An interventional study of FastFrame External Fixation System - Knee Spanning or Damage Control Kit in Fracture, Fractures, Bone and Fractures, Closed, sponsored by Zimmer Biomet. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Zimmer Biomet · Not applicable, Interventional, and Treatment
The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.
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.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's enrollment of 33 is below the median of 80 across 458 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patient must have been treated with either Knee Spanning or Damage Control FastFrame External Fixation System.
Device: 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.
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
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
| Milestone | FastFrame External Fixation System - Knee Spanning or Damage Control Kit |
|---|---|
| Started | 33 |
| Completed | 32 |
| Not completed | 1 |
| Withdrew: Death | 1 |
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.).
| Participants | FastFrame External Fixation System - Knee Spanning or Damage Control Kit |
|---|---|
| Number of Participants With Device-related Adverse Events and Device Deficiencies | 0 |
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.
| Participants | FastFrame External Fixation System - Knee Spanning or Damage Control Kit |
|---|---|
| Number of Participants With Another Device-related Adverse Events | 2 |
Collected over Per the protocol, International Organization for Standardization (ISO) definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 2 - 4 weeks follow-up or study completion (including lost to follow-up), whichever came first.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FastFrame External Fixation System - Knee Spanning or Damage Control Kit | 1/33 (3%) | 2/33 (6.1%) | 0/33 (0%) |
| Event | FastFrame External Fixation System - Knee Spanning or Damage Control Kit |
|---|---|
| Not RelatedMusculoskeletal and connective tissue disorders | 1/33 |
| Not RelatedInfections and infestations | 1/33 |
| Age, Categorical(Participants) | FastFrame External Fixation System - Knee Spanning or Damage Control Kit |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 27 |
| >=65 years | 6 |
| Age, Continuous(years) | FastFrame External Fixation System - Knee Spanning or Damage Control Kit |
|---|---|
| Mean | 49.28 (20 to 78) |
| Sex: Female, Male(Participants) | FastFrame External Fixation System - Knee Spanning or Damage Control Kit |
|---|---|
| Female | 7 |
| Male | 26 |
| Ethnicity (NIH/OMB)(Participants) | FastFrame External Fixation System - Knee Spanning or Damage Control Kit |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 31 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | FastFrame External Fixation System - Knee Spanning or Damage Control Kit |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 9 |
| White | 22 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | FastFrame External Fixation System - Knee Spanning or Damage Control Kit |
|---|---|
| United States | 33 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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