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Clinical investigation to examine the bone fusion by using PEEK interbody cage or titanium coated PEEK interbody cage for posterior lumbar interbody fusion, a multicenter, randomized, open-label, parallel-group trial

Clinical investigation to examine the bone fusion by using PEEK interbody cage or titanium coated PEEK interbody cage for posterior lumbar interbody fusion, a multicenter, randomized, open-label, parallel-group trial - Clinical investigation to examine the bone fusion by using PEEK interbody cage or titanium coated PEEK interbody cage

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022618
Enrollment
150
Registered
2016-06-06
Start date
2016-06-06
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 canal stenosis, lumbar disc herniation, lumbar radiculopathy, spondylosis, spondylolisthesis, lumbar kyphoscoliosis, lumbar scoliosis, and lumbar kyphosis which need posterior interbody fusion

Interventions

We perform posterior lumbar interbody fusion with PEEK interbody cage. We perform posterior lumbar interbody fusion with titanium coated PEEK interbody cage.

Sponsors

Department of Orthopaedic Surgery, Hamamatsu University School of Medicine
Lead Sponsor
Fujiyoshida Municipal Hospital Enshu Hospita Hamamatsu Sekijuji Hospital Iwata City Hospital Jyuzen Memorial Hospital Hamamatsu Medical Center Narita Memorial Hospital Fujieda municipal General Hospital Fujinomiya City General Hospital Kikugawa General Hospital Shizuoka municipal Hospital Shinonoi General Hospital North Alps Medical center Azumi Hospital Ina Central Hospital Suwa sekijuji Hospital Yamanashi Prefectural Central Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who are eligilble for one level spinal fusion surgery for having lumbar degenerative disease (Lumbar canal stenosis, lumbar disc herniation, lumbar radiculopathy, spondylosis, spondylolisthesis, lumbar kyphoscoliosis, lumbar scoliosis, and lumbar kyphosis) 2. Patients 20 years of age or older at the time of signing consent form

Exclusion criteria

Exclusion criteria: 1.Patients 19 years of age or younger at the time of signing consent form 2.Patients whom the attending physician investigator has determined to be unsuitable for the conduct of the study.

Design outcomes

Primary

MeasureTime frame
By X-ray or CT image at 2M,4M,6M,9M and 12M after surgery 1.Fusion rate 2.Rate of intervertebral disc narrowing and instability 3.Occurrence rate of screw loosening—

Secondary

MeasureTime frame
Improvement of ADL and QOL—

Countries

Japan

Contacts

Public ContactTomohiko Hasegawa

Hamamatsu University School of Medicine Department of Orthopaedic Surgery

titan@hama-med.ac.jp053-435-2299

Outcome results

None listed

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