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E�������j	j	�������������4d�y/�llll�sss�.�.�.�.�.�.�.$/1��3�.9��ss���.��l��3/�%�%�%�:�l���.�%��.�%�%�%l,����P��?������"��%�.I/0y/�%�4�$�4�%�%n�4�L*ts��%��sss�.�.�%sssy/�������������������������������������������������������������������������4sssssssssj	�:Total disc arthroplasty in treatment of lumbar spine degenerative pathology and outcome in 104 patients


Keyvan MOSTOFI 1, Robin SROUR2, 

   1 Department of Neurology/Neurosurgery, General Hospital of Cayenne, French Guiana, neurosurgeon consultant 

   2 Department of Neurosurgery, hospital Pasteur Colmar, France chief of department, neurosurgeon


Abstract
-----------------------------------------------------------------------------------------
Background
Lumber disc arthroplasty is one of the technological advances in the last decade in the treatment of lumbar degenerative pathology. Several studies have shown promising results in this surgery. The aim of this retrospective study is to establish the impact and outcomes of managing the patients with lumbar spine degenerative pathology and those who have been treated by lumbar Total Disc Arthroplasty (TDA).

Material and Method: we reviewed the files of 104 patients in department of Neurosurgery in Colmar (France) who had been operated on for lumbar spine arthroplasty (Prodisc) between April 2002 and October 2008.
Result: Of the 104 patients, 67 were female and 37 were male with an average age of 33.1. On average, we followed the cases up to 20 months. The most frequent level of discopathy was L4-L5 with 62P (59.6%) followed by L5-S1 level with 52 P (50%). 83 patients suffered from low back pain, 21 of which associated with radiculopathy. The condition of 82 patients improved after surgery according to Oswestry low back pain score and 77 patients could return to their work.

Conclusion:  The results from our study corroborate that TDA is a good alternative treatment for in lumbar spine degenerative pathology in particular with including patients with disabling and chronic low back pain. This technique contributes to improving a better living situation for the patients given the correct indications.













Keyword: low back pain; Spine surgery, degenerative pathologies lumbar vertebrae

Introduction

For a long time, there was a controversy in the surgical degenerative indication of treatment of the lumbar pathologies in particular chronic lumbago. Advances in the field of the lumbar spine surgery transformed the management of the degenerative pathologies lumbar vertebrae. Among these techniques, the total arthroplasty through anterior or anterolateral approach were widely exercised by different spinal surgeons in the last years [1-21]. Anterior approach allows a complete access to lumbar disc without touching paravertebral muscles and posterior facets which in return does not compromise biomechanical stability and functionality of posterior lumbar facets.  
In this paper, we present our experiences in Total disc arthroplasty in treatment of lumbar spine degenerative pathology and establish the impact and outcomes of this technique.

Materials and Methods

From April 2002 to October 2008, 104 patients underwent total disc arthroplasty (Prodisc) in department of Neurosurgery of Colmar in France. All the patients were included in the study. We studied the files of these patients retrospectively. In each patient, the case notes were reviewed to record clinical history examinations and radiological findings. The surgery was normally performed in these circumstances : lumbalgia caused by chronic and invalidating discopathy, resistant to a six month well led medical treatment in an adult below 60 carrying symptomatic discopathiy lumbar or lumbosacral discopathy without associated sciatica[1,3,7-9,11-13,15,17,20]. Patients have been evaluated in preoperative period. In postoperative period patients have been examined clinically two times(6 weeks and 12 weeks) and evaluated with visual analogue scale (VAS) that ranged from 0 (no pain) to 10 (worst pain imaginable) and with 0-100 Oswestry Disability Index (ODI). All patients had in 6th week an X-ray imaging of lumbar spine. Among these patients there were 21 patients who had undergone a lumbar spine surgery by posterior approach previously.

Surgical procedure
In 91 patients transperitoneal approach was performed and in 13 cases the anterior paramedian retroperitoneal approach was acted. In transperitoneal approach the position is Trendelenburg and a transverse incision is made in the skin and after muscle-splitting in peritoneum. Intraperitoneal organs are retracted. The prevertebral neurovascular structures( hypogastric nerve plexus, vena cava, aorta) are identified and posterior layer of peritoneum is opened. After meticulous dissection, the anterior longitudinal ligament and disk are incised and discectomy was performed. The posterior longitudinal ligament is preserved if possible and artificial disc is placed in the intervertebral disc space. In the anterior paramedian retroperitoneal approach, the incision is left paramedian oblique. The external oblique fascia and muscles are identified and opened and the rectus muscle is retracted. The peritoneum is dissected and retracted medially. Then psoas musle,left ureter, left iliac artery and vein are identified and retracted respectively. the rest of the procedure is similar to transperitoneal approach.




