Condition category
Musculoskeletal Diseases
Date applied
14/04/2009
Date assigned
22/04/2009
Last edited
22/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/09/2006

Overall trial end date

01/01/2010

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

200

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

Trial 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

http://www.arthrose.de

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes