Prospective International multicentre Evaluation of Radiological and Clinical Effects of stand-alone polyetheretherketone (PEEK) intervertebral spacers for anterior cervical discectomy and fusion (ACDF)

Prospective International multicentre Evaluation of Radiological and Clinical Effects of stand-alone polyetheretherketone (PEEK) intervertebral spacers for anterior cervical discectomy and fusion (ACDF): a prospective single-arm observational surgical implant trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN42774128

Enrollment

200

Registered

2009-04-22

Start date

2006-09-01

Completion date

Unknown

Last updated

2021-01-11

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

Conditions

Cervical degenerative disc disease Musculoskeletal Diseases Cervical disc disorders

Interventions

Single-level anterior cervical discectomy, as routinely performed in one of the five study centres. The surgeon is free to choose between four different PEEK cage intervertebral spacers. The cage size

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age greater than or equal to 18 years, either sex 2. Cervical degenerative disc disease at a single level, C3/C4 - C7/Th1 3. Clinical signs of myelopathy or radiculopathy 4. Presence of neck/arm pain (cervicobrachialgia) and/or radicular deficits, which are refractory to conservative therapy

Exclusion criteria

Exclusion criteria: 1. Unable to provide informed consent to surgery 2. Osteoporosis, fractures, or concomitant tumours of the cervical vertebrae 3. Previous surgery in the affected level 4. Fusion of either immediately adjacent level (due either to a previous operation or natural history) 5. Kyphosis or instability/hypermobility in functional x-rays (because this was taken as an indication for ventral plating) 6. Systemic, spinal, or local infection (acute or chronic) 7. Known allergies or intolerance to the implant material PEEK

Design outcomes

Primary

Measure	Time frame
1. Visual Analogue Scale (VAS) for patient-evaluated neck pain 2. Denis Pain Scale for clinician-evaluated neck pain 3. Neck Disability Index (NDI) for patient functioning 4. Japanese Orthopedic Association (JOA) questionnaire for assessment of neurological functioning Measured at time of discharge from hospital (mean: 3 - 7 days post-surgery); 6 months post-surgery and 12 months post-surgery.	—

Secondary

Measure	Time frame
1. Radiological assessment of bony fusion 2. Radiological assessment of proper implant placement versus subsidence or migration 3. Radiological assessment of adjacent-level degeneration and/or instability 4. Documentation of complications Measured at time of discharge from hospital (mean: 3 - 7 days post-surgery); 6 months post-surgery and 12 months post-surgery.	—

Countries

Argentina, Cyprus, Germany, Turkey

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026