Design
This is a prospective, randomized, contrastive clinical study.
Time and setting
This study was conducted at the Shanghai First People’s Hospital Affiliated to Shanghai Jiao Tong University in China between December 2006 and December 2009.
Subjects
A total of 80 patients with a consecutive sequence of hospitalization were randomized in a 1:1 ratio to a anterior cervical discectomy and fusion group (ACDF group) and a anterior cervical corpectomy and fusion group (ACCF group) using the envelope method[7].
The inclusion criteria were (1) cervical myelopathy with no response to 6 weeks of conservative treatment and (2) cervical spine radiography, CT, and/or MRI showing two-level contiguous intervertebral disc herniation and/or posterior border osteophyte of vertebral body.
The exclusion criteria were single-level or more than two-level CSM, two-level CSM without continuity, and CSM with congenital deformity, previous cervical injury and/or cervical surgery, and ossification of the posterior longitudinal ligament.
All patients provided informed consent before surgery. The study was approved by the Ethics Committee of Shanghai First People’s Hospital.
Materials
A total of 66 cages, including Bengal (19 patients), Depuy Synthes Spine, Raynham, MA, USA; Stryker Solis (7 patients), Stryker Australia Pty. Ltd., St. Leonards, NSW, Australia; AO Syncage (7 patients), Synthes Spine, West Chester, PA, USA, were used in ACDF group.
A total of 36 plate-meshes, including Codman® (4 patients), Codman & Shurtleff, Inc., Raynham, MA, USA; Slim-Loc™ (3 patients), DepuySynthes Spine; Skyline® (9 patients), DepuySynthes Spine; Orion™ (4 patients), Medtronic, Inc., Minneapolis, MN, USA; Zephir™ (9 patients), Medtronic, Inc.; CSLP-VA (3 patients), Synthes GmbH, Oberdorf, Switzerland; Reflex® Hybrid (4 patients), Stryker Spine, Mahwah, NJ, USA, were used in ACCF group.
Methods
Operation
The preoperative American Society of Anesthesiologists (ASA) classification scores of all patients were less than 3. Patients received general anesthetic via tracheal intubation. The patient was supine on operating table and neck was supported with sandbag in neutral position. Anterior approach through the transverse incision along the skin crease was made to expose the anterior surface of vertebrae through the space between the carotid sheath and the trachea and esophagus. Disc level was identified using a needle mark inserted into the disc space and was confirmed by intraoperative fluoroscopy.
For patients in the ACDF group, after an interbody pin distractor system was used above and below the discectomy site, a transverse incision through the anterior longitudinal ligament was made at the middle of the disc space. The disc tissue and endplate cartilage were cut and removed using curette. After flushing the space with cold saline, an expanding decompression was made using the different angle smaller diameter curettes to remove the osteophytes on the posterior lips of the vertebrae, then used 1-mm laminectomy punch to cut the posterior longitudinal ligament at the disc space. The dura matter was inspected and no compression of dura matter was assured. After re-flushing the decompressed space with cold saline, small-size gelfoam was inserted into the deep part of the disc space. After appropriate-size cages were selected to fit the interbody space defect. The cages were packed with local decompression bone harvested from the decompression of the posterior border of vertebral body and were then inserted into corresponding interbody space defect under further 1-mm more traction. Proper hardware placement was confirmed by intraoperative fluoroscopy.
For patients in the ACCF group, an interbody pin distractor system was used above and below the corpectomy site. After incised the anterior longitudinal ligament and disc tissue and endplate cartilage at affected disc space, the corresponding interspace vertebral body was excised using a rongeur and different angle smaller diameter curettes. The corresponding posterior longitudinal ligament was incised used 1.0-2.0 mm laminectomy punch. The dura matter was inspected and no compression of dura matter was assured. After flushing the space with cold saline, proper size gelfoam was carefully placed on the dura matter. An appropriate titanium mesh was selected and cut down to fit the corpectomy defect. The mesh was packed with local vertebra bone harvested from decompression and was then inserted into the corpectomy defect under further 1 mm traction. Finally, an anterior cervical titanium plate and screws were applied to achieve anterior cervical fixation. Proper hardware placement was confirmed by intraoperative fluoroscopy.
After operation for both groups, the patients were placed in a soft collar for 6 weeks and encouraged to resume their normal activities.
Clinical evaluation
All data were collected and reviewed by an independent spine surgeon (LZ) using a standardized data-collection form. The neurological function improvement was assessed by the Japanese Orthopaedic Association (JOA) score, which was recorded before surgery and at 5-year follow-up. A full JOA score was defined as 17 points, 8 for upper and lower motor function, 6 for sensory functions, and 3 for bladder rectal function
[3]. Neck and radicular pain was evaluated using the Visual Analogue Scale (VAS) before surgery and at 5-year follow-up. Clinical outcome was assessed according to the Odom criteria as shown in Table 1.
Radiological evaluation
The cervical lordoses were indicated by the methods of Cobb angle of C2-7 and operated segments. The C2-7 Cobb angle was the angle between the inferior endplate line of C2 and inferior endplate line of C7 in a neutral position. The segmental Cobb angle was the angle between the superior endplate line of the cephalad vertebral body and the inferior endplate line of caudal vertebral body of the operated segments in a neutral position. Lordosis is shown as a positive value and kyphosis is shown as a negative value (Figure 1). The Segmental height was measured using the method of Oh et al. [6] and defined as the distance between the midlines of involvedcranial vertebral bodies and caudal vertebral bodies (Figure 1). Instrument subsidence was recorded when the loss of segmental height correction was over 3 mm. Fusion was considered according to the following accepted criteria: (1) absence of motion between the spinous processes at dynamic lateral radiographs, (2) presence of continuous bridging bony trabeculae at the graft-endplate interface[8].
Main outcome measures
There were (1) perioperative parameters, including patients’ age, sex, smoking condition, body mass index, ASA classification scores, and surgery levels; (2) clinical evaluations included JOA score and VAS score before and at 5-year follow-up after surgery. The Odom score, fusion rate, and complications at 5-year follow-up after surgery. (3) Radiological
evaluations included the segmental and C
2-7 Cobb angles, segmental heights, the instrument subsidence rates, and the instrument dislocations before and at 5-year follow-up after surgery.
Statistical analysis
Between-group comparisons of the continuous variables were performed using the two-sample
F-test for variances, followed by unpaired
t-tests. Between-group comparisons of the categorical variables were performed using the chi-square test or Fisher’s exact test. The analysis of Cobb’s angles and segmental heights between groups at each corresponding time point used
t-test (two-sample assuming equal variances or unequal variances according its
F-test two-sample for variances). The analysis of Cobb’s angles and segmental heights within group at each corresponding time point used
t-test (paired two-sample for means).The statistical tests were completed by the SPSS 17.0 software (SPSS Inc, Chicago, IL, USA). In all tests, the difference was considered to be statistically significant at the
P values less than 0.05 level.
中国组织工程研究杂志出版内容重点:人工关节;骨植入物;脊柱;骨折;内固定;数字化骨科;组织工程