KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Kuros Biosurgery AG
Send
Updated on 16 February 2024
See if I qualify
bone graft
leg pain
conservative management
spondylolisthesis
disc disease
conservative therapy
autograft
bed rest
fibrin
conservative treatment
scarring
osteophyte
intervertebral disc degeneration

Summary

The purpose of this study is to evaluate the safety and efficacy of KUR-113 Bone Graft (TGplPTH1-34 in fibrin) compared to local autograft for the treatment of Degenerative Disk Disease (DDD).

Description

Degenerative disc disease (DDD) is a common disorder of the lumbar spine. Clinically, DDD causes discogenic back pain and may cause related radicular, neuropathic, claudicatory, and referred pain.

This is a prospective, randomized, controlled, single-blind, dose-finding, multi-center study which intends to demonstrate the safety and efficacy of KUR-113 Bone Graft (TGplPTH1-34 in fibrin) versus local autograft. The study will enroll 50 patients with Degenerative Disk Disease (DDD) requiring single-level interbody fusion along with posterolateral fusion (PLF) with posterior fixation who meet eligibility criteria and agree to participate in the study. Safety and efficacy of KUR-113 Bone Graft will be evaluated by analyzing all clinical as well as radiological endpoints and adverse events. This phase 2a study is not powered to detect non-inferiority. All patients will undergo clinical and radiological assessments at initial hospital discharge (on average 3 days post-surgery), 6 weeks, 3, 6, 12 and 24 months.

Details
Condition Spinal Fusion, Intervertebral Disc Degeneration
Age 25years - 75years
Treatment TGplPTH1-34 in fibrin, Autologous Bone Graft
Clinical Study IdentifierNCT04294004
SponsorKuros Biosurgery AG
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

b'Written informed consent by the patient.'
b'Male or female patient \\u2265 25 up to and including 75 years old. Females of childbearing'
b'potential with a negative urine pregnancy test at Screening. Females of childbearing'
b'potential must agree to use acceptable contraception for at least 12 months after'
b'urgery and investigational product placement.'
b'Patients with degenerative disc disease with up to grade 1 spondylolisthesis and with'
b'leg pain requiring up to 3 levels of laminectomy/decompression and a single-level'
b'fusion (L2 - S1). DDD is defined by the presence of one or more of the following:'
b'instability (angulation \\u2265 5 degrees or translation \\u2265 3 mm on flexion/extension'
b'radiographs),'
b'osteophyte formation of facet joints or vertebral endplates,'
b'decreased disc height by > 2 mm, but dependent upon the spinal level,'
b'scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint'
b'capsule,'
b'disc degeneration and/or herniation,'
b'facet degeneration,'
b'vacuum phenomenon.'
b'Patients with an Oswestry Disability Index (ODI) score \\u2265 35.'
b'Patients with a Visual Analogue Scale (VAS) leg score \\u2265 40.'
b'Failed conservative treatment (physical therapy, bed rest, medications, spinal'
b'injections or transcutaneous electrical nerve stimulation) for a period of 6 months'
b'prior to study enrollment.'
b'Patients willing to undergo PK sampling.'

Exclusion Criteria

b'Patients with open epiphyseal plates.'
b'Patient requiring emergency spinal decompression or spinal fusion.'
b'Patients requiring multilevel fusion or expected to need secondary intervention within'
b'one year following surgery.'
b'Any prior fusion or attempted fusion at an adjacent level.'
b'Pregnant or breast-feeding women.'
b'Known or suspected allergies to any of the components of KUR-113 Bone Graft (e.g.'
b'hypersensitivity to aprotinin).'
b'Any prior use of teriparatide or abaloparatide or graft material containing PTH1-34.'
b'Patients with hypercalcemic disorders (e.g., primary hyperparathyroidism).'
b"Patients with Paget's Disease or unexplained high levels of alkaline phosphatase."
b'Prior radiation therapy involving bone.'
b"Medical history or radiographic evidence of a metabolic bone disorder (e.g. Paget's"
b'Disease) or other condition that would negatively impact the healing process.'
b'Any medical condition requiring radiotherapy or immunosuppression.'
b"History of thyroid autoimmune disease (Hashimoto's thyroiditis, Graves' disease) or"
b'hyperthyroidism.'
b'Patients on chronic systemic steroids (i.e. > 14 consecutive days) within 6 months'
b'prior to Screening Visit.'
b'Osteopenia (T score < -1.0) or osteoporosis of the spine (T score < - 2.5).'
b'DDD related to benign or malignant tumor.'
b'History or presence of active malignancy.'
b'Hereditary disorders predisposing to osteosarcoma.'
b'Patients with invasive skin cancer.'
b'Evidence of local or systemic infection.'
b'Patients with known active COVID-19 disease.'
b'Current smokers.'
b'Type 1 or Type 2 diabetes.'
b"Any acute or chronic concurrent medical conditions that in the Investigator's opinion"
b'are a contraindication to the procedure and study participation.'
b'Participation in another investigational study within 30 days prior to surgery for'
b'investigational devices, or within the last three months for investigational drugs.'
b'(Note: trials requiring extended follow-up for products that were investigational, but'
b'have since become commercially available, are not considered investigational trials).'
b'Known substance abuse, psychiatric disorder or a condition which, in the opinion of'
b'the investigator, may influence the healing or ability to comply with protocol'
b'requirements.'
b'Involved in active litigation relating to his/her spinal condition or workers'
b'compensation claimants.'
b'BMI greater than 40.'
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

bone graft
leg pain
conservative management
spondylolisthesis
disc disease
conservative therapy
autograft
bed rest
fibrin
conservative treatment
scarring
osteophyte
intervertebral disc degeneration

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.