← Back to Search

Implant

Vertebral Implant for Compression Fractures (RECONSTRUCT Trial)

N/A

Recruiting

Led By Reade De Leacy, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Age ≥ 50

Osteoporotic compression fractures of the thoracolumbar spine (T9 -L5)

Must not have

Sclerotic cancellous bone

Any previous surgical treatment (material or cement) in the targeted vertebra

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study at 18 months

Awards & highlights

Summary

This trial is looking at a new type of implant to treat vertebral compression fractures. The goal is to see if it is effective and safe.

Who is the study for?

This trial is for adults over 50 with recent (less than 8 weeks old) osteoporotic vertebral compression fractures in the thoracolumbar spine, who haven't improved with conservative treatments. Participants must have significant pain and/or mobility issues, appropriate bone structure for implant placement, and be generally healthy enough to undergo surgery.Check my eligibility

What is being tested?

The RECONSTRUCT study tests a new Vertebral Implant PEEK (VIP) procedure on patients with specific types of spinal fractures due to osteoporosis. It's a single-group study focusing on how well the VIP implant helps relieve symptoms and improve spine stability after other treatments have failed.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include typical risks associated with surgical procedures such as infection, bleeding, nerve damage or worsening pain. There might also be specific complications related to the implant like rejection or failure.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 50 years old or older.

Select...

I have osteoporosis-related spine fractures between T9 and L5.

Select...

My fracture is classified as a type A1 to A3 according to Magerl.

Select...

My bone is the right size for 5.5mm or 6.5mm implants.

Select...

My fracture is less than 8 weeks old, confirmed by an MRI or bone scan.

Select...

My condition did not improve with medication as per guidelines.

Exclusion Criteria

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

Select...

My bone condition is sclerotic.

Select...

I have had surgery on my spine involving materials or cement.

Select...

I have stable neurological conditions.

Select...

My spine condition is more severe than a mild slip.

Select...

I have severe heart or lung problems.

Select...

I was bedbound before my recent fracture.

Select...

I have severe back pain not caused by a recent fracture.

Select...

I do not have unstable bone fractures or tumors affecting the back of my body.

Select...

My spine's back parts are damaged.

Select...

I have symptoms due to pressure on my spinal cord or nerves.

Select...

I do not have any bone diseases except for osteoporosis.

Select...

I cannot have spinal surgery or general anesthesia due to a bleeding disorder or because I'm on blood thinners.

Select...

I do not have any infections, including in my spine.

Select...

I have signs of nerve damage from my physical exam.

Select...

I have severe back pain due to a herniated disc or spinal narrowing.

Select...

I have nerve-related symptoms due to a fracture or a fracture that is about to happen.

Select...

I do not have any health conditions that would prevent me from having surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study at 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study at 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study at 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of adverse events

Secondary outcome measures

Cement leakage

Fluoroscopy dose

Fluoroscopy time

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with vertebral compression fracturesExperimental Treatment2 Interventions

Participants with vertebral compression fractures who have failed conservative care strategies.

0 / 23Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

871 Previous Clinical Trials

527,270 Total Patients Enrolled

Reade De Leacy, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

1 Previous Clinical Trials

100 Total Patients Enrolled

~0 spots leftby Dec 2024

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.