Vertebral Implant PEEK (VIP) implant for Vertebral Compression Fractures

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Vertebral Compression Fractures+3 More
Vertebral Implant PEEK (VIP) implant - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The RECONSTRUCT study is a single site, prospective, single arm, post-market, pilot study to evaluate clinical and radiologic outcome data regarding the use of the Vertebral Implant PEEK (VIP) implant in the treatment of symptomatic, acute (<8week) vertebral compression fractures who have failed conservative care strategies.

Eligible Conditions

  • Vertebral Compression Fractures
  • Osteoporotic Vertebral Compression Fractures

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Vertebral Compression Fractures

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: End of study at 18 months

6 months
Lost to follow up rate
The Oswestry Disability Index
Vertebral Height
Visual Analogue Symptom (VAS)
Day 1
Cement leakage
Fluoroscopy dose
Fluoroscopy time
Procedure duration
Volume of cement injected
Month 18
Number of adverse events

Trial Safety

Safety Progress

1 of 3

Other trials for Vertebral Compression Fractures

Trial Design

1 Treatment Group

Participants with vertebral compression fractures
1 of 1
Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Vertebral Implant PEEK (VIP) implant · No Placebo Group · N/A

Participants with vertebral compression fracturesExperimental Group · 2 Interventions: Vertebral Implant PEEK Procedure, Vertebral Implant PEEK (VIP) implant · Intervention Types: Procedure, Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: end of study at 18 months
Closest Location: Icahn School of Medicine at Mount Sinai · New York, NY
Photo of icahn school of medicine at mount sinai 1Photo of icahn school of medicine at mount sinai 2Photo of icahn school of medicine at mount sinai 3
1997First Recorded Clinical Trial
1 TrialsResearching Vertebral Compression Fractures
529 CompletedClinical Trials

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
761 Previous Clinical Trials
493,630 Total Patients Enrolled
Reade De Leacy, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
100 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a positive ODI or VAS score at the screening visit.
You have a type A1.1, A1.2, A1.3, A2.
You have a pedicle diameter of 5.5mm or 6.5mm.
You have osteoporotic compression fractures of the thoracolumbar spine (T9 -L5).
Fracture age of <8 weeks as indicated by onset of pain or known antecedent traumatic event with corresponding evidence of acuity on MRI (T1 and STIR sequences) or radioisotope bone scan.
Failure of conservative management strategies for compression fractures resulting in inadequately controlled pain and/or patient immobility.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.