Vol.14 /No: 2/ Nov 2005

 

   

 

 

Hybrid Lumbar Fusion:
A clinical and radiological review at 2 years

*Dyson P., **Abuhadra K., *Warren M.
*The Luton and Dunstable Hospital, Luton Bedfordshire, England
**Orthopedic Section, Surgery Department, Hamad Medical Corporation, Doha, Qatar
 

Abstract
Introduction
Patients and Methods
Results
Discussion
References 


Abstract:

We report on our first 20 patients treated with hybrid lower lumbar stabilization, in which one or more segments were treated with caged interbody fusion by PLIF technique and one or more adjacent segments were stabilized using GRAF instrumentation.

The indications for interbody fusion included spondylolysis; previous failed disc surgery, and primary discopathy with positive discography and/or active modic signal on MRI.

The indication for flexible stabilization of adjacent segments was for disc degeneration on MRI scanning with or without evidence of posterior annular tear.

This was a prospective study with clinical evaluation using VAS pain scales and Oswestry disability score. All patients were reviewed by an independent consultant radiologist to assess integrity of the implant after two years and underwent CT scanning to assess progression of the caged fusion. There were no instances of failed fusion in this group and no cases of implant failure.


Introduction:

The clinical outcomes of flexible lumbar stabilization using the GRAF method have been reviewed by Gardner(1,2) who has reported clinical improvement in 70% of cases of symptomatic lumbar disc degeneration. Our own experience has been similar, and has confirmed certain contra-indications for flexible stabilization.

1. GRAF stabilization has never been recommended for spondylolisthesis.

2. Success rates below 50% have been reported in revision cases.

3. The result in patients with Modic changes in the adja- cent end plates are inferior to those reported with inter- body fusion.

We therefore recommend interbody fusion rather than GRAF stabilization where surgery is undertaken for the above indications.

The assessment of interbody fusion remains confounded by the fact that clinical outcomes do not correlate well with successful radiological fusion. Failed radiological fusion, however, remains an unsatisfactory outcome for patients and their surgeons, and it is recognised that this is increasingly likely to occur according to the number of levels operated. Agazzi S, Reverdin A et al report successful fusion in 98% of cases at one level, 90% at two levels, and only 70% at three levels(3).

Gardner has reported excellent outcomes when using the GRAF methods in symptomatic transitional segments adjacent to previous successful fusion.

It would therefore seem logical when there is established disc degeneration adjacent to an intended fusion to perform a hybrid procedure in which the secondary degenerative level is controlled by flexible stabilization. This procedure has also been referred to as “Topping Off” and several manufacturers have produced devices to address the issue. There have been no reports as yet to assess the efficacy of such devices.

We have found it relatively simple to combine the implant we are currently using for PLIF surgery (Diapason, Stryker) with the GRAF system. The purpose of this report is to establish whether such usage is clinically effective and, in particular, whether such usage might lead to unpredictable implant failure.


Patients and Methods:

This study reports the outcomes of twenty consecutive patients operated upon by the senior orthopedic surgeon (PD) using hybrid stabilization between January 1996 and June 1998. The minimum follow up is therefore two years (range 2.1 to 4). Patients were scored prospectively using VAS for back and leg pain and Oswestry disability score, and these were repeated at final follow up.

Post-operative lumbar spine radiographs were independently reviewed (MW) to ascertain the integrity of the pedicle screws and to assess the extent of fusion. Spiral computed topography (SCT) with sagittal and coronal reconstruction was performed using a General Electric Hi-Speed Advantage 3.1. In three patients the slice thickness was 3 mm with pitch of 1.5 throughout and in four patients the slice thickness was 3 mm through the pedicle screws and 1 mm with a pitch of 1.5 through the cages.

Successful radiological fusion was assessed using a combination of the plain radiographic and SCT findings using the following criteria:

1. Presence of high attenuation material (trabecular bone) in and between the cages.

2. Presence of high attenuation material (trabecular bone) anterior to the cages (sentinel sign).

3. Absence of bone resorption in adjacent end plates.


Results:

Of the twenty patients reviewed, only fifteen replied to the questionnaire for the assessment sent to them, making the response rate 75%, the female /male ratio is (2:1) chart no 4, There were no complications in this group in terms of neurological damage, infection, wound haematoma, pedicle fracture or implant malposition.

The Oswestry scores were analyzed pre- and post-operatively using t-Test Paired Two Sample for Means show that P value 0.001 which is statistically significance (Table 1).
 


Table 1

The VAS score for the leg pain pre and post op as well as the back pain, using t-Test: Two Sample Assuming Unequal Variances show the P value to be 0.002, and 0.00009 which is very significant statistically (Table 1 and Table 3).
 


Table 2
 


Table 3
 

Of the twenty patients, eleven had radiological investigations available for review. Plain radiographs alone were reviewed in four patients and in these no SCT had been performed. Plain radiographs and SCT were reviewed in six patients and SCT alone in one patient.

Plain radiographs in ten patients showed no evidence of abnormality in the end plates adjacent to the cages and there were no complications relating to the pedicle screws. In two patients, in whom SCT had not been performed, there was a small amount of bone density material lying anteriorly within the intervertebral disc space on respectively the three month and at thirty-three month post-operative radiographs. In another patient the amount of bone density material was extensive on a two months post-operative radiograph and was confirmed by SCT at twelve months after operation.

In the seven patients with SCT for review, there were eight intervertebral disc spaces for evaluation containing sixteen cages. All sixteen of the cages contained high attenuation material consistent with bone and there was no evidence of bone resorption or sclerosis in adjacent end plates. Of the eight intervertebral disc spaces, four (in four patients) showed high attenuation material outside the cages and in three of these the amount of material was small with only one showing an appreciable amount. The high attenuation material lay anterior to both cages and lateral to the right cage in two instances, anteriorly alone in one and between the cages in another.


Discussion:

The assessment of fusion by conventional radiography is problematic not least because it is often technically difficult to visualize the lower lumbar intervertebral disc spaces in profile. Conventional radiography is a relatively insensitive method of detecting bone formation within the intervertebral disc space and SCT is far more sensitive, although it entails a higher radiation dose. However, artifacts from both the titanium cages and pedicle screws hinder SCT interpretation and make absolute measurement of attenuation values unreliable.

In this series the surgical technique used involves the insertion of bone graft material into both the cages and the intervertebral disc space. Thus the bony attenuation material observed on SCT may simply represent consolidated bone graft and it is not certain if true new bone formation has occurred. This uncertainty could only be ascertained by further SCT after a longer interval.

Although the outcomes of this series appear favorable there is no evidence at this stage that they are superior to conventional fusion. There may be a theoretical advantage with decreased stress at the transitional zone.

There is no doubt that two and three level fusion is an arduous procedure and is greatly simplified by reducing the number of levels fused. This series suggests that this can be achieved by using the hybrid technique described. We have not experienced any fusion failure using conventional assessment techniques and there has been no prosthetic failure.


References: 

1. Gardner A; Declerck GM.The GRAF ligamentoplasty procedure, Spine 2000 Jan15; 25(2): 273-6.

2. Brantigan JW; Pseudarthrosis rate after allograft PLIF: Spine 1994 Jun 1; 19(11): 1271-9.

3. Agazzi S; Reverdin A; May D; PLIF with cages: An indepen- dent review of 71 cases, J Neurosurgeon 1999oct; 91(2 suppl): 186-92.

4. Paul C.Mcafee; IBF cages in Reconstructive operations on the spine; JBJS June1999.

ORIGINAL STUDY