Bone Graft Substitutes for Spine Fusion

Recruiting at 12 trial locations

Overseen By Pete weiman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OssDsign

Disqualifiers: Others

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

Compensation: Varies

Number of Visits: 4

Duration: Surgery and immediate post-operative period

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather information on the effectiveness of a bone graft substitute from OssDsign® in real-world settings for individuals undergoing spine fusion surgery. Spine fusion stabilizes the spine and is often necessary for back pain or spinal issues. The study will observe patients scheduled for this surgery whose doctors have deemed the OssDsign® bone graft suitable. Ideal participants are those needing spinal fusion surgery and willing to adhere to the study's requirements for two years post-operation. As a Phase 4 trial, this study involves a treatment already FDA-approved and proven effective, aiming to understand its benefits for a broader patient population.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for OssDsign® and spine fusion?

Research has shown that OssDsign, a bone graft substitute used in spine fusion surgeries, is safe based on current data. A review of 511 units used post-market revealed no major safety issues. Some side effects were reported, but none were serious enough to raise safety concerns. Additionally, the FDA has approved OssDsign for use as a bone filler, indicating it has passed certain safety checks for other applications.

In studies involving OssDsign, all patients achieved successful spinal fusion and reported reduced pain and improved quality of life. This suggests the treatment is generally well-tolerated. Although no treatment is entirely without risk, the available evidence supports the safety of OssDsign for spine fusion procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

OssDsign® is unique because it uses a bioactive bone graft substitute designed to enhance spine fusion surgery. Unlike traditional bone grafts that rely on the patient's own bone or donor bone, OssDsign® incorporates a proprietary calcium phosphate technology that promotes bone growth and integration with existing bone structures. Researchers are excited because this approach has the potential to improve fusion outcomes and reduce complications, offering a promising alternative to enhance recovery and stability in patients undergoing spine fusion procedures.

What evidence suggests that OssDsign® is effective for spine fusion?

Research has shown that OssDsign's bone graft substitute is highly effective for spine fusion surgery. In real-world cases, it achieves an 88.4% success rate, even for patients with complex spine issues. Some studies reported a 100% success rate over two years, noting improvements in patients' quality of life. These findings suggest that OssDsign could be an excellent choice for those needing spinal fusion surgery. ^{4 6 7 8 9}

Who Is on the Research Team?

Melanie Marshall

Principal Investigator

OssDsign

Are You a Good Fit for This Trial?

Inclusion Criteria

The patient has been diagnosed as a candidate for spinal fusion surgery for which the surgeon has decided an OssDsign® bone graft is appropriate.

The patient is ≥21 years old.

The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spine fusion surgery with OssDsign® bone grafts

Surgery and immediate post-operative period

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular visits at 4, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• OssDsign®
• Spine Fusion

Who Is Running the Clinical Trial?

OssDsign

Lead Sponsor

Trials

2

Recruited

320+

Citations

1. ossdsign.com ossdsign.com/news

News - OssDsign AB OssDsign announces remarkable real-world results with 88.4% fusion rate in a highly complex patient cohort from the spinal fusion registry PROPEL Arrow.

2. thespinemarketgroup.com thespinemarketgroup.com/ossdsign-announces-remarkable-real-world-results-with-88-4-fusion-rate-in-a-highly-complex-patient-cohort-from-the-spinal-fusion-registry-propel/

OssDsign announces remarkable real-world results with ... The results show an outstanding fusion rate of 88.4% in the real-world setting in a highly complex patient cohort.

3. beckersspine.com beckersspine.com/biologics/ossdesigns-spinal-fusion-biologic-sees-strong-results-in-complex-patients/

OssDesign's spinal fusion biologic sees strong results in ... OssDesign's Catalyst nanosynthetic bone graft putty saw an 88.4% fusion rate in highly complex spine patients, according to results from its Propel study.

4. mb.cision.com mb.cision.com/Main/18020/4132066/3378148.pdf

24-month follow up data from the clinical study of OssDsign ... The newly published peer-reviewed data, demonstrating 100% fusion rate and improved quality of life outcomes, validates. OssDsign Catalyst's ...

5. odtmag.com odtmag.com/breaking-news/study-complete-spinal-fusion-possible-with-ossdsign-catalyst/

Study: Complete Spinal Fusion Possible With OssDsign ... TOP FUSION study results demonstrate OssDsign's nanosynthetic bone graft fosters complete spinal fusion after two years.

6. ossdsign.com ossdsign.com/upl/files/195439.pdf

Preliminary Post-market Safety Review In this report, we describe the preliminary post-market safety data consisting of Adverse Events and Complaints following the sale of 511 units of OssDsign ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05329129

NCT05329129 | OssDsign® Spine Registry Study ("Propel") This multi-center study (up to 15 US study sites) is a post market, prospective, observational spine fusion registry.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K232315.pdf

K232315 Trade/Device Name - accessdata.fda.gov Device Description: OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign ...

9. ossdsign.com ossdsign.com/upl/files/198793/ossdsign-annual-report-2023-en-spreads.pdf?t=770803740

Annual Report 2023 The peer reviewed article presents data showing complete spinal fusion 6 months after surgery with the novel nanosynthetic bone graft OssDsign.