MDR - Biomet Cannulated Screws

Running, not enrolling

Conditions studied: Fractures, Bone, Fracture Multiple

In brief

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).

Key facts

Study ID

NCT04002518

Run by

Zimmer Biomet

People needed

51

Starts

2019-08-07

Expected to finish

2026-10-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• SI joint disruptions
• Intercondylar femur fractures
• Subtalar arthrodesis
• 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.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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