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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study at 18 months

Awards & highlights

RECONSTRUCT Trial 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.

RECONSTRUCT Trial Eligibility Criteria

Inclusion Criteria

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

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I am 50 years old or older.

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

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

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

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

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My condition did not improve with medication as per guidelines.

RECONSTRUCT Trial 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

RECONSTRUCT 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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

865 Previous Clinical Trials

526,800 Total Patients Enrolled

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

1 Previous Clinical Trials

100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the greatest number of individuals participating in this experiment?

"Affirmative. As per clinicaltrials.gov, this medical research study is actively seeking enrolment and opened on May 10th 2022 with the latest change to its description being made November 23rd of that year. The trial requires 30 patients from a single site for participation."

Answered by AI

Is this research endeavor presently welcoming new participants?

"The clinical trial is ongoing, with the first post date reported to be May 10th 2022 and the most recent update on November 23rd of the same year. This information can be found on clinicaltrials.gov."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant

Reade De Leacy 2022. "Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05337696.