Gregory C. Dowd, MD * and Fremont P. Wirth, MD, FACS**

* Department of Neurosurgery, Louisiana State University Medical Center, New Orleans, LA

** Savannah Neurological Institute, St. Joseph's Hospital, Savannah, Georgia

[Abstract | Introduction | Methods | Results | Discussion | Conclusions | References]

Abstract:
A prospective, randomized trial was performed comparing anterior cervical discectomy (ACD) with anterior cervical discectomy and fusion (ACDF) for the treatment of cervical spondylosis with neurologic compromise. 44 patients had ACD and 40 underwent ACDF. Operative time, hospital stay and the need for analgesia were less in the ACD group. It was found that while the incidence of fusion was greater in the ACDF group (97% vs 70%, p< 0.01), patient satisfaction and a return to pre operative activity level was similar between groups. This suggests that the addition of a fusion procedure may be unnecessary.


Introduction:
Cervical spondylosis is a process whereby degeneration and instability in the spine are compensated by hypertrophy of the supporting ligamentous structures and bony outgrowths. This process has been described as occurring in three phases: dysfunction, instability and stabilization (22). The end point of this process is auto fusion of the involved joint space. This is an adaptive process in many areas of the body (eg., hip, knee) resulting in increased structural support and some surgical procedures are designed to facilitate this endpoint (arthrodesis). However, the proximity of neurologic structures to the spine can lead to unwanted neurologic side effects of this process(3,12,22). By narrowing the bony spaces within which neural structures lie, compression and dysfunction can occur. Radiculopathy as a result of foraminal stenosis or myelopathy from spinal canal stenosis with spinal cord compression may occur.

Initially, the posterior approach to the cervical spine was utilized (12). Although this yielded favorable results for soft, accessible disc fragments, it provided limited access to and exposure of midline disc fragments and calcified spurs characteristic of cervical spondylosis. Based on the limitations of the posterior approach, the anterior approach to intervertebral disc pathology was developed at several institutions apparently independent of each other. Since this time, controversy has developed concerning the superiority of the anterior or the posterior approach. It has not been demonstrated that one is better than the other. As such, both still have their proponents and detractors (3 4,6,9,19,20).

The initial descriptions of the anterior approach for cervical discectomy all included a fusion procedure (1,3,4). Concern over the possibility of developing late kyphosis from disc space collapse or radiculopathy from foraminal narrowing supported this philosophy. However, as experience with the procedure mounted, it became clear that some patients had relief of the radicular symptoms but developed complications related to the fusion procedure (5). Some surgeons began to perform simple discectomy without the addition of a fusion procedure for these patients (8,10,11,13).

This has led to contention regarding the necessity of a fusion procedure. Many reports are difficult to interpret as the two techniques were utilized at different times and/ or by different surgeons (11,18). In the absence of a randomized prospective study in patients with cervical spondylosis comparing anterior cervical discectomy with and without fusion, firm recommendations regarding the superiority of either approach are difficult to support.To this end, the current study was undertaken.

Methods:
The series reported in this communication represents a three year experience from 1986 until 1989. One hundred consecutive patients presenting with cervical spondylosis of one or two levels and a diagnosis of radiculopathy or radiculo- myelopathy were evaluated for the study. Sixteen patients either withdrew from the study due to patient treatment preferences or did not meet inclusion criteria. The remaining 84 patients were prospectively randomized via closed envelope technique to anterior cervical discectomy alone or with a fusion procedure. This protocol was reviewed and approved by the institutional review board.

All of the patients in this series were managed by the principal investigator (FPW). Additionally, the procedures were performed at a single institution in conjunction with a dedicated neurosurgical operating room staff ensuring a modicum of consistency. The setting was favorable for this study as the patient pool is largely drawn from the local area, which aids in patient follow up.

The surgical technique was quite consistent in all cases with the incision through an appropriate horizontal skin fold on the right side of the neck. Dissection was via the usual route medial to the carotid sheath but lateral to the tracheo- esophageal bundle. Lateral X ray was used to confirm vertebral level. The Cloward retractor system was used deep to the longis colli muscle group. Discectomy was performed utilizing a Smith- Robinson technique but with opening the posterior longtitudinal ligament in all cases and removal of posteriorly directed osteophytes with curette and Kerrison rongeur (Figure 1B). Cases with radiculopathy had foraminal augmentation. The cartilagenous endplates were carefully removed.
A fusion procedure was added for those patients randomized to this arm of the study (Figure 1C). Iliac crest autograft bone via a modified Cloward technique (21) was utilized for fusion. The recipient site and graft were tailored to ensure a snug fit. This was facilitated using cervical traction. No screw or plate fixation was used. Tissues and skin were closed with absorbable sutures. No drains were used. Post operatively, fusion patients wore a soft collar for a period of six weeks.

Clinical follow up was performed while in hospital, during two office visits (five and ten weeks) and at delayed phone contact (mean 4.5 years, range 1.5- 8 years).

