Prospective International multicentre Evaluation of Radiological and Clinical Effects of stand-alone polyetheretherketone (PEEK) intervertebral spacers for anterior cervical discectomy and fusion (ACDF)
| ISRCTN | ISRCTN42774128 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42774128 |
| Secondary identifying numbers | Charité Projekt 88132022 |
- Submission date
- 14/04/2009
- Registration date
- 22/04/2009
- Last edited
- 30/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Olaf Suess
Scientific
Scientific
Charité-Universitätsmedizin Berlin
Campus Benjamin Franklin
Hindenburgdamm 30
Berlin
12200
Germany
| Phone | +49 (0)30 8445 2550 |
|---|---|
| olaf.suess@charite.de |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | PIERCE-PEEK |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 356 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/01/2010 |
Locations
Countries of recruitment
- Argentina
- Cyprus
- Germany
- Türkiye
Study participating centre
Charité-Universitätsmedizin Berlin
Berlin
12200
Germany
12200
Germany
Sponsor information
Deutsche Arthrose Hilfe e.V. (Germany)
Research organisation
Research organisation
Postfach 11 05 51
Frankfurt am Main
60040
Germany
| Phone | +49 (0)6831 9466 77 |
|---|---|
| service@arthrose.de | |
| Website | http://www.arthrose.de |
"ROR" |
https://ror.org/05e1k0d14 |
Funders
Funder type
Research organisation
Deutsche Arthrose Hilfe e.V. (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/04/2017 | 30/12/2020 | Yes | No |
Editorial Notes
30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
