LDGraft in one-level lumbar fusion for degenerative disc disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

LDGraft is being evaluated as an adjunct in single-level lumbar interbody fusion for degenerative disc disease. The study includes adults 22 to 80 who have failed conservative care and require fusion at one level. It is a combined Phase 1/2 trial focusing on safety and early effectiveness, with postoperative management and follow-up per protocol. Recruitment is at two sites in Georgia (Tbilisi and Kutaisi).

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Skeletally mature adults ≥22 and ≤80 years at the time of surgery
* Willing and able to give written informed consent and comply with study protocol and postoperative management program
* Degenerative disc disease of the lumbosacral spine in one level requiring fusion confirmed by patient history and radiographic imaging
* Preoperative Oswestry Disability Index score ≥ 35
* Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months

Exclusion Criteria:

* Previous lumbar spine instrumentation (i.e., anterior disc replacement, interspinous device) or a previous interbody fusion procedure in the lumbar spine
* More than one level lumbar spine level requiring fusion
* Three or more contiguous lumbar spine levels requiring decompression
* Known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any BMP-2 type recombinant proteins or peptides.
* Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women
* Presence of active malignancy
* Requires bone growth stimulation in the lumbar spine
* Active local or systemic infection
* Spondylolisthesis greater than Grade 2 (50% translation)
* Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping)
* Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis
* Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study
* Body Mass Index \> 40
* Insulin-dependent diabetes mellitus
* Osteopenia or osteoporosis of the spine
* Any secondary causes of osteoporosis or other conditions known to adversely affect osteogenesis
* Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs
* Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 code
* In the opinion of the investigator, the participant has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the product
* Radiographically compromised vertebral bodies at the index level due to current or past trauma
* Currently a prisoner
* Involved in active litigation relating to his/her spinal condition or workers compensation claimants.

Where it's running

• West Georgia Medical Center
  Tbilisi, Georgia Recruiting
• JSC Georgian Clinics Kutaisi Referral Hospital
  Tbilisi, Georgia Recruiting

Study contacts

• Study coordinator: Robyn Cochrane
• Email: rcochrane@locatebio.com
• Phone: +44115 7738447

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.