Clinical trial NCT04730739: FastFrame Knee Spanning and Damage Control Kit PMCF
Official title: FastFrame™ External Fixation System Post-Market Clinical Follow-Up Study: Knee Spanning Kit and Damage Control Kit
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fracture
Fractures, Bone
Fractures, Closed
Fractures, Open
Keywords: External fixator, temporary stabilization
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2021-01-29
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Device-related Adverse Events and Device Deficiencies
timeFrame: 2-4 weeks postoperative
Secondary outcomes:
measure: Number of Participants With Another Device-related Adverse Events
timeFrame: 2-4 weeks postoperative
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: Zimmer Biomet
name: Erin Osborn
role: STUDY_DIRECTOR
References: