Documentation of the patients' functional recovery and quantification of fusion after implantation of 3-D trabecular titanium cages on the short and long term. These data will be compared with the recently performed randomized CASCADE trial on…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is improvement in the Neck and Disability Index
(NDI) one year after surgery.
Secondary outcome
Secondary outcome measure is the temporal evaluation of bony fusion using
dynamic lateral flexion-extension radiographs that will be quantitatively
analysed. Other outcome measures include improvement in arm pain and neck pain
(VAS), EuroQol-5D, patients' perceived recovery, and perioperative variables
including operating time, blood loss, length of hospital stay, and adverse
events.
Background summary
Anterior cervical discectomy is the basic surgical treatment for patients with
radicular pain caused by cervical disc herniation unresponsive to conservative
treatment. At present, anterior cervical discectomy and interbody fusion with a
Polyetheretherketone (PEEK) plastic cage is considered as the golden standard,
although PEEK is a bio-inert material generating peri-implant fibrosis. In a
recent randomized controlled trial (CASCADE trial), PEEK has been compared to
ceramic cages. Currently, biocompatible porous 3-D printed titanium has become
available in spinal implants. In-vitro and in-vivo studies using porous 3-D
printed titanium implants in various animal species, have demonstrated high
osteo-integrative and fusion capacity, although clinical comparative studies
have not been conducted yet.
Study objective
Documentation of the patients' functional recovery and quantification of fusion
after implantation of 3-D trabecular titanium cages on the short and long term.
These data will be compared with the recently performed randomized CASCADE
trial on cervical cages. Whether porous titanium cervical cages have more
favourable clinical and radiological results as compared to the golden
standard, has to be determined by this trial.
Study design
The EFFECT study is designed as a prospective consecutive cohort trial, with a
total follow-up period of 1 year.
Intervention
Anterior cervical discectomy with interbody fusion by implantation of 3-D
trabecular titanium cage (EIT Cellular Titanium®).
Study burden and risks
Besides the known complications of an anterior cervical approach, there are
implant related risks like displacement, subsidence,
or breakage. The outpatient control will be more frequently than usual and
patients are asked to fill out several questionnaires.
Heubergweg 8
Tuttlingen 78532
NL
Heubergweg 8
Tuttlingen 78532
NL
Listed location countries
Age
Inclusion criteria
* Age 18 75 years.
* Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of myelopathy.
* At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication).
* Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms.
* Written informed consent.
Exclusion criteria
* Previous cervical surgery (either anterior or posterior)
* Increased motion on dynamic studies (> 3 mm)
* Neck pain only (without radicular or medullary symptoms)
* Infection
* Osteoporosis
* Neoplasma or trauma of the cervical spine
* Spinal anomaly (Klippel Feil, Bechterew, OPLL)
* Severe mental or psychiatric disorder
* Inadequate Dutch language
* Planned (e)migration abroad in the year after inclusion
. Pregnancy
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51781.098.14 |