Trial Outcomes & Findings for FastFrame Knee Spanning and Damage Control Kit PMCF (NCT NCT04730739)

Last Updated: 2025-02-10

Results Overview

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.).

Recruitment status

TERMINATED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

2-4 weeks postoperative

Results posted on

2025-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	33
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	1

Baseline Characteristics

FastFrame Knee Spanning and Damage Control Kit PMCF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FastFrame External Fixation System - Knee Spanning or Damage Control Kit n=33 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	49.28 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.).

Outcome measures

Outcome measures
Measure	FastFrame External Fixation System - Knee Spanning or Damage Control Kit n=33 Participants 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.
Number of Participants With Device-related Adverse Events and Device Deficiencies	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	FastFrame External Fixation System - Knee Spanning or Damage Control Kit n=33 Participants 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.
Number of Participants With Another Device-related Adverse Events	2 Participants

Adverse Events

FastFrame External Fixation System - Knee Spanning or Damage Control Kit

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	FastFrame External Fixation System - Knee Spanning or Damage Control Kit n=33 participants at risk 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.
Musculoskeletal and connective tissue disorders Not Related	3.0% 1/33 • 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. ISO definition is not materially different from clinicaltrials.gov definitions.
Infections and infestations Not Related	3.0% 1/33 • 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. ISO definition is not materially different from clinicaltrials.gov definitions.

Other adverse events

Adverse event data not reported

Additional Information

Octavia Gladden, Clinical Research Speaclist

Zimmer Biomet

Phone: 704.493.0178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place