Study Evaluating CK2-092 as Bone Filling Material

Study Evaluating Self-Assembling Peptide gel CK2-092 as Bone Filling Material during Posterior Lumbar Interbody Fusion

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080225084

Enrollment

Registered

2020-02-25

Start date

2020-03-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lumbar spinal stenosis or spondylolisthesis

Interventions

investigational material(s) Generic name etc : CK2-092(bone filling material) INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational ma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have been diagnosed with either lumbar spinal stenosis or spondylolisthesis requiring PLIF

Exclusion criteria

Exclusion criteria: [1] has active malignancy [2] has coagulation disorder [3] has serious complication [4] receiving second surgery to the same lumbar level [5] BMI 40 or greater [6] current treatment with romosozumab or teriparatide, etc.

Design outcomes

Primary

Measure	Time frame
efficacy Bone fusion status at the site of autologous bone fragment grafting at postoperative month 12	—

Secondary

Measure	Time frame
safety efficacy [1] Postoperative QOL [2] Survey of the usability of investigational device [3] Change in bone fusion rate at the site of autologous bone fragment grafting [4] Adverse events [5] Medical Device Malfunction, etc.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026