Abstract
BackgroundWhen surgically treating cervical degenerative disc disease, the most commonly performed procedure is anterior cervical discectomy. This procedure is performed with, or without fusion promoting methods. For both options the rate of fusion is high and there is much debate whether fusion of the treated segment is a contributing factor to accelerated degeneration of adjacent motion segments. In an effort to prevent degeneration of adjacent segments (ASDeg) due to loss of mobility at the operated level, cervical disc arthroplasty (CDA) was introduced. To evaluate the effectiveness of CDA in preventing ASDeg long term studies are necessary. However, prevention of ASDeg is based on the premise that mobile disc prostheses preserve cervical spine motion in a physiological way. In this article the authors describe a short term protocol for a study that aims to investigate whether CDA reaches the intended goal: restoration or preservation of physiological cervical spine motion. To this end, a technique is used to establish the sequence of contributions of cervical motion segments to flexion/extension of the spine.Methods24 subjects between 18 and 55 years old, with radicular symptoms due to a herniated disc between C5 and C7, refractory to conservative therapy are randomized to simple discectomy, or CDA. These groups are preceded by a pilot group of three subjects receiving CDA. Fluoroscopic flexion-extension recordings are acquired preoperatively, and at three and 12 months postoperative. At these same time points, patient reported outcomes are collected, and a neurological examination is performed by and independent physician.DiscussionStudies investigating arthroplasty determine mobility by measuring segmental range of motion (sROM), which gives no information other than presence, and quantity, of mobility. SROM suffer from high variability. The authors therefore chose to use a method previously used in healthy controls, to describe the dynamic process of cervical spine motion in more detail. Determining cervical spine motion patterns has been reported to be more consistent than sROM. If a physiological motion pattern is absent after surgery in the CDA group, prevention of future ASDeg is less likely. Radiological outcomes will be correlated to clinical outcomes.Trial RegistrationNCT00868335Electronic supplementary materialThe online version of this article (doi:10.1186/s12891-015-0479-4) contains supplementary material, which is available to authorized users.
Highlights
When surgically treating cervical degenerative disc disease, the most commonly performed procedure is anterior cervical discectomy
Primary objective of the study is to ascertain whether a mobile cervical disc prosthesis restores/preserves the sequence of segmental contributions that is present in healthy controls, in contrast to patients undergoing simple discectomy
Secondary goal is to evaluate the clinical results of cervical disc arthroplasty (CDA) with the prosthesis used, compared to simple discectomy, to determine if results are comparable to reported results for this type of surgery
Summary
We include patients with a radiculopathy due to, MRI confirmed, single level soft disc herniation at the C5-C6 or C6-C7 level, refractory to at least 12 weeks of conservative treatment They must be able to actively make a full flexion to extension movement. Cervical spine X-rays are acquired the day after surgery and the wound drain is removed Patients in both groups are encouraged to mobilise, and resume home activities and work as soon as possible. – Absence or presence of normal sequence of segmental contributions to cervical spine movement, analysed through fluoroscopic flexion-extension recording (FFER). Clinical outcome measures At the same three time points at which the radiological analysis takes place the subject will be neurologically examined by an independent physician or physician assistant who is blinded to the treatment group. All data will be analysed according to the ‘intent-to-treat’ principle, a sensitivity analysis will be performed, based on presence or absence of fusion
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