Figure 1:Diagramatic representations of the cervical spondylosis in a preoperative state- A; after an anterior cervical discectomy (ACD)-B; after an anterior cervical discectomy and fusion (ACDF)- C.

Results:
Following randomization, 44 patients underwent ACD while 40 patients received ACDF. These groups were found to be comparable on the basis of their demographic data (figure 2),

Figure 2: Demographic data of the 84 patients randomized in this study. The two groups (ACD and ACDF) are comparable. ACD: anterior cervical discectomy; ACDF: anterior cervical discectomy and fusion.

symptoms per patient history (figure 3),

Figure 3: Preoperative symptomatology in the two (ACD v. ACDF) randomized groups. Note that the two groups are quite comparable except for arm weakness- this was a more significant complaint in the ACDF group. However, on neurological examination, there was no significant difference in objective weakness between the two groups.ACD: anterior cervical discectomy; ACDF: anterior cervical discectomy and fusion.

findings on physical exam (figure 4)

Figure 4: Physical examination findings in the two (ACD v. ACDF) randomized groups. Once again, the two groups are comparable.ACD: anterior cervical discectomy; ACDF: anterior cervical discectomy and fusion.

and the form of preoperative therapy that each received (figure 5).

Figure 5: Preoperative therapy and treatment (Rx) duration in two groups (ACD v. ACDF). The two groups are very similar.ACD: anterior cervical discectomy; ACDF: anterior cervical discectomy and fusion.

Importantly, the number of patients with problems caused by motor vehicle accident or involved in compensation claims was similar between groups. More patients in the ACDF group (10/40 vs. 1/44, p< 0.005) complained of arm weakness. However, physical examination (18/40 vs. 18/44, ns) did not support this difference between groups.

The distribution of operative levels and ratio of single/ double level procedures was similar between groups (figure 6).

Figure 6: The distribution of operative levels and the ratio of single/ double procedures is similar in the two groups (ACD v. ACDF).ACD: anterior cervical discectomy; ACDF: anterior cervical discectomy and fusion.

Two level procedures were performed in 59% of the ACD group compared with 50% of the ACDF group.
The presence of myelopathy was determined by evidence of hand intrinsic musculature weakness and/ or pathologic long tract findings. Gait, bowel and bladder function were not recorded. By these criteria,12 patients in the ACD group and 14 patients in the ACDF group demonstrated signs of myelopathy.

The operative time was approximately 29 minutes longer in the ACDF group (131 vs 102 minutes, p< 0.001). This difference and significance were maintained when single and double levels were compared separately. The length of time in post operative unit was not different between groups (103 vs. 98 minutes, ns)

Post operative results were quite different between the two groups. There was no perioperative mortality and no patients deteriorated neurologically. The ACD group was significantly more satisfied with their pain relief (34/44 v 20/40, p<0.01) on the morning following surgery. Patients with ACD requested fewer narcotic shots (3.5 vs. 3.6, ns), narcotic pills (3.6 vs. 4.4, p< 0.05) and non-narcotic analgesics (0.4 vs. 1.0, p< 0.01). Two patients developed transient hoarseness in the ACDF group compared with none in the ACD group. Medical complications (urinary tract infections, atelectasis, elevated leukocyte count, etc.) were significantly fewer in the ACD group (4/44 vs 10/40, p<0.05). Finally, the hospital stay was shorter for the ACD group (3.6 vs. 5.0 days, p< 0.005). Taken together, these data suggest that a fusion procedure adds a significant length of time to the operative procedure. ACDF patients had more pain, developed more medical complications and stayed in the hospital longer.

The two groups were evaluated for rdiographic fusion. Thirty-one patients in each group had complete flexion- extension cervical X ray series post operatively. Patients with two level procedures that showed fusion at only a single level were classified as failures. ACDF patients had a statistically greater fusion rate (30/31 v 22/31, p<0.01). Stratification of patients between one and two level procedures, smoking history or age did not demonstrate any difference in fusion success with multi- variate analyses. However, women were found to have a lower rate of successful fusion (28/37 v 24/25, p<0.05) when compared with men regardless of procedure type.

Post hospital follow up revealed that the discrepancy in pain relief abated by the first office visit ("improved": ACD 40/44 vs. ACDF 37/40, ns). At the second office visit there was near universal improvement in pain (ACD 31/32 vs. ACDF 35/35, ns) in both groups. Phone follow up demonstrated some recrudescence of pain although this was similar between groups. Severe pain was present in some patients ( ACD 4/33 vs ACDF 5/23, ns) at the time of phone follow up.

The number of patients returning to work was greater in the ACD group at both the first (10/44 vs. 4/37, ns) and second (12/32 vs. 10/33, ns) office visits. Phone follow up revealed that more patients in the ACD group had maintained their pre-operative level of activity (24/33 v 15/23, ns). Also, when asked whether the procedure "helped and would be worth repeating given a second chance", patients from both groups were largely satisfied ( ACD 33/33 vs ACDF 22/23, ns). However, these differences do not attain statistical significance.

