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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fractures, Bone
- Sponsor
- Zimmer Biomet
- Enrollment
- 51
- Locations
- 3
- Primary Endpoint
- Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
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.
Investigators
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:
- •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).
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.
Outcomes
Primary Outcomes
Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events
Time Frame: Out to12+ months
Assessment of safety by recording and analyzing the incidence and frequency of revisions, complications, and adverse events.
Secondary Outcomes
- 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)