Clinical trial NCT04002518: MDR - Biomet Cannulated Screws
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Fractures, Bone
Fracture Multiple
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-06-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study populations will be a consecutive series of subjects that have received the Biomet Cannulated Screw. Patients will be enrolled into one of the two identified groups: Small Screws (3.0mm and 4.0mm), or Large Screws (5.0mm, 6.5mm and 8.0mm).

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.

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.

Primary outcomes:
measure: Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events
timeFrame: Out to12+ months
Secondary outcomes:
measure: Device Performance and Clinical Benefits Assessed by a Patient Questionnaire Case Report Form
timeFrame: Out to 12+ months
measure: Device Performance and Clinical Benefits Assessed by a Follow-Up Analysis Case Report Form
timeFrame: Out to 12+ months
Other outcomes:
Locations:
city: Warsaw
country: United States
facility: Zimmer Biomet
state: Indiana
city: Worthington
country: United States
facility: Orthopedic Foot and Ankle Center
state: Ohio
city: Lake Ridge
country: United States
facility: Associated Foot & Ankle Centers of Northern Virginia
state: Virginia
Study officials:
affiliation: Zimmer Biomet
name: Erin Osborn
role: STUDY_DIRECTOR
References: