Contact information
Type
Scientific
Contact name
Dr Olaf Suess
ORCID ID
Contact details
Charité-Universitätsmedizin Berlin
Campus Benjamin Franklin
Hindenburgdamm 30
Berlin
12200
Germany
+49 (0)30 8445 2550
olaf.suess@charite.de
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
Charité Projekt 88132022
Study information
Scientific title
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
Acronym
PIERCE-PEEK
Study hypothesis
The study explores the following questions about the use of stand-alone polyetheretherketone (PEEK) cages in anterior cervical discectomy and fusion (ACDF) for patients with single-level cervical degenerative disc disease:
1. How much clinical improvement is there, in terms of pain and functioning, at 6- and 12-month follow-up?
2. What is the rate of radiological fusion at the operated level and how well does this correlate with clinical improvement?
3. What is the rate of short-term surgical revision (cage explantation, implant replacement, secondary ventral plating and/or additional dorsal stabilisation) due to implant subsidence or migration or device-related complications?
4. What is the rate and degree of adjacent-segment instability at the 1-year follow-up?
5. Do any particular patient characteristics (sociodemographic, clinical) or surgical factors predict better or worse clinical outcomes?
Ethics approval(s)
Ethics Committee of Charité-Universitätsmedizin Berlin approved on the 22nd May 2006
Study design
International multicentre prospective single-arm observational surgical implant trial
Primary study design
Observational
Secondary study design
Cohort study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cervical degenerative disc disease
Intervention
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 is selected according to the pre-existing intervertebral space height. Cages are implanted without any filling or supplemental instrumentation. The patients were mobilised immediately post-surgery and did not receive a neck collar.
Intervention type
Other
Primary outcome measure
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 outcome measures
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.
Overall study start date
01/09/2006
Overall study end date
01/01/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
200
Total final enrolment
356
Participant 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
Recruitment start date
01/09/2006
Recruitment end date
01/01/2010
Locations
Countries of recruitment
Argentina, Cyprus, Germany, Turkey
Study participating centre
Charité-Universitätsmedizin Berlin
Berlin
12200
Germany
Sponsor information
Organisation
Deutsche Arthrose Hilfe e.V. (Germany)
Sponsor details
Postfach 11 05 51
Frankfurt am Main
60040
Germany
+49 (0)6831 9466 77
service@arthrose.de
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
Deutsche Arthrose Hilfe e.V. (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/04/2017 | 30/12/2020 | Yes | No |