The Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication

Intermittent Neurogenic Claudication (INC) is a complex of symptoms first described by Van Gelderen in 1948 and in 1950 by the Dutch neurosurgeon Verbiest, therefore formerly known as the Verbiest syndrome [1‐4]. The characteristic symptom is described as leg pain (frequently in both legs) which can be exacerbated with prolonged walking or lumbar extension. Others, like Evans, describe a cramp, tightness or discomfort of the legs after walking which diminish after a short period of sitting or bending forward [1]. Apart from the leg pain, associated low back pain may occur [5].

Since the description of neurogenic claudication by Verbiest, explanation of the symptoms has been disputed. Verbiest stated in 1954: "In the writer's humble opinion the ligamentum flavum is most unlikely to contact any spinal root unless this root is distorted from its regular path"[4]. Evans showed in 1964 a cerebral spinal fluid stop at the low lumbar levels narrowing of the canal by degenerative facet arthrosis resulting in nerve root compression. INC is often seen in patients with lumbar degenerative spinal stenosis [4]. Due to this arthrosis of the facet joints, lumbar nerve root compression will develop. Arnoldi described multiple types of lumbar spinal stenosis. His article published in 1975 was actually a summarization of a symposium on this subject [4, 6]. Presently, his classification is still widely used. Like in any acquired disease, INC is usually seen in the elderly [1].

The best treatment of NIC due to lumbal stenosis remains controversial [5, 7]. Nonoperative therapy like epidural steroid injections, nonsteroidal anti-inflammatory medication, analgesics, physical therapy, and spinal manipulation, is frequently performed [8]. A 2005 Cochrane review found that the paucity and heterogeneity of evidence limited conclusions regarding surgical efficacy for spinal stenosis [7, 9‐12]. Indeed, Weinstein et al published in his article the results of a randomized cohort study with relatively poor results in the non-operative group [13‐15]. Despite the high level of crossovers in their study, the treatment effect was favoring surgery on the SF-36 scale for bodily pain. Also Malmivaara et al showed a better recovery after surgery versus conservative treatment with a difference of improvement of 11.3 on the ODI disability scale [16]. Furthermore Turner et al published in their attempted meta-analysis a success rate (good to fair outcome) of 64% after surgical bony decompression in patients with INC [17].

Thomé et al prospectively compared the most typically used techniques: laminectomy, unilateral laminotomy and bilateral laminotomy [18]. In the series of Thomé et al, bilateral laminotomy achieved an 80% success rate. It was slightly better compared to laminectomy, which had 70% success rate [18]. Many authors claim that bony decompressive surgery might facilitate spinal fusion in the future [19, 20]. Furthermore, local trauma in these surgical strategies should not be underestimated [21]. The above described operations are usually performed under general or local anaesthesia and 2 to 7 days hospitalization may be required, followed by an 8-weeks recovery period. Furthermore, the clinical outcome seems disappointing, since 35% of the patients documented bad outcome [13‐17].

Minimally invasive surgery has gained popularity in recent years, resulting in the development of interspinous implants in the 1980s [22]. One of these models, the Wallis device, was made with a band around the spinous processes. Later in 2003 X-stop, in 2005 Diam, in 2006 Coflex, and afterwards various other kinds of forms were developed to stabilize or distract the interspinous distance [23‐33]. These implants are all placed between spinous processes, which will lead to distraction of the interspace with consequent indirect decompression of the nerve roots. Presently, most publications refer to X-stop implants [8, 23‐26, 29‐31, 34‐36]. It is claimed that this indirect decompression will reduce the pressure on the nerves leading to a return to a neutral or slightly tightened position of the vertebral column. Nevertheless, this is a far smaller operation and gives perhaps less destruction to the bony elements of the vertebral column. Therefore, IPD is believed to have better short-term recovery and similar long-term (cost-) effectiveness [8, 34, 36, 37]. Outcomes were reported to be quite favorable in selected series of poor methodological quality. The first randomized multicentre study on interspinous devices compared X-stop with non-surgical treatment [36]. After 2 years, the IPD group shows both clinically and statistically significant improved results in comparison with the conservative treated group [8, 36]. However, this trial only compared IPD with conservative treatment. Good evidence on IPD versus other surgical treatment is not yet available. Verhoof et al reported in 2008 a high failure rate in IPD (X-stop), with an average slip on the radiographs of 19.6%, and a high surgical re-intervention rate (seven out of the 12) [35]. Strömqvist reported 13 re-operations in a group of 50 patients [38]. Park et al published one of the few studies with the Coflex implant [39]. However they only placed a Coflex implant after bony decompression [40]. Furthermore long term results, despite from the small retrospective series (twenty patients) of Kondrashov et al, are not yet available [34].

The golden standard in surgical treatment for lumbar spinal stenosis is bony decompression to which all new techniques should be compared. The purpose of our study is to asses whether IPD-surgery is more (cost) effective compared with surgical decompression in patients with INC due to lumbar stenosis. It is hypothesized that IPD gives particularly a favorable short term effect, necessitating a short term evaluation.

An observer and patient blinded randomized (cost-)effectiveness trial in the treatment of lumbar spinal stenosis is presented. In this trial two surgical techniques are compared in a parallel group design. The primary outcome measurement is the Zurich Claudication Questionnaire. The follow-up period will last 1 year. In order to collect enough patients, a multi-center design is necessary. The study protocol was approved in all participating hospitals (see table 1: list of hospitals).

Our primary question is whether IPD-surgery is more (cost-)effective compared with surgical decompression after 8 weeks in people with intermittent neurogenic claudication due to lumbar stenosis. The main advantage of IPD might be a faster recovery after surgery, but after long term follow-up it is unknown if this treatment effect will remain. Therefore, in addition, long-term follow-up (one year) will be compared with short-term follow-up.

In this article a design of a RCT is presented which evaluates the (cost-) effectiveness of IPD versus decompression surgery in the treatment of intermittent neurogenic claudication. This is the first randomized prospective trial comparing these two surgical techniques. Like the Sciatica-MED trial, the research nurse and the patient are blinded for the allocated treatment [7]. The objective of this trial is to determine whether the IPD is more (cost-) effective after eight weeks compared to the conventional decompression surgery.