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An autogenous controlled study of bone marrow enriched repair materials and autologous bone for unilateral decompression -TLIF

An autogenous controlled study of bone marrow enriched repair materials and autologous bone for unilateral decompression -TLIF

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064464
Enrollment
Unknown
Registered
2022-10-09
Start date
2022-11-10
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

lumbar degenerative disease

Interventions

Group A:Bone marrow enriched bone repair material was used as intervertebral bone graft material in upper vertebral space
Group B:Autologous bone was used as intervertebral bone graft material in upper vertebral space

Sponsors

Department of Orthopedics, the First Affiliated Hospital of Army Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with lumbar disc herniation, lumbar spinal stenosis, lumbar spondylolisthesis (I-II degrees) and other degenerative diseases of lumbar, who are ineffective after at least 1 month of conservative treatment, and have surgical indications of lumbar double level fusion; 2. Voluntarily take the test and sign informed consent; 3. No restriction on gender or age; 4. Good understanding and compliance, able to communicate well with researchers and comply with the whole test requirements.

Exclusion criteria

Exclusion criteria: 1. Systemic active infection; 2. Fever or abnormal blood pattern; 3. Suffering from mental illness; 4. Any potential conditions that may affect the effect of fusion implant implantation, such as malignant tumors, congenital malformations, surgical site fractures, and other underlying diseases; 5. Severe osteoporosis; 6. Previous history of severe allergy and rejection of medical materials; 7. The tissue coverage of the patient's surgical site was insufficient; 8. Patients participating in other clinical trials; 9. Other conditions considered inappropriate for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
Surgical segmental fusion rate;

Secondary

MeasureTime frame
Surgical segmental fusion time;Range of motion of the operative segment;Intraoperative complications;Visual analog pain scores;Oswestry disability index;

Countries

China

Contacts

Public ContactHou Tianyong
tianyonghou@126.com+86 15023253626

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026