identified conditions, i.e. fracture fixation, arthrodesis, osteotomy, with a cannulated screw.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hillary Overholser

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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

Countries

United States

Other Identifiers

MDRG2017-89MS-35T

Identifier Type: -

Identifier Source: org_study_id