What side effects are associated with this type of intervention?

Common treatments for broken bones, particularly those involving external fixation systems like the FastFrame External Fixation System, include the use of frames and pins or screws to stabilize and immobilize fractures. Known side effects of these treatments can include infection at the pin or screw sites, pain and discomfort, potential for pin loosening or breakage, and skin irritation or damage. Additionally, there may be a risk of delayed bone healing or nonunion, and in some cases, patients may experience limited mobility or stiffness in the affected area.

What prior FDA approvals exist?

The FDA has approved various treatments for broken bones, including external fixation devices similar to the FastFrame External Fixation System. These devices stabilize and immobilize fractures externally using a frame and pins or screws. External fixation is often used in trauma cases to provide immediate stabilization and allow for proper alignment and healing of the bone. Other related treatments include internal fixation methods such as intramedullary nails and plates, which are also FDA-approved for fracture management.

What other types of research exist?

Promising novel alternatives to the FastFrame External Fixation System for broken bones in 2024 include: 1) Anterior Vertebral Body Tethering (VBT) which is minimally invasive and preserves motion, 2) Posterior Dynamic Deformity Correction Devices which offer vertebral growth modulation, and 3) Titanium Clip-Screw Implants which have shown safety and efficacy in early clinical studies. These alternatives aim to provide better correction, lower complication rates, and improved patient outcomes.

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External Fixation System

FastFrame External Fixation for Broken Bones

N/A

Waitlist Available

Research Sponsored by Zimmer Biomet

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Patient must be 18 years of age or older

Must not have

Patient has an active or suspected infection

Patient has inadequate skin, bone, or neurovascular status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-4 weeks postoperative

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of the FastFrame External Fixation System, which is used to stabilize broken bones from the outside. It targets patients with severe bone injuries who need temporary support before getting a permanent fix. The system works like a brace, using a frame and pins to keep bones steady while they heal.

Who is the study for?

This trial is for adults over 18 who need the FastFrame External Fixation System for knee-related fractures, specifically around or between the femur and tibia. It's not suitable for prisoners, those unable to consent or follow instructions due to mental conditions, individuals with poor skin/bone health, active infections, pregnant/breastfeeding women, or substance abusers.

What is being tested?

The study tests the safety and performance of two kits: Knee Spanning and Damage Control from the FastFrame External Fixation System. These are used for temporary stabilization of severe bone fractures near or in the knee when surgery isn't an option.

What are the potential side effects?

While specific side effects aren't listed here, external fixation systems can generally cause discomfort at pin sites, potential infection risk around where pins enter the skin, swelling or stiffness in nearby joints during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need temporary support for a broken femur or tibia.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I currently have or might have an infection.

Select...

I have problems with my skin, bones, or blood vessels/nerves.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-4 weeks postoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-4 weeks postoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-4 weeks postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency and incidence of device-related adverse events and device deficiencies

Secondary study objectives

All other adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: FastFrame External Fixation System - Knee Spanning or Damage Control KitExperimental Treatment1 Intervention

The patient must have been treated with either Knee Spanning or Damage Control FastFrame External Fixation System.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for broken bones include casting, internal fixation, and external fixation. External fixation systems, such as the FastFrame External Fixation System, stabilize and immobilize fractures externally using a frame and pins or screws inserted into the bone. This method allows for precise alignment of the bone fragments and can be adjusted without additional surgery. It is particularly useful for complex fractures or when internal fixation is not feasible. The primary mechanism of action is to maintain bone stability and proper alignment during the healing process, which is crucial for optimal recovery and function. This approach minimizes the risk of further injury and promotes effective bone healing.

Surgical stabilization of postpartum symphyseal instability: two cases and a review of the literature.Early controlled passive motion improves early fracture alignment and structural properties in a closed extra-articular metacarpal fracture in a rabbit model.The effects of external mechanical stimulation on the healing of diaphyseal osteotomies fixed by flexible external fixation.