New cervical compressive staple: in vitro testing and early clinical results.
METHODS
In vitro testing and retrospective study.


OBJECTIVE
To evaluate the biomechanical and preliminary clinical results of a staple.


BACKGROUND
Anterior cervical discectomy and fusion is currently the most used technique in cervical surgery. Arthrodesis is obtained with a spacer generally secured using a screwed osteosynthesis plate. Implantation of a plate is time consuming and exposes the patient to additional adverse events. The C-JAWS device is a new cervical compressive staple developed to stabilize the spacer.


METHODS
Intact and instrumented behaviors of 6 cervical segments were compared. Instrumentation consisted of a spacer and the staple, fixed at C5-C6 level. The 3-dimensional ranges of motion (ROM) of C5 regarding C6 was tracked. Twenty-three consecutive patients, with single-level cervical disc herniation, were reviewed retrospectively. All patients were treated with anterior cervical discectomy and fusion using a spacer secured by the staple. The Neck Disability Index score and Pain scores were reported; radiographic examinations were used to assess fusion.


RESULTS
Mean ROM were 10 degrees, 8 degrees, and 10 degrees for the intact specimens and 4 degrees, 5 degrees, and 8 degrees for the instrumented ones in flexion-extension, lateral bending, and axial torsion, respectively. The mean clinical follow-up was 24.4 months. The mean operating time was 35 minutes. Patients showed sustained clinical improvement, and radiographic fusion was obtained at last follow-up. No clinical complication was reported except 1 hardware breakage for a borderline indication: the patient reported no complaint, and solid fusion was obtained.


CONCLUSIONS
Experimental results showed reduced ROM of the instrumented spine regarding the intact one. Fusion rate and the occurrence of complication are similar to previous published data. The staple seems to provide a safe and effective new way to stabilize and secure a spacer with a short surgical time. A multicenter prospective clinical study, with more patients, is in progress to confirm these promising results.
*Department of Spinal Surgery, Centre Orthopedique Santy, Lyon †Laboratory of Biomechanics (LBM), ENSAM, Paris, France.
Vincent
V
Fiere
Guillaume
G
Greff
Thomas
T
Mosnier
Alexis
A
Faline
D000293:Adolescent; D000328:Adult; D000368:Aged; D001696:Biomechanical Phenomena; D002102:Cadaver; D002574:Cervical Vertebrae / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D017586:Diskectomy; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011859:Radiography; D016059:Range of Motion, Articular; D013123:Spinal Fusion; D013537:Sutures; D016896:Treatment Outcome; D055815:Young Adult