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A prospective controlled clinical study on the treatment of lumbar degenerative diseases with a new type of allogeneic bone interbody fusion cage

A prospective controlled clinical study on the treatment of lumbar degenerative diseases with a new type of allogeneic bone interbody fusion cage

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075577
Enrollment
Unknown
Registered
2023-09-08
Start date
2020-06-07
Completion date
Unknown
Last updated
2023-09-11

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

Conditions

lumbar degenerative disease

Interventions

Experimental Group :Intervertebral fusion using allogeneic bone fusion cages
Control Group :Intervertebral fusion using PEEK material fusion cage

Sponsors

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

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Accept random selection of different intervertebral fusion cages in different intervertebral spaces, voluntarily participate and sign an informed consent form 2) Age 30-80 years old 3) Suffering from degenerative diseases such as lumbar disc herniation, lumbar spinal stenosis, and lumbar spondylolisthesis 4) Surgical indications for lumbar dual segment fusion surgery 5) Good understanding and compliance, able to communicate well with researchers and comply with the entire experimental requirements

Exclusion criteria

Exclusion criteria: 1)Active infection throughout the body 2) Obvious local inflammation 3) Fever or abnormal blood count 4) Suffering from mental illness 5) Any potential situation that may affect the effectiveness of fusion cage implantation, such as malignant tumors, congenital malformations, surgical site fractures, other underlying diseases, etc. 6) Any deformity that affects the process of bone shaping, including but not limited to severe osteoporosis, bone resorption, bone loss, and other metabolic disorders that affect the spine 7) Individuals who are prone to allergies or have abnormal physical conditions 8) Patients who do not have indications for fusion surgery or only require single segment fusion surgery 9) Insufficient tissue coverage of the patient's surgical site 10) Those with poor compliance who cannot be followed up on time 11) Patients participating in other clinical trials 12) Other situations that researchers believe are not suitable for enrollment

Design outcomes

Primary

MeasureTime frame
Surgical segmental fusion rate;Surgical segment intervertebral space height;Surgical segment intervertebral foramen height;Surgical segmental fusion cage settlement;Visual analog pain scores;Oswestry disability index;

Secondary

MeasureTime frame
Surgical segment;operative time;Surgical blood loss;Postoperative hospitalization time;

Countries

China

Contacts

Public ContactHou Tianyong

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

tianyonghou@126.com+86 150 2325 3626

Outcome results

None listed

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