Multicentre, prospective, randomised clinical survey to evaluate early fusion rate after instrumented lumbar stabilization with either MectaLIF PEEK lumbar cage or MectaLIF TiPEEK lumbar cage

Multicentre, prospective, randomised clinical survey to evaluate early fusion rate after instrumented lumbar stabilization with either MectaLIF PEEK lumbar cage or MectaLIF TiPEEK lumbar cage - Study to evaluate early fusion rate using MectaLIF PEEK or MectaLIF TiPEEK lumbar cage

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027744

Enrollment

240

Registered

2017-06-15

Start date

2017-10-01

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

Disorders that are treated with lumbar intervertebral body fusion, such as lumbar spondylolisthesis

Interventions

MectaLIF PEEK Cage (Oblique or Posterior Cage) - Depending on the patient, cages will be implanted into 1 or 2 intervertebral levels. -In general, the Oblique cage will be implanted. But if a cage

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients requiring lumbar intervertebral body fusion (according to the label indication/contraindications). - Patients requiring one or two-level fusion (level under evaluation L3-L4/L4-L5/L5-S1). - Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained when indication to surgery is confirmed. - Patients showing a level of Bone Mineral Density higher than 70% YAM on both vertebrae adjacent to each index level.

Exclusion criteria

Exclusion criteria: - Patients with metabolic bone diseases, use of steroids or other drugs affecting bone metabolism. - Patients who are currently taking teriparatide or denosumab. - Patients who have taken teriparatide within 1 month. - Patients who have taken denosumab within 6 months. - Patients with neuromuscular disorders such as Parkinson's disease or athetosis. - Patients who are on dialysis. - Patients with previous spine surgeries at the level, excepting those who underwent decompression and/or nucleotomies. - Patients with restricted mobility. - Patients who are deemed unfit for participation by the Principal Investigator or the Sub-Investigators.

Design outcomes

Primary

Measure	Time frame
Thin-slice CT to assess fusion rate and cage subsidence	—

Secondary

Measure	Time frame
- Clinical and functional assessment of the involved hip according to the ODI Index, VAS pain and JOA Back Pain Evaluation Questionnaire - Flexion/extension x-rays for functional assessment - Standard AP and lateral x-rays - CT Scan - Full spinal column X rays - MRI - Recording of Adverse Events	—

Countries

Japan

Contacts

Public ContactMorio Matsumoto

Keio University Hospital Department of orthopaedic surgery

morio@keio.co.jp03-3353-1211

Outcome results

None listed

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