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Efficacy of Minimally Invasive Transforaminal Lumbar Interbody Fusion plus Cement-Augmented pedicle Screw Fixation in the Treatment of Degenerative Lumbar Spine Disease with Osteoporosis in the Elderly

Efficacy of Minimally Invasive Transforaminal Lumbar Interbody Fusion plus Cement-Augmented pedicle Screw Fixation in the Treatment of Degenerative Lumbar Spine Disease with Osteoporosis in the Elderly

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072723
Enrollment
Unknown
Registered
2023-06-22
Start date
2020-02-04
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Lumbar Spine Disease with Osteoporosis

Interventions

A group:MIS-TLIF plus cement-augmented pedicle screw fixation
B group:TLIF plus cement augmentation

Sponsors

Department of Spinal Surgery, Lianyungang First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
61 Years to 81 Years

Inclusion criteria

Inclusion criteria: ? patients aged = 60 years; ? with low back pain or/and unilateral neurological symptoms with ineffective regular conservative treatment for 3-6 months; ? imaging: radiographs suggest intervertebral foraminal stenosis, lumbar instability, lumbar slippage (I°, II°), CT and MRI suggest changes such as nerve root and spinal cord compression; ? BMD =-2.5 SD; ? with imaging and physical examination suggesting single-segment lesions; ? who signed the medical ethics agreement.

Exclusion criteria

Exclusion criteria: ? patients aged <60 years; ? with imaging findings incompatible with physical examinations; ? with signs or imaging suggestive of =2 segmental lumbar spine lesions, severe scoliosis, or slippage above II°; ? with bilateral neurological symptoms; ? who were unable to receive surgical treatment; ? with severe osteoporosis (BMD =-2.5 SD, with fracture); ? with other spinal diseases.

Design outcomes

Primary

MeasureTime frame
The visual analogue scale (VAS) ,ODI and JOA scores before surgery, at 3 months, 6 months, and at the final follow-up visit of these two groups.;Fusion device situation;ODI scores;JOA scores;

Secondary

MeasureTime frame
intraoperative bleeding;Operation Duration;postoperative drainage;

Countries

China

Contacts

Public ContactRujie Qin

Lianyungang First People's Hospital

qinrjlyg@163.com+86 189 6132 2926

Outcome results

None listed

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