NCT03625544

MagnetOs™ Granules vs. Autograft in Instrumented Posterolateral Spinal Fusion

A Randomized Intra-Patient Controlled Trial of MagnetOs™ Granules vs. Autograft in Instrumented Posterolateral Spinal Fusion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: M.C. Kruyt, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate non-inferiority of MagnetOs™ Granules as an alternative to autologous bone graft in adult patients undergoing an instrumented posterolateral fusion of the thoracolumbar, lumbar or lumbosacral spine, in terms of efficacy and safety. After instrumentation and based on randomization, one side of the spine will be grafted with MagnetOs™ Granules and the other side with autologous bone graft. Thereby, each patient serves as its own control.

Detailed description

Posterolateral spinal fusion is currently performed by using large amounts of autologous bone graft. Drawbacks of bone grafting include the need for an additional surgical procedure, limited supply, sub-optimal bone quality in osteoporotic patients and harvesting morbidity, which led to the development of numerous bone graft substitutes. Recently, a promising synthetic graft substitute has been developed that has shown favorable results in pre-clinical studies. This product, MagnetOs™ Granules, is CE-marked and received 510(k) clearance from the US Food and Drug Administration. The aim of the current study is to demonstrate non-inferiority of MagnetOs™ Granules compared to autograft in instrumented posterolateral spinal fusion, in terms of efficacy and safety. This study is designed as a multicenter, observer blinded, randomized, controlled non-inferiority trial with intra-patient comparisons. A total of 100 adult patients qualified for posterolateral spinal fusion in the thoracolumbar and lumbosacral region (T10-S2) will be recruited and enrolled. According to a randomization scheme, one side of the spine will be grafted with the MagnetOs™ Granules and the other side with bone harvested from the iliac crest and local bone. The rest of the surgical procedure will be according to standard care. The primary efficacy outcome is the rate of successful posterolateral spinal fusion after one year, assessed on CT-scans. Non-inferiority of the MagnetOs™ condition compared to the autograft condition will be assessed using a McNemar's test. The primary safety outcome is the number and nature of (serious) adverse events related to the surgical procedure compared to control populations from literature. Secondary outcomes are the comparison to its predicate (AttraX® Putty), relation between posterolateral fusion and interbody fusion after one-year, posterolateral spinal fusion rate after two years, relevance of iliac crest donor site pain and the incidence of long-term complication and relation with risk factors in the combined population of this study and a recently completed clinical trial.

Conditions

• Spinal Fusion

Interventions

Type	Name	Description
PROCEDURE	Instrumented posterolateral spinal fusion	Instrumented posterolateral spinal fusion, with or without an additional interbody device
DEVICE	MagnetOs™ Granules	8-10cc of MagnetOs™ Granules per spinal level at the randomized allocation side of the spine (left or right)
PROCEDURE	Autologous bone graft	8-10cc autologous bone graft per spinal level at the control side of the spine (left or right). This can be a combination of local bone and iliac crest bone, but at least 50% of the volume has to be iliac crest bone graft.

Timeline

• Start date: 2018-07-04
• Primary completion: 2023-10-30
• Completion: 2024-10-07
• First posted: 2018-08-10
• Last updated: 2024-12-11

Locations

5 sites across 1 country: Netherlands