MDR - Biomet Cannulated Screws

Fractures, Bone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04002518
• Other study ID #: MDRG2017-89MS-35T
• Status: Enrolling by invitation
• Start date: August 7, 2019
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fracture Multiple
• Fractures, Bone

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Associated Foot & Ankle Centers of Northern Virginia	Lake Ridge	Virginia
United States	Zimmer Biomet	Warsaw	Indiana
United States	Orthopedic Foot and Ankle Center	Worthington	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Device Performance and Clinical Benefits Assessed by a Patient Questionnaire Case Report Form	Performance and clinical benefits demonstrated by the assessment of survey questions.	Out to 12+ months
Secondary	Device Performance and Clinical Benefits Assessed by a Follow-Up Analysis Case Report Form	Performance and clinical benefits demonstrated by the assessment of fracture healing/fusion and survey questions.	Out to 12+ months