Vertebral Implant for Compression Fractures

(RECONSTRUCT Trial)

No longer recruiting at 3 trial locations

Overseen By Sydney Edwards

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Infection, Uncontrolled diabetes, Neurologic signs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Day 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new implant called the Vertebral Implant PEEK (VIP) for individuals with painful spine fractures unresponsive to regular treatments. It aims to determine if this implant can reduce pain and improve movement. The trial seeks participants with osteoporosis-related spine fractures less than 12 weeks old, still causing pain despite other treatments. Those with recent spine fractures who find regular care ineffective might find this trial suitable. As an unphased trial, it offers a unique opportunity to explore a new treatment option that could potentially enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking anticoagulants (blood thinners) like warfarin regularly, you may not be eligible to participate.

What prior data suggests that the Vertebral Implant PEEK (VIP) implant is safe for treating vertebral compression fractures?

Research has shown that the Vertebral Implant PEEK (VIP) is generally well-accepted by patients. Studies have found that using these implants for spine fractures often leads to good results, particularly in reducing pain. Reports from past patients indicate few serious side effects. In some cases, combining these implants with cementoplasty, a procedure where bone cement is added for extra support, has also been successful. Overall, research suggests that this treatment is safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Vertebral Implant PEEK (VIP) implant is unique because it offers a new approach to treating vertebral compression fractures, especially for those who haven't found relief with conservative methods like pain medications, physical therapy, or bracing. What sets the VIP implant apart is its material, PEEK (polyether ether ketone), which is known for its strength and biocompatibility, potentially leading to better integration with bone and less risk of complications. Researchers are excited about this treatment because it could provide a more durable and stable solution for patients, reducing pain and improving mobility more effectively than current options.

What evidence suggests that the Vertebral Implant PEEK (VIP) implant is effective for vertebral compression fractures?

Research has shown that the Vertebral Implant PEEK (VIP), which participants in this trial will receive, can help reduce pain in people with vertebral compression fractures. One study found that patients' pain levels dropped significantly, from a score of 5.5 to 1.5 on a standard pain scale. Another study reported positive results with these implants, noting improvements after treating fractures with the PEEK material. This suggests that the VIP implant might benefit those who haven't found relief with other treatments. Overall, the implant shows promise in managing symptoms of vertebral compression fractures. ^{2 3 4 6 7}

Who Is on the Research Team?

Tomoyoshi Shigematsu, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 50 years old or older.

ASA < 4

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

Exclusion Criteria

Pedicles not large enough to accept V-STRUT© instrumentation and implants

Involved in medical litigation including workers' compensation

My bone condition is sclerotic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Vertebral Implant PEEK (VIP) device for the treatment of vertebral compression fractures

Day 1

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Vertebral Implant PEEK (VIP) implant

Trial Overview 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.

How Is the Trial Designed?

Group I: Participants with vertebral compression fractures Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

In a study involving eight adult sheep, implants coated with NanoMetalene (NM) showed significantly greater bone ingrowth and ongrowth compared to uncoated polyether ether ketone (PEEK) implants, indicating that NM enhances bone integration.

At both 4 and 8 weeks post-surgery, the NM-coated implants demonstrated new bone formation that tracked along the titanium layer, while PEEK implants exhibited nonreactive fibrous tissue, suggesting that NM may improve clinical outcomes for bone fusion devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The in vivo response to a novel Ti coating compared with polyether ether ketone: evaluation of the periphery and inner surfaces of an implant. Walsh, WR., Pelletier, MH., Christou, C., et al.[2023]

In a matched cohort study of 462 patients (154 with PEEK rods and 308 with titanium rods) undergoing lumbar spine fusion, there was no significant difference in the risk of adjacent segment disease (ASD) between the two rod systems, suggesting that PEEK rods do not reduce ASD risk as previously theorized.

Patients who received PEEK rods had a significantly lower likelihood of readmission compared to those with titanium rods, with no nonunions or complications observed in the PEEK group, indicating a potential safety advantage for PEEK rods in lumbar spine fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do PEEK Rods for Posterior Instrumented Fusion in the Lumbar Spine Reduce the Risk of Adjacent Segment Disease? Hirt, D., Prentice, HA., Harris, JE., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05337696

Circumferential Vertebral Reconstruction of Osteoporotic ... The RECONSTRUCT study is a multi-center, prospective, single arm, post-market, pilot study to evaluate clinical and radiologic outcome data regarding the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11686317/

Polyetheretherketone polymer transpedicular vertebral ... Percutaneous transpedicular fixation of vertebral compression fracture using polyetheretherketone implants has favorable patient outcomes in terms of pain and ...

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1161174/full

Innovative minimally invasive implants for osteoporosis ... Similarly, the VAS score decreased from 5.5 to 1.5, with six cases of bone cement leakage and one adjacent vertebral fracture (occurred at the 6 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10067727/

Innovative minimally invasive implants for osteoporosis ... Percutaneous transpedicular fixation by peek polymer implants combined with cementoplasty for vertebral compression fractures: a pilot study.

5. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/38609-three-generations-of-treatments-for-osteoporotic-vertebral-fractures-what-is-the-evidence

Three generations of treatments for osteoporotic vertebral ... The aim of this review is to report the most relevant evidences on effectiveness, safety, and indications of the currently available vertebral augmentation ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05337696

Circumferential Vertebral Reconstruction of Osteoporotic ... The RECONSTRUCT study is a multi-center, prospective, single arm, post-market, pilot study to evaluate clinical and radiologic outcome data regarding the ...

7. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/08465371241228256

A Multicentre Pilot Study of Feasibility and Safety Percutaneous transpedicular fixation by PEEK polymer implants combined with cementoplasty for vertebral compression fractures: a pilot study.