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

Not Applicable

Completed

• Conditions: Cervical degenerative disc disease; Musculoskeletal Diseases; Cervical disc disorders

• Registration Number: ISRCTN42774128
• Lead Sponsor: Deutsche Arthrose Hilfe e.V. (Germany)

Brief Summary

2017 results in https://pubmed.ncbi.nlm.nih.gov/28465721/ (added 30/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-22
• Study Completion: 2010-01-01
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 356

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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