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Comparison of the PEEK cage and an autologous cage in posterior lumbar interbody fusion

Comparison of the PEEK cage and an autologous cage made from the lumbar spinous process and laminae in posterior lumbar interbody fusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN25558534
Enrollment
69
Registered
2016-02-16
Start date
2008-12-03
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Lumbar degenerative disc disease. Musculoskeletal Diseases

Interventions

Patients with lumbar degenerative disc disease were randomly assigned to either a PEEK (polyetheretherketone) cage or an autologous cage using the lumbar spinous process and laminae (ACSP). Monosegmen

Sponsors

Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged between 30-70 years 2. Disc pathology requiring surgical intervention for decompression 3. One intended level of interbody fusion between L3 and S1 4. Radiological evidence of instability, spondylolisthesis and the presence of degenerative stenosis, or symptomatic degenerative disc disease 5. Persistent or recurrent low back or leg pain lasting at least 6 months and resulting in a significant reduction of quality of life

Exclusion criteria

Exclusion criteria: 1. Patients need for two or more levels of fusion 2. Active infection 3. Metabolic disease 4. Severe osteoporosis, symptomatic vascular disease 5. Previous spinal surgery other than a lumbar discectomy in L3-L4, L4-L5, or L5-S1 6. Any major psychological problem 7. The combination of degenerative scoliosis and degenerative or isthmic spondylolithesis 8. Morbid obesity 9. Smokers

Design outcomes

Primary

MeasureTime frame
Functional outcome was assessed using the Kirkaldy–Willis criteria 3, 6, 12 and 24 months postoperatively and annually thereafter.

Secondary

MeasureTime frame
1. Visual Analogue Score (VAS) was obtained for low back pain both pre- and postoperatively at 2-year follow-up 2. Radiological assessment was recorded at at 3, 6, 12 and 24 months postoperatively and annually thereafter 3. Fusion status was evaluated by anteroposterior and lateral flexion and extension radiographs

Countries

China

Contacts

Public ContactBin Lin

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026