Results 

The patients comprised of 67 female and 37 male. The median age of the patients was 35.1 with 20 as the youngest and 58 as the oldest. There was an average follow up of 20 months (3 to 38 months)(Fig 1) 

. 
Fig1: Age distribution of patients 

21 patients had been operated on previously by posterior approach for different reasons including disc herniation or lumbar canal stenosis or other. We never intervened with surgery if the level had been instrumented previously. 83 patients (79.81 %) suffered from pure lumbago without radiculopathy, 21 patients (20.19 %) had associated radiculopathies.
All the patients benefited from an MRI of the lumbar spine at the stage of the diagnosis. In 22 patients we were obliged to resort to the discography because there were doubts on the sick level.
In 17 cases there was more than one sick disc with following information to know: 13 patient two levels and 4 patient three levels. (Tab1) 

Table 1- distribution of patient as number of sick disc
_____________________________________________________
		1 level			2 levels 			3 levels
________________________________________________________________
Patients No	87			13			4

In 9 patients, radiculopathy were being discordant with the level. The most frequent level of the sick disc was L4-L5 with 62 cases (59.62 %).
The level L5-S1 was in the second place  with 52 cases (50 %) Levels higher were much rarer with 7 cases (6.73%) in L3-L4 and L2-L3 with 4 case (3.85%)(Fig 2).


Fig2- Level distribution of patients as sick disc 

 87 patient (83.65%) harboured operation in one level 13 P. (12.50) in two levels and 3 patients (2.88%) harboured operation in three levels.
The MRI showed the following results: 43 patients had Modic sign 0, 43 patients had Modic sign I and 15 patients Modic II and 3 patients had Modic sign III.

All patients underwent preoperative computerized tomographic angiography to estimate vascular system of the region and AP and lateral lumbar spine radiograph and dynamic X-ray.

Table 2 Clinical and preoperative assessment data of patients

malefemalePLARIRMDGLRCTACOPLSPatient No�37678321104221041041221Mc 0�:43Mc I�:43Mc II�:15Mc III�:3*PL=pure lumbalgia; AR= Associated radiculopathy; Mc=Modic; DG=discography; R= lumbar radiograph; CTA= CT angiography, CO=complication; PLS=previous lumbar surgery

Average length of Stay in Hospital was 3.5 days with minimum of 2 and maximum of 15 days. The patients were ambulated the day one and from the first consultation they are authorized to take back y their activities.
We had the complications that we had summarized in Table 3.

Table 3- postoperative complications 
_______________________________________________________________
Complications 						number of patients (%)
_________________________________________________________________________________________________________________

 Retrograde ejaculation						2 (1.92%)

Urethral injury								2 (1.92%)

Wound dehiscence 							1 (0.96%)

Vaginal dryness 							2 (1.92%)

Retroperitoneal hematoma						1 (0.96%)

Prosthesis dislocation						1 (0.96%)

Abdominal wall hematoma						1 (0.96%)
_________________________________________________________________________________

Total 									10 (9.61%)


All of patient respond to visual analogue scale (VAS) and Low back pain Oswestry disability questionnaire (ODI) before and after intervention in immediate preoperative period and 6 weeks and 12 weeks after surgery. Table 4 summarizes the results of this evaluation in pre and post operative. All patients made improvement after 6 weeks except one patient who aggravated of one point on VAS 6 weeks later but returned on his preoperative situation 12 weeks later and 3 patients who did not improve on VAS. All the patients improved 6 weeks and then 12 week on ODI.




