Interbody fusion in the treatment of cervicobrachial syndrome; a prospective 5-year follow up extension study of porous titanium cervical cages

Interbody fusion in the treatment of cervicobrachial syndrome; a prospective 5-year follow up extension study of porous titanium cervical cages - The EFFECT extension trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50926

Enrollment

Registered

2021-06-10

Start date

2022-03-01

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

cervical herniated disc

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Subject must have completed participation in the EFFECT trial • Ability and willingness to comply with study requirements • Written informed consent given by the subject or the subject's legally authorized representati

Exclusion criteria

Exclusion criteria: • Severe mental or psychiatric disorder • Inadequate Dutch language

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is improvement in the Neck and Disability Index (NDI) 5 years after surgery.	—

Secondary

Measure	Time frame
Secondary outcome measure is the longterm evaluation of bony fusion using dynamic lateral flexion-extension radiographs that will be quantitatively analysed. Other outcome measures include improvement in arm pain and neck pain (VAS), EuroQol-5D and patients' perceived recovery 5 years after surgery.	—

Countries

Netherlands

Outcome results