Fracture, Fractures, Bone, Fractures, Closed, Fractures, Open
Conditions
Keywords
External fixator, temporary stabilization
Brief summary
The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.
Detailed description
Study Title: FastFrame™ External Fixation System Post-Market Clinical Follow-Up Study (Knee Spanning Kit and Damage Control Kit) Sponsor: Zimmer Biomet Study Design: Prospective enrollment, prospective follow-up, single cohort study Clinical Phase: Postmarket Number of Sites: Up to three sites Study Duration per Subject: Subjects will be enrolled in the study until the time of exchange of their FastFrame Kit to another device. Typically, this exchange occurs 2-4 weeks after injury. Primary Objective: The objective of this observational, prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation. Primary Endpoint: Frequency and incidence of device-related adverse events and device deficiencies before the FastFrame External Fixation System is exchanged by another device (i.e. plates, screws, etc.). Secondary Endpoint: Adverse events that occur between application of the FastFrame External Fixation System and exchange with another device that do not fall within the primary endpoint.
Interventions
DEVICEFastFrame External Fixation System - Knee Spanning or Damage Control Kit
The FastFrame External Fixation Systems - Knee Spanning Kit and Damage Control Kit are single-use external fixators that are sterile packed with all required components for convenience of the end user.
Sponsors
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be 18 years of age or older * Patient must be treated with either the Knee Spanning or Damage Control FastFrame External Fixation System according to the European Economic Area (EEA) indications\* EEA Indications (a subset of the cleared US indications): The FastFrame External Fixation System - Knee Spanning Kit is indicated for use in treatment of long bone (distal femur, proximal tibia) fractures. Specifically, the system is intended for temporary stabilization of open or closed fractures about the knee, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated. The FastFrame External Fixation System - Damage Control Kit is indicated for use in treatment of mid-shaft long bone (femur, tibia) fractures. Specifically, the system is intended for temporary stabilization of open or closed fractures of the femur and tibia, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated.
Exclusion criteria
* Patient has an active or suspected infection * Patient has conditions that limit their ability and/or willingness to follow instructions during the healing process * Patient has inadequate skin, bone, or neurovascular status * Patient is a prisoner * Patient is pregnant and/or breastfeeding * Patient is a known current alcohol and/or drug abuser in the opinion of the Investigator * Patient has a mental or neurologic condition that will not allow for proper Informed Consent and/or participation in follow-up program in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device-related Adverse Events and Device Deficiencies | 2-4 weeks postoperative | Frequency and incidence of device-related adverse events and device deficiencies before the FastFrame External Fixation System is exchanged by another device (i.e. plates, screws, etc.). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Another Device-related Adverse Events | 2-4 weeks postoperative | Adverse events that occur between application of the FastFrame External Fixation System and exchange with another device that do not fall within the primary endpoint. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FastFrame External Fixation System - Knee Spanning or Damage Control Kit The patient must have been treated with either Knee Spanning or Damage Control FastFrame External Fixation System.
FastFrame External Fixation System - Knee Spanning or Damage Control Kit: The FastFrame External Fixation Systems - Knee Spanning Kit and Damage Control Kit are single-use external fixators that are sterile packed with all required components for convenience of the end user. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | FastFrame External Fixation System - Knee Spanning or Damage Control Kit |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 49.28 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 33 |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 2 / 33 |
Outcome results
Primary
Number of Participants With Device-related Adverse Events and Device Deficiencies
Frequency and incidence of device-related adverse events and device deficiencies before the FastFrame External Fixation System is exchanged by another device (i.e. plates, screws, etc.).
Time frame: 2-4 weeks postoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FastFrame External Fixation System - Knee Spanning or Damage Control Kit | Number of Participants With Device-related Adverse Events and Device Deficiencies | 0 Participants |
Secondary
Number of Participants With Another Device-related Adverse Events
Adverse events that occur between application of the FastFrame External Fixation System and exchange with another device that do not fall within the primary endpoint.
Time frame: 2-4 weeks postoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FastFrame External Fixation System - Knee Spanning or Damage Control Kit | Number of Participants With Another Device-related Adverse Events | 2 Participants |