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
Protocol serial number	Charité Projekt 88132022
Sponsor	Deutsche Arthrose Hilfe e.V. (Germany)
Funder	Deutsche Arthrose Hilfe e.V. (Germany)

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

Charité-Universitätsmedizin Berlin
Campus Benjamin Franklin
Hindenburgdamm 30
Berlin
12200
Germany

Phone	+49 (0)30 8445 2550
Email	olaf.suess@charite.de

Study information

Primary study design	Observational
Study design	International multicentre prospective single-arm observational surgical implant trial
Secondary study design	Cohort study
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.