The RESTORE study, a prospective randomized clinical trial evaluating the safety and efficacy of LDGraft in single-level anterior lumbar interbody fusion (ALIF), achieved a significant milestone with the treatment of its first participant. LDGraft is an innovative combination product that delivers a biomimetic release of recombinant human bone morphogenetic protein-2 (rhBMP-2) through a biodegradable polymer, developed to address bone defects in spinal fusion.
RESTORE (A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion) aims to show the potential of LDGraft to promote optimal bone growth and fusion at the surgical site, advancing options for patients undergoing ALIF. Through its encapsulation technology, LDGraft tempers the bioavailability of the molecule, particularly during the initial high inflammatory phase of bone healing. LDGraft received an FDA breakthrough device designation in 2023.
“This is an important study, and we are optimistic that LDGraft’s biomimetic release technology could represent a major step forward in spinal fusion treatment,” said Robyn Cochrane, QARA and Clinical Director. “By addressing the limitations of current fusion materials, LDGraft has the potential to revolutionize how we treat spinal fusion patients with the opportunity to bring this technology to many other applications.”
The RESTORE study is enrolling eligible participants and will evaluate both clinical fusion outcomes and patient-reported outcomes over the coming months.
The RESTORE study, a prospective randomized clinical trial evaluating the safety and efficacy of LDGraft in single-level anterior lumbar interbody fusion (ALIF), achieved a significant milestone with the treatment of its first participant. LDGraft is an innovative combination product that delivers a biomimetic release of recombinant human...
The RESTORE study, a prospective randomized clinical trial evaluating the safety and efficacy of LDGraft in single-level anterior lumbar interbody fusion (ALIF), achieved a significant milestone with the treatment of its first participant. LDGraft is an innovative combination product that delivers a biomimetic release of recombinant human bone morphogenetic protein-2 (rhBMP-2) through a biodegradable polymer, developed to address bone defects in spinal fusion.
RESTORE (A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion) aims to show the potential of LDGraft to promote optimal bone growth and fusion at the surgical site, advancing options for patients undergoing ALIF. Through its encapsulation technology, LDGraft tempers the bioavailability of the molecule, particularly during the initial high inflammatory phase of bone healing. LDGraft received an FDA breakthrough device designation in 2023.
“This is an important study, and we are optimistic that LDGraft’s biomimetic release technology could represent a major step forward in spinal fusion treatment,” said Robyn Cochrane, QARA and Clinical Director. “By addressing the limitations of current fusion materials, LDGraft has the potential to revolutionize how we treat spinal fusion patients with the opportunity to bring this technology to many other applications.”
The RESTORE study is enrolling eligible participants and will evaluate both clinical fusion outcomes and patient-reported outcomes over the coming months.
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