Feasibility study of cellular titanium cages in lumbar spondylodesis using posterolateral interbody fusion procedure

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20071

Enrollment

Registered

2017-11-29

Start date

2018-01-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Patients with lumbar spondylosis requiring a posterior spinal fusion with PLIF procedure.

Interventions

Posterolateral interbody fusion surgery

Eligibility

Inclusion criteria

Inclusion criteria: - Posterior spinal fusion with PLIF procedure (L2-S1), maximal 2 levels - Aged between 25 and 75 years - Chronic low back pain with or without leg pain - Failed conservative treatment at least six months prior to the posterior spinal fusion - Willingness to participate - Able to read and speak Dutch

Exclusion criteria

Exclusion criteria: - Previous lumbar fusion at the same level - Smoking - BMI >30 - Osteoporosis - Active, local or systemic infection (rheumatoid arthritis, spondylitis, previous spinal infections, previous spinal trauma) - Physical, emotional, neurological comorbidities intervening with the compliance monitoring (drug or alcohol abuse, mental illness, general neurological disorders such as Parkinson's, Multiple Sclerosis) - Oncological or hematological disorders

Design outcomes

Primary

Measure	Time frame
Bone ingroth in cages assessed on CT with bony bridging score	—

Secondary

Measure	Time frame
Functional status, quality of life, pain intenstity in beack and leg, satisfaction Adverse evants: e.g. complications, re-operation	—

Contacts

Public ContactMiranda van Hooff

Sint Maartenskliniek

m.vanhooff@maartenskliniek.nl024 365 9912

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)