LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

Recruiting Phase 1 Phase 2 Interventional Study
Degenerative Disc Disease Lumbar Disc Disease Spine Disease Lumbar Spine Degeneration
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
22 – 80
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Locate Bio Pty Ltd · Industry
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About This Trial

The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of patients with lumbar degenerative disc disease (DDD).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Skeletally mature adults ≥22 and ≤80 years at the time of surgery 2. Willing and able to give written informed consent and comply with study protocol and postoperative management program 3. Degenerative disc disease of the lumbosacral spine in one level (L3 to S1) requiring f…
Contacts

Robyn Cochrane

+44 (0)115 784 0041

rcochrane@locatebio.com

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