A Comparison of Clinical Outcomes between Early Cervical Spine Stabilizer Training and Usual Care in Individuals following Anterior Cervical Discectomy and Fusion.

OBJECTIVES: Early physical therapy (PT) with specific stabilization training has been shown to benefit individuals after lumbar spinal surgery but has not been studied in patients after cervical spine surgery. The primary purpose of this study was to compare clinical outcomes between early cervical spine stabilizer (ECS) training and usual care (UC) in patients after anterior cervical discectomy and fusion (ACDF) surgery. The secondary purpose was to determine test-retest reliability of strength and endurance tests of cervical spinal stabilizers in this patient population. METHODS: Forty participants who were scheduled for ACDF surgery were randomized into either the ECS group or the UC group. After surgery, participants received their assigned group intervention during their hospital stay and continued their assigned intervention for 12 weeks. All participants had phone follow-ups twice during the first 6 weeks to address questions or problems. Clinical outcome measures including pain level using the Numeric Pain Rating Scale (NPRS), disability level using the Neck Disability Index (NDI), Craniocervical Flexor Strength (CCF-S), and Craniocervical Flexor Endurance (CCF-E) were collected three times: before surgery and 6 and 12 weeks after surgery. Test-retest reliability was assessed in the first 10 participants. RESULTS: There was no significant interaction between the groups over time for any of the outcome measures. However, all participants made significant improvements in all four outcome measures at 6 and 12 weeks post surgery. The results showed good-to-excellent test-retest reliability for the CCF-S and CCF-E tests. CONCLUSIONS: Both ECS training and UC resulted in the same amount of improvement at 6 and 12 weeks; therefore, both therapy approaches appear to have similar and positive effects on patients in their first 3 months of recovery after ACDF. Both the CCF-S and CCF-E tests can be used reliably to assess the strength and endurance of the cervical spinal stabilizers for patients after ACDF surgery. The study was registered with the ClinicalTrials.gov (NIH, U.S. National Library of Medicine, identifier # NCT01519115) Protocol Registration system.

Symptomatic adjacent segment disease after cervical total disc replacement: re-examining the clinical and radiological evidence with established criteria.

BACKGROUND CONTEXT: Although several publications in the last decade have proved equality in safety and efficacy of the total disc replacement (TDR) to the anterior fusion procedure in cervical spine, the claim that TDR may reduce the incidence of adjacent segment disease (ASD) has not been corroborated by clinical evidence. PURPOSE: We attempt to predict the true incidence of symptomatic ASD after TDR surgery in the cervical spine at one or two levels at a median follow-up period of 4 years. STUDY DESIGN: A total of 763 patients were screened to participate in four different Food and Drug Administration device exemption trials for artificial cervical disc replacement at three collaborating institutions. Two hundred seventy-one patients qualified and enrolled in the trials. One hundred seventy-three randomized to receive artificial disc replacement surgery, and 167 have completed a 4-year or longer follow-up. OUTCOME MEASURES: Patients experiencing cervical radiculopathy symptoms in the follow-up period were worked-up with clinical examinations, magnetic resonance imaging of the cervical spine, and other diagnostic studies. Once a clinical correlation was established with the imaging evidence of adjacent segment degeneration, a careful record was maintained to document the subsequent medical and/or surgical treatment received by these patients. Statistical analysis was performed to determine the true incidence of and factors affecting the ASD after cervical disc replacement in these patients. RESULTS: Twenty-six patients (15.2%) were identified to satisfy our criteria for ASD at the median follow-up of 51 months, with the annual incidence of 3.1% as calculated by life tables. The actuarial 5-year freedom from ASD rate was 71.6%±0.6%, and the mean period for freedom from ASD was 70.4±2.1 months. CONCLUSIONS: The incidence of symptomatic ASD after cervical TDR is 3.1% annually regardless of the patient's age, sex, smoking habits, and design of the TDR device. The presence of osteopenia and lumbar degenerative disease significantly increase the risk of developing ASD after anterior cervical surgery.

Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article.

OBJECT: Cervical total disc replacement (CTDR) represents a relatively novel procedure intended to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. This prospective, randomized, multicenter study evaluates the safety and efficacy of a new metal-on-metal CTDR implant (Kineflex|C) by comparing it with ACDF in the treatment of single-level spondylosis with radiculopathy. METHODS: The study was a prospective, randomized US FDA Investigational Device Exemption (IDE) pivotal trial conducted at 21 centers across the US. The primary clinical outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS) scores, and a composite measure of clinical success. Patients were randomized to CTDR using the Kineflex|C (SpinalMotion, Inc.) cervical artificial disc or ACDF using structural allograft and an anterior plate. RESULTS: A total of 269 patients were enrolled and randomly assigned to either CTDR (136 patients) or to ACDF (133 patients). There were no significant differences between the CTDR and ACDF groups when comparing operative time, blood loss, length of hospital stay, or the reoperation rate at the index level. The overall success rate was significantly greater in the CTDR group (85%) compared with the ACDF group (71%) (p = 0.05). In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 24-month follow-up (p < 0.0001). Similarly, the VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 24-month follow-up (p < 0.0001). The range of motion (ROM) in the CTDR group decreased at 3 months but was significantly greater than the preoperative mean at 12- and 24-month follow-up. The ROM in the ACDF group was significantly reduced by 3 months and remained so throughout the follow-up. Adjacent-level degeneration was also evaluated in both groups from preoperatively to 2-year follow-up and was classified as none, mild, moderate, or severe. Preoperatively, there were no significant differences between groups when evaluating the different levels of adjacent-level degeneration. At the 2-year follow-up, there were significantly more patients in the ACDF group with severe adjacent-level radiographic changes (p < 0.0001). However, there were no significant differences between groups in adjacent-level reoperation rate (7.6% for the Kineflex|C group and 6.1% for the ACDF group). CONCLUSIONS: Cervical total disc replacement allows for neural decompression and clinical results comparable to ACDF. Kineflex|C was associated with a significantly greater overall success rate than fusion while maintaining motion at the index level. Furthermore, there were significantly fewer Kineflex|C patients showing severe adjacent-level radiographic changes at the 2-year follow-up. These results from a prospective, randomized study support that Kineflex|C CTDR is a viable alternative to ACDF in select patients with cervical radiculopathy.