Vertebral Implant for Compression Fractures

(RECONSTRUCT Trial)

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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The RECONSTRUCT study is a multi-center, 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.

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 data supports the effectiveness of the Vertebral Implant PEEK (VIP) implant treatment for compression fractures?

Research shows that using PEEK implants in combination with other techniques can reduce pain and restore height in vertebral fractures, suggesting it may be effective for treating compression fractures. ^{1 2 3 4 5}

Is the Vertebral Implant PEEK (VIP) implant safe for use in humans?

Studies have evaluated the safety of PEEK implants for vertebral fractures, showing they are generally safe with some complications like cement leakage. Long-term studies have also been conducted, indicating safety over a 2-year follow-up period. ^{1 2 6 7 8}

How is the Vertebral Implant PEEK (VIP) treatment different from other treatments for compression fractures?

The Vertebral Implant PEEK (VIP) treatment is unique because it uses a special polymer implant to stabilize the spine, which can help restore height and reduce pain in vertebral fractures. Unlike traditional methods like vertebroplasty, which primarily use cement, this approach combines the implant with cementoplasty for added support and potentially better long-term outcomes. ^{1 2 4 8 9}

Research Team

Reade De Leacy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Transpedicular Fixation by PEEK Polymer Implants Combined with Cementoplasty for Vertebral Compression Fractures: A Pilot Study. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of pain reduction and height restoration post vertebral augmentation using a polyether ether ketone (PEEK) polymer implant for the treatment of split (Magerl A2) vertebral fractures: a prospective, long-term, non-randomized study. [2021]

3. China pubmed.ncbi.nlm.nih.gov

Corpectomy and expandable cage replacement versus third generation percutaneous augmentation system in case of vertebra plana: rationale and recommendations. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Percutaneous vertebral augmentation using drill rotation for osteoporotic vertebral compression fractures with intravertebral vacuum cleft. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Vertebroplasty is no Risk Factor for New Vertebral Fractures and Protects Against Further Height Loss (VERTOS IV). [2019]

6. United States 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. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Do PEEK Rods for Posterior Instrumented Fusion in the Lumbar Spine Reduce the Risk of Adjacent Segment Disease? [2021]

8. France pubmed.ncbi.nlm.nih.gov

Less invasive reduction and fusion of fresh A2 and A 3 traumatic L 1-L 4 fractures with a novel vertebral body augmentation implant and short pedicle screw fixation and fusion. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

[Vertebroplasty: a treatment option for osteoporotic compression fractures]. [2010]