MDR - Biomet Cannulated Screws

• Conditions: Fractures, Bone; Fracture Multiple

• Registration Number: NCT04002518
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-28
• Study Start: 2019-08-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events	Out to12+ months	Assessment of safety by recording and analyzing the incidence and frequency of revisions, complications, and adverse events.

Secondary Outcome Measures

Name	Time	Method
Device Performance and Clinical Benefits Assessed by a Patient Questionnaire Case Report Form	Out to 12+ months	Performance and clinical benefits demonstrated by the assessment of survey questions.
Device Performance and Clinical Benefits Assessed by a Follow-Up Analysis Case Report Form	Out to 12+ months	Performance and clinical benefits demonstrated by the assessment of fracture healing/fusion and survey questions.

Trial Locations

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