25 Participants NeededMy employer runs this trial

Diagnostic Ankle Nano-Arthroscopy for Ankle Fracture

ND
VL
Overseen ByVicki L Jones, MEd
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Missouri-Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the frequency of ankle injuries, specifically osteochondral lesions (joint surface damage), associated with a type of ankle fracture known as pilon fractures. By using a tiny camera (diagnostic ankle nano-arthroscopy) during surgery, doctors aim to better understand these lesions and potentially adjust treatment plans. The trial includes individuals with pilon fractures requiring temporary external fixation but excludes those with previous ankle surgery or existing arthritis. As an unphased study, this trial allows participants to contribute to advancing medical knowledge and improving future treatment strategies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this diagnostic ankle nano-arthroscopy is safe?

Research has shown that the Diagnostic Ankle Nano-Arthroscopy is generally safe and well-tolerated. Studies indicate that this procedure often leads to significant pain relief and carries a low risk of complications. The NanoScope™ system used in these procedures is very small, requiring only a tiny incision. This minimizes the risk of soft tissue damage and reduces the chance of causing new injuries during the procedure.

In other studies, patients who underwent similar procedures with this technology reported excellent recovery. Most experienced significant improvements, with very few reporting any issues. Overall, evidence suggests that this treatment is safe and effective for diagnosing and treating ankle injuries.12345

Why are researchers excited about this trial?

Researchers are excited about Diagnostic Ankle Nano-Arthroscopy because it offers a minimally invasive way to evaluate ankle fractures. Unlike traditional methods that might rely heavily on imaging techniques like X-rays or MRIs, this approach uses the Arthrex Nanoscope to directly visualize the inside of the ankle joint. This allows for a more precise assessment of osteochondral lesions, potentially leading to more accurate diagnoses and tailored treatments. By offering real-time visualization, this technique could improve the management of ankle fractures and help in faster recovery planning.

What evidence suggests that diagnostic ankle nano-arthroscopy is effective for detecting osteochondral lesions in pilon fractures?

Research has shown that nano-arthroscopy, a tiny camera used to examine joints, can assist with ankle injuries. One study found that patients with ankle problems experienced less pain and improved mobility after treatment. Nano-arthroscopy requires only a small incision, reducing the risk of damage to nearby tissues. Another study found that patients who underwent a second arthroscopy for ankle issues generally reported satisfaction with the results. In this trial, participants will undergo Diagnostic Ankle Nano-Arthroscopy to evaluate osteochondral lesions. Overall, nano-arthroscopy offers a promising method for diagnosing and potentially improving conditions like bone and cartilage damage in the ankle.56789

Who Is on the Research Team?

BC

Brett Crist

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) with a specific type of severe ankle fracture (tibial plafond, AO/OTA 43-C), caused by closed injury and needing temporary external fixation. People with certain other types of ankle fractures are not included.

Inclusion Criteria

I am 18 or older with a closed 43-C type tibial plafond fracture needing external fixation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Operative Phase

Eligible patients are identified and consented for external fixation and possible diagnostic ankle nano-arthroscopy. The Arthrex Nanoscope is introduced into the tibiotalar joint to evaluate for osteochondral lesions.

1 day
1 visit (in-person)

Imaging Phase

Postoperative CT scans are obtained as part of standard preoperative planning for definitive fixation. A blinded surgeon reviews the CT scans to assess for possible OCLs.

1-2 weeks

Surgeon Decision-Making Analysis

Surgeons review patient histories, radiographs, and CTs to develop a preoperative plan. They then reassess with knowledge of OCL findings to determine if management strategy changes.

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tracking outcomes and complications through standard of care follow-up.

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Diagnostic Ankle Nano-Arthroscopy

Trial Overview

The study uses a small camera procedure called nano-arthroscopy during initial treatment to look for cartilage damage in the ankle after serious fractures. The goal is to see how often these injuries occur and if finding them changes later treatment plans.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Diagnostic Ankle Nano-ArthroscopyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials
387
Recruited
629,000+

Arthrex, Inc.

Industry Sponsor

Trials
48
Recruited
30,200+

Citations

Outcomes Following Repeat Ankle Arthroscopy and ...

We identified 14 patients who underwent repeat arthroscopy and microfracture for symptomatic OLTs. Patients reported reasonable satisfaction ( ...

Patient-Reported Outcomes of Microfracture, Nanofracture ...

The aim of this study is to evaluate the early patient-reported outcomes of microfracture, nanofracture, and antegrade drilling methods in talus ...

Outcomes Following the Arthroscopic Chondro-Gide Repair of ...

We demonstrated a statistically significant improvement in ankle pain and functional outcomes following arthroscopic Chondro-Gide repair of OCDs of the talus.

Osteochondral lesions of the talar head - Foot & Ankle Surgery

This was the first reported case to describe nano-arthroscopy in the talonavicular joint and to utilize the combina- tion of demineralized bone graft with ...

Nano Arthroscopy Benefits for Treating Foot and Ankle Injuries

Nano arthroscopy requires just a tiny incision and is designed to reduce the risk of harm to soft tissue and the possibility of iatrogenic injury.

Clinical Outcomes of Nano Arthroscopy in the Office Setting for ...

The current study demonstrates that IONA treatment of posterior ankle impingement results in significant pain reduction, a low complication rate and excellent ...

Diagnostic Ankle Nano-Arthroscopy for Ankle Fracture

Participants are monitored for safety and effectiveness after treatment, including tracking outcomes and complications through standard of care ...

Clinical Outcomes of Nano Arthroscopy in the Office Setting for ...

The current study demonstrates that IONA treatment of anterior ankle impingement results in significant pain reduction, a low complication rate, and excellent ...

Nano-Instrumentation Achieves Superior Foot & Ankle ...

The needle-sized, 1.9-mm chip-on-the-tip NanoScope™ system enables diagnosis of arthritis and cartilage injuries as well as arthroscopic treatments of the foot ...