FastFrame Knee Spanning and Damage Control Kit PMCF

NCT04730739 | Terminated Results FDA Device

• 1 other identifier: CMU2017-95T
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.

Conditions

Fracture; Fractures, Bone; Fractures, Closed; Fractures, Open

Keywords

External fixator, temporary stabilization

Outcome Measures

Primary Outcomes (1)

• 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.).

  2-4 weeks postoperative

Secondary Outcomes (1)

• Number of Participants With Another Device-related Adverse Events

  2-4 weeks postoperative

Study Arms (1)

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.

Device: FastFrame External Fixation System - Knee Spanning or Damage Control Kit

Interventions

FastFrame External Fixation System - Knee Spanning or Damage Control Kit DEVICE

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.

FastFrame External Fixation System - Knee Spanning or Damage Control Kit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21212, United States

Location

MeSH Terms

Conditions

Fractures, Bone; Fractures, Closed; Fractures, Open

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Octavia Gladden, Clinical Research Speaclist
• Organization: Zimmer Biomet

octavia.gladden@zimmerbiomet.com

704.493.0178

Study Officials

• Erin Osborn

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 29, 2021
• Study Start: June 18, 2021
• Primary Completion: June 30, 2024
• Study Completion: July 22, 2024
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)