Two patients required a second operative procedure, both from the ACD group. The first patient had persistence of radicular symptoms following a C5-6 and C6-7 ACD. At four months postoperatively, posterior foraminotomy was performed at these levels with relief of symptoms. The second patient had a C5-6 ACD with immediate relief of symptoms and radiological evidence of successful fusion. She gradually became symptomatic again and underwent C4-5 and C6-7 ACDF eight years after her initial operation.

Discussion:
Cervical spondylosis is a common condition that has been recognized as a major cause of arm and neck pain (13,17). Dysfunction at the level of the intervertebral disc and joint complex is the earliest form of the disorder. This may occur in response to a specific injury or as a result of cumulative wear and tear of an active lifestyle (7,22). Hypertrophy of the supporting tissues in response to this subtle instability occurs. This is a heterogeneous response with ligamentous hypertrophy, joint narrowing, reactive growth from the bony endplates and calcification of the joint capsule. These changes perform the teleologically useful function of stabilizing worn joints with a stable osseous bridge or auto fusion of that joint space (22). Procedures to facilitate arthrodesis have been developed for other joints (eg, knee) to achieve such stability. However, the proximity of neurologic structures to the affected joint complexes may result in adverse consequences (2,7,17,22). This is often the case in the cervical spine. Joint narrowing, ligamentous thickening and bony spurring can cause compression at the root level (ie, radiculopathy) or the spinal cord level (ie, myelopathy). Also, pain related to joint instability may preceed neurologic injury (type III syndrome) (17).

The relative importance of each pathologic change will vary between patients. As such, treatment strategies need to be tailored to match the specific changes present in a given patient. Cervical traction will facilitate foraminal opening and cervical collars aid in minimizing dynamic injury. Strengthening exercises can shift some of the support function away from the spine. However, cases with true mechanical compression of neurologic structures often require surgical intervention (17).

Both anterior and posterior approaches have been used for the treatment of this condition (12,19,20). However, incomplete recovery for pathology situated anterior to the spinal cord has been found following posterior decompression alone (6,19). The treatment of radiculopathy is largely successful with either approach. The anterior approach offers maximal exposure to the pathology centered around the disc space (1,3,14). Following decompression of the involved neurologic structures, many authors favor the use of a fusion procedure (1,3,9,14,17,23). Arguments in favor of this approach include the maintenance of disc space height which avoids vertebral settling and minimizes the potential to develop foraminal stenosis. Also, fusion will remove the instability component of the disorder which may cause progressive deterioration (22).

The necessity of adding a fusion procedure is not universally accepted (5,10,11,13, 15). In the cervical area, fusion has its own set of complications in addition to those of ACD alone (5,16). Most obvious are autogenous donor site complications such as hematoma and neurologic injury to the lateral femoral cutaneous nerve (meralgia paresthetica). Patients often complain of more pain in this area than at the cervical surgical site. The use of allograft material has the potential for transmission of viral particles and other infectious agents. Placing the graft in the recipient site may entail further neck dissection for exposure than discectomy alone. Late complications of cervical fusion include graft extrusion causing spinal cord injury or dysphagia.
The results of this study suggest that a fusion procedure adds little to the ACD alone in the surgical management of cervical spondylosis at one or two levels. The operative time was significantly longer for ACDF patients. The ACDF patients had more pain as measured by initial satisfaction and requests for analgesic medications. The incidence of medical complications, such as atelectasis and urinary tract infection, related to the procedure was greater in the ACDF group and hospital stay was significantly prolonged.

As expected, the rate of successful fusion was statistically different between groups. The ACDF group had a 97% fusion rate compared with 70% in the ACD group. Connolly et al. have found that using cine radiographs, motion was detectable at operative levels which appeared fused on plain films (5). Fusion has been evaluated in a goat model (23). The investigators in this study found only 25% osseous union by histology in levels exhibiting radiological fusion. This suggests that bony fusion is poorly evaluated by radiographic measures and may be inappropriate as an endpoint. A better goal is relief of symptoms and patient satisfaction. This was well achieved with both ACD and ACDF.

Rosenorn reported a series of patients with cervical herniated disc prospectively randomized to anterior cervical discectomy with or without fusion (15). Five separate surgeons participated in this study. Patients undergoing ACD had a significantly greater return to work for the first 9 weeks and superior clinical outcome at both 3 and 12 months. This is especially significant considering that cadaveric donor bone was utilized for fusion procedures in that series.

Conclusions:
The results of the study demonstrate a distinct difference in early patient satisfaction. Operative times were shorter in the ACD group. Post operative pain relief was greater in the ACD group. Post operative requirements for analgesia were less in the ACD group. This resulted in a decreased length of hospitalization in the ACD group. Two patients did require further surgery in the ACD group, but the return to preoperative status and overall satisfaction were equal between groups.

As expected the rate of successful fusion was greater for the ACDF group (97% vs. 70%, p, 0.01). However, this did not correlate with an improved level of satisfaction with the procedure or less long term pain. This would suggest that the addition of a fusion procedure is not absolutely necessary. Procedure selection should be at the discretion of the surgeon and based on individual patient factors.

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