FractureNCT04730739
FastFrame Knee Spanning and Damage Control Kit PMCF
A study of Fracture and Fractures, Bone, run by Zimmer Biomet at 1 site in United States.
Trial summary
The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture, Fractures, Bone, Fractures, Closed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2021to 22 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FastFrame™ External Fixation System Post-Market Clinical Follow-Up Study: Knee Spanning Kit and Damage Control Kit
The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.
Read the 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.
- Conditions
- Fracture, Fractures, Bone, Fractures, Closed, Fractures, Open
- Being tested
- FastFrame External Fixation System - Knee Spanning or Damage Control Kit
- Keywords
- External fixator, temporary stabilization
- Medical subject headings
- Fractures, Bone, Fractures, Closed, Fractures, Open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastFrame External Fixation System - Knee Spanning or Damage Control KitDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| FastFrame External Fixation System - Knee Spanning or Damage Control Kit | Experimental | The patient must have been treated with either Knee Spanning or Damage Control FastFrame External Fixation System. Receives: Device: FastFrame External Fixation System - Knee Spanning or Damage Control Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.).
Measured: 2-4 weeks postoperative
Secondary outcomes (1)
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.
Measured: 2-4 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start18 Jun 2021
- Primary completion30 Jun 2024
- Study completion22 Jul 2024
Why it stopped: Product will not be taken to EU, thus no PMCF requirements.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FractureStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin Osborn, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730739
- Sponsor's protocol ID
- CMU2017-95T
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2021
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FastFrame™ External Fixation System Post-Market Clinical Follow-Up Study: Knee Spanning Kit and Damage Control Kit
- ClinicalTrials.gov ID
- NCT04730739
- Acronym / sponsor ID
- CMU2017-95T
- Conditions
- Fracture, Fractures, Bone, Fractures, Closed, Fractures, Open
- Keywords
- External fixator, temporary stabilization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Product will not be taken to EU, thus no PMCF requirements.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FastFrame External Fixation System - Knee Spanning or Damage Control Kit | Experimental | Device: FastFrame External Fixation System - Knee Spanning or Damage Control KitThe patient must have been treated with either Knee Spanning or Damage Control FastFrame External Fixation System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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*
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FastFrame External Fixation System - Knee Spanning or Damage Control KitThe 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. | Device | FastFrame External Fixation System - Knee Spanning or Damage Control Kit |
Primary outcome
Number of Participants With Device-related Adverse Events and Device Deficiencies
Time frame: 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.).
1 secondary outcome
Number of Participants With Another Device-related Adverse Events
Time frame: 2-4 weeks postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Osborn study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Fracture and Fractures, Bone, run by Zimmer Biomet at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Device-related Adverse Events and Device Deficiencies (time frame: 2-4 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.