Phase I/II clinical trial of NZ-C1909

JRCT ID: jRCT2031220509

Registered date:14/12/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Degenerative lumbar diseases
• Date of first enrollment: 22/12/2022
• Target sample size: 24
• Study type: Interventional
• Intervention(s): A lumbar interbody fusion is performed by filled NZ-C1909 or autologous bone into the spinal cage.

Outcome(s)

• Primary Outcome: Bone fusion by CT imaging evaluation at 52 weeks after surgery.

Secondary Outcome

1) Bone fusion by CT imaging evaluation at 12, 26, and 52 weeks after surgery.
2) Bone fusion by radiographic evaluation at 12, 18, 26, 39, and 52 weeks after surgery.
3) Change from baseline in VAS of back pain or and leg pain due to degenerative lumbar disease at 6, 12, 18, 26, 39, and 52 weeks after surgery.
4) Change from baseline in ODI at 6, 12, 18, 26, 39, and 52 weeks after surgery.
5) Change from baseline in JOABPEQ at 6, 12, 18, 26, 39, and 52 weeks after surgery.
6) Change from baseline in EQ-5D-5L at 6, 12, 18, 26, 39, and 52 weeks after surgery.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with back pain or leg pain due to lumbar degenerative disease and who are candidates for lumbar interbody fusion of single level.
2) Patients whose skeleton is sufficiently mature.
3) Patients who are at least 18 years of age at the time of consent, who are men and postmenopausal women (including menopause due to ovariectomy).
4) Patients who have been fully informed of the details of this clinical trial and have obtained their written consent.

Exclude criteria

1) Patients who have a history of spinal fusion surgery at the surgical site.
2) Patients with presence or history of malignancy.
3) Patients with autoimmune diseases.
4) Patients with active systemic infection or infection at the planned surgical site.
5) Patients with BMI >=30.
6)Patients with a history of smoking (including e-cigarettes) within 12 weeks of the date of consent.
7) Patients with the uncontrolled diabetes mellitus.
8)Patients with endocrine disorders or metabolic disorders known to affect bone metabolism.
9) Patients with a history of spinal surgery within the past 12 weeks from the date of surgery.
10) Patients who have administered drugs that may affect bone fusion within the past 4 weeks from the date of surgery.
11) Male patients whose partners wish to become pregnant or who are unable to use adequate contraception during the clinical trial period.

Related Information

• Primary Sponsor: Okawa Atsushi