Table 4- preoperative and postoperative VAS and ODI

PreoperativePost op 6 weeksPost op 12 weeks   VASODIVASODIVASODI7.02(5-10)79.2(48-90)2.17(0-6)35.6(12-58)1.25 (0-5)24.1(06-32)*VAS= visual analogue scale; ODI= Oswestry Disability Index








Discussion


The treatment of lumbalgia was always problematic for specialists of spine. The surgical treatment was a controversy. According to Burke et al, lumbar degenerative disc diseases lead to mechanical instability that stimulates the appearance of nociceptives intradiscal fibers. By replacing the sick disc with an artificial disc, this source of pain will be deleted and mobility, disc height and segmental stability will be restored. The ProDisc was designed by T. Marnay in 1987 [3]. This technique afterward spread quickly in the world inciting several clinical trials especially in the USA. Numerous studies with positive results support this technique. The results of the current study demonstrate a satisfactory outcome with significant improvement of VAS and ODI. All the patients have been seen in control consultation in 6th and 12th week post operative with AP and lateral lumbar spine radiograph Among the 104 patients 51(49.03%) returned to their works within 6 weeks and 92(88.46%) within 12 weeks. 45 patients had dynamic X ray which confirm persistence of mobility section. After 12 weeks. Among 23 patients having had strenuous and regular sports activity 19 patients (82.6%) started their sport activity completely after 12 weeks Resort to hospitalization in medical physical and rehabilitation center was made in 4 cases. Before surgery the minimum of pain was 5 in VAS. 6 week after we had 36(34.62%) patients with zero pain (VAS =0) and 69 (66.35%) patients with VAS=0. Among the patients with radiculopathy, 17 became asymptomatic in spite of the fact that 9 patients had radiculopathy was clashing with the supposed sick level. Recently a study [9] suggests that the patients with radiculopathy non herniated may be suboptimal candidates for the procedure.

While other studies reported complication of between 1%-40% [1, 3, 7-9, 11-15, 17-21]. Our study showed relatively lower rate of complication: 10 (9.61%). This big variation can be explained in different studies by the use of various techniques and approach and the level of experience of the surgeons. In our case, 91 patients (87.5%), which is majority of cases, we used the transperitoneal approach and in 13 cases (12.5%) the anterior paramedian retroperitoneal approach. We have more experience in transperitoneal approach than retroperitoneal approach. We believe that during the retroperitoneal approach there is no a straight axis of vision and iliac artery and iliac vein (at left because this approach is usually made by the left side) must be retracted medially. We had to operate 4 patients (3.86%) for the complications (Table 2 and 3). There were a Wound dehiscence, a retroperitoneal hematoma, an abdominal wall hematoma and a prosthesis dislocation.
One of the most important complications met in scientific literature is major vessel injury with an incidence between1.9 to 2.9 % [5, 6]. We had one retroperitoneal hematoma (0.96%) The incidence of retrograde ejaculation is between 0 and 4.1% in the literature. We had 2 (1.92%)
The results obtained by our study are very promising especially in comparison with posterior fusion that the patients keep lumbago of multiple origins. A meta-analysis of artificial total disc replacement versus fusion for lumbar degenerative disc disease made by Yajun et al shows that total disc arthroplasty results in a slightly better functioning and back pain status and a significantly greater patient satisfaction. The follow up was 2 years. Another study made in South Korea [8] with 5-year follow up results shows 88% satisfied or somewhat satisfied patients. Our study gives the similar results with 86.54% satisfied and somewhat satisfied patients in 6th weeks and 87.5% in 12th week. Our average follow up of patients was 20 months (3 to 38 months).This relatively short duration of follow-up can be considered as an inconvenience but In our experience we noticed that the most important improvement are made in the first six weeks and the evolution becomes slower and more discreet.
In conclusion our study demonstrated satisfactory clinical and radiographic results and shows that this technique is valuable, simple and effective in treatment of lumbar degenerative pathology


















References 


1-Edgard-Rosa G, Geneste G, N�gre G, et al.Midline Anterior Approach from the Right Side to the Lumbar Spine for Interbody Fusion and Total Disc Replacement. A New Mobilization Technique of the Vena Cava.Spine (Phila Pa 1976). 2011 Oct 20
2-Zigler JE. Lumbar spine arthroplasty using the ProDisc II.Spine J. 2004 Nov-Dec;4(6 Suppl):260S-267S.
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4-Aoki Y, Ohtori S, Ino H, et al. Disc inflammation potentially promotes axonal regeneration of dorsal root ganglion neurons innervating lumbar intervertebral disc in rats. Spine 2004;29:2621-6.

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21-Zweig T, Hemmeler C, Aghayev E, et al. hijyz����G	_	`	b	k	�	�	
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