Gore and Sepic examined 50 patients after anterior cervical fusion over a followup interval of 21 years. To assess clinically relevant adjacent segment degeneration after cervical fusion, Hilibrand et al. They reported a 2. These results led to the suggestion that adjacent segment degeneration was a result of the natural progression of cervical spondylosis, and not the result of the fusion.
Aetna considers lumbar prosthetic intervertebral discs e. Aetna considers lumbar partial disc prosthetics e. Aetna considers artificial cervical discs experimental and investigational for persons with prior disc replacement if the new request would result in more than 2 contiguous disc replacement levels from C3 to C7.
Aetna considers artificial cervical discs experimental and investigational for persons with prior fusion or surgery at an adjacent cervical spine level. Background Artificial intervertebral disc replacement is an alternative to cervical and lumbar spinal fusion surgery for those individuals suffering from back or neck pain due to degenerative disc disease DDD.
The artificial disc was designed to restore normal disc height, to preserve the spinal flexibility and decrease degeneration of adjacent discs, which can occur as a result of DDD. Since the s, investigators have been working on developing an artificial prosthetic intervertebral disc IVD that can be used to replace degenerated intervertebral discs Diwan et al, Most of the published clinical evidence for artificial prosthetic intervertebral discs has been of those that replace the entire disc.
The major potential advantage of a prosthetic intervertebral disc over current therapies for degenerated disks such as spinal fusion or diskectomy is that the prosthetic intervertebral disk is intended to restore or preserve the natural biomechanics of the intervertebral segment and to reduce further degeneration of adjacent levels.
The Charite Artificial Disc: The patients were evaluated with plain radiography, some with flexion-extension x-rays, and most of them with computed tomography scans. The group consisted of 15 women and 12 men.
Their mean age was 40 years range, 30 - 67 years at the time of operation.
The patients presented to the investigators a mean of 53 months range 11 - months following disc replacement surgery. In two patients, an early removal of a prosthesis was required and in two patients a late removal. In 11 patients, a second spinal reconstructive salvage procedure was performed.
Mean follow-up for 26 patients with mid- and long-term evaluation was 91 months range 15 - months. Early complications were the following: In one patient, an anterior luxation of the prosthesis after 1 week necessitated removal and cage insertion, which failed to unite.
In another patient with prostheses at L4 - L5 and L5 - S1, the prosthesis at L5 - S1 dislocated anteriorly after 3 months and was removed after 12 months. Abdominal wall hematoma occurred in four cases. Retrograde ejaculation with loss of libido was seen in one case and erection weakness in another case.
A temporary benefit was experienced by 12 patients, while 14 patients reported no benefit at all. Main causes of persistent complaints were degeneration at another level in 14, subsidence of the prosthesis in 16, and facet joint arthrosis in A combination of pathologies was often present.
Slow anterior migration was present in two cases, with compression on the iliac vessels in one case. Polyethylene wear was obvious in one patient 12 years after operation.
In eight cases, posterior fusion with pedicle screws was required. In two cases, the prosthesis was removed and the segment was circumferentially fused. These procedures resulted in suboptimal long-term results. In this relatively small group of patients operated on with a Charite disc prosthesis, most problems arose from degeneration of other lumbar discs, facet joint arthrosis at the same or other levels, and subsidence of the prosthesis.
Caspi et al reported results of lumbar disk prosthesis Charite after a follow-up period of 48 months. Poor results were reported by four patients, one of whom underwent postero-lateral fusion and another is waiting for the same operation.
There were two dislocations of the prosthesis followed by immediate revision surgery. The authors concluded that contraindications for surgery appear to be the principal cause of failure rather than the prosthesis itself.
The authors found that the neurological status was equivalent between the two groups at 6, 12, and 24 months, post-operatively. They concluded that the Charite intervertebral disc is safe and effective for the treatment of single-level degenerative disc disease, resulting in no higher incidence of neurological complications compared with BAK-assisted fusion, and leading to equivalent or better outcomes as indicated by visual analog scale and Oswestry Disability Index scores compared with fusion with those obtained in the control group and those reported in the lumbar fusion literature.
The authors concluded that the findings of this study is promising, but that longer follow-up is needed to determine the durability of the Charite artificial disc and its long-term safety and effectiveness.
The indications for the Charite define DDD as discogenic back pain with degeneration of the disc that is confirmed by patient history and radiographic studies. According to the FDA-approved labeling, these DDD patients should have no more than 3 mm of spondylolisthesis at the involved level.
The FDA approved labeling states that patients receiving the Charite Artificial Disc should have failed at least six months of conservative treatment prior to implantation of the Charite Artificial Disc.
The Charite Artificial Disc was approved by the FDA based on a clinical trial comparing the device to anterior lumbar interbody fusion ALIF with BAK cages filled with iliac crest autograft in subjects with symptomatic single level degenerative disc disease from L4 to S1 who had failed at least 6 months of conservative management.
The purpose of the study was to demonstrate the non-inferiority of the Charite Artificial Disc to an interbody fusion system. A total of patients were enrolled in the study using a 2:The BRYAN® Cervical Disc is a cervical disc replacement device comprised of the following components: two titanium shells, two titanium retaining wires, a polycarbonate polyurethane nucleus, a polyether polyurethane sheath, and two titanium seal plugs.
The articulating surfaces of the device are. PHYSIODISC is a cervical disc prosthesis made out of cobalt, This innovative cervical disc prothesis is distinguished by a maximum of mobility and fixation abilities.
It's anatomically formed design complies precisely to the natural shape of the /5(8). Cervical Prosthetic Discs (e.g., the Bryan Cervical Disc, the MOBI-C, the Prestige Cervical Disc, and the Secure-C Artificial Cervical Disc): Acosta and Ames () noted that cervical disc arthroplasty is a relatively new motion-preserving technique for the treatment of symptomatic DDD of the cervical spine.
The Bryan cervical artificial disc is unique in that there is a flexible membrane that surrounds the nucleus (the inner portion of the disc) that is filled with a lubricant. This membrane is designed for two purposes: to contain any wear debris that forms and to prevent any soft tissue in-growth.
The Bryan® cervical disc prosthesis is at the forefront of cervical arthroplasty and is available today. However, many questions about cervical disc replacement remain to be answered and include the effect to adjacent spinal levels and the device's longevity.
Jul 17, · The incidence of cervical disc degeneration after ACDF fusion has been studied extensively. Chen C, Zhang Y, Wang Z, Wang B, et al.
Randomized, controlled, multicenter, clinical trial comparing Bryan cervical disc arthroplasty with anterior cervical decompression and fusion in China. Spine. ; –8.