Artificial disc replacement and adjacent-segment pathology: 10-year outcomes of a randomized trial

J Neurosurg Spine 36:945–953, 2022

Artificial disc replacement (ADR) is designed to preserve motion and thus protect against adjacent segment pathology (ASP) and act as an alternative treatment to fusion surgery. The question remains, how well do ADR devices perform after 10 years of follow-up compared with fusion surgery in terms of patient satisfaction, sustainability, and protection against ASP?

METHODS This was the 10-year follow-up study of 153 participants who underwent ADR or fusion surgery after anterior decompression due to cervical degenerative radiculopathy (ISRCTN registration no. 44347115). Scores on the Neck Disability Index (NDI), EQ-5D, and visual analog scale for neck and arm pain were obtained from the Swedish Spine Registry and analyzed using ANCOVA. Information about secondary surgical procedures was collected from medical records and presented as Kaplan-Meier curves. MRI and flexion-extension radiography were performed, and ASP was
graded according to the Miyazaki classification system.

RESULTS Ten participants were lost to follow-up, which left 143 participants (80 underwent ADR and 65 underwent anterior cervical discectomy and fusion). There were no differences between groups in terms of patient-reported outcome measures (10-year difference in NDI scores 1.7 points, 95% CI −5.1 to 8.5, p = 0.61). Nineteen (24%) participants in the ADR group compared with 9 (14%) in the fusion group underwent secondary surgical procedures. The higher reoperation rate of the ADR group was mainly due to 11 female participants with device loosening. The rates of reoperation due
to ASP were similar between groups, which was confirmed with MRI assessment of ASP that also showed no differences between the groups (p = 0.21).
CONCLUSIONS This was the first 10-year follow-up study to compare ADR with fusion surgery and to provide MRI information for the assessment of ASP. The authors found no benefit of ADR over fusion surgery after anterior  decompression for cervical degenerative radiculopathy.

 

Posterior foraminotomy versus anterior decompression and fusion in patients with cervical degenerative disc disease with radiculopathy

J Neurosurg Spine 32:344–352, 2020

The long-term efficacy of posterior foraminotomy compared with anterior cervical decompression and fusion (ACDF) for the treatment of degenerative disc disease with radiculopathy has not been previously investigated in a population-based cohort.

METHODS All patients in the national Swedish Spine Register (Swespine) from January 1, 2006, until November 15, 2017, with cervical degenerative disc disease and radiculopathy were assessed. Using propensity score matching, patients treated with posterior foraminotomy were compared with those undergoing ACDF. The primary outcome measure was the Neck Disability Index (NDI), a patient-reported outcome score ranging from 0% to 100%, with higher scores indicating greater disability. A minimal clinically important difference was defined as > 15%. Secondary outcomes were assessed with additional patient-reported outcome measures (PROMs).

RESULTS A total of 4368 patients (2136/2232 women/men) met the inclusion criteria. Posterior foraminotomy was performed in 647 patients, and 3721 patients underwent ACDF. After meticulous propensity score matching, 570 patients with a mean age of 54 years remained in each group. Both groups had substantial decreases in their NDI scores; however, after 5 years, the difference was not significant (2.3%, 95% CI −4.1% to 8.4%; p = 0.48) between the groups. There were no significant differences between the groups in EQ-5D or visual analog scale (VAS) for neck and arm scores. The secondary surgeries on the index level due to restenosis were more frequent in the foraminotomy group (6/100 patients vs 1/100), but on the adjacent segments there was no difference between groups (2/100).

CONCLUSIONS In patients with cervical degenerative disc disease and radiculopathy, both groups demonstrated clinical improvements at the 5-year follow-up that were comparable and did not achieve a clinically important difference from one another, even though the reoperation rate favored the ACDF group. This study design obtains population-based results, which are generalizable.

Effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blinded randomised controlled trial

The Spine J Volume 19, Issue 6, Pages 965–975. 2019

Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent disc degeneration as compared to anterior cervical discectomy and fusion (ACDF). Prior reports suggest that ACDF is not more effective than anterior cervical discectomy (ACD) alone for the treatment of cervical radiculopathy.

Purpose: To evaluate whether patients with cervical radiculopathy due to a herniated disc benefit more from undergoing ACDA, ACDF, or ACD in terms of clinical outcome measured by the Neck Disability Index (NDI).

Study design: Double-blinded randomized controlled trial

Methods: One hundred-nine patients with one level herniated disc were randomized to one of the following treatments: ACDA, ACDF with intervertebral cage, ACD without fusion. Clinical and radiological outcome was measured by NDI, Visual Analogue Scale (VAS) neck pain, VAS arm pain, SF36, EQ-5D, patients’ self-reported perceived recovery, radiographic cervical curvature, and adjacent segment degeneration (ASD) parameters at baseline and until two years after surgery. BBraun Medical paid €298.837 to cover the costs for research nurses.

Results: The NDI declined from 41 to 47 points at baseline to 19±15 in the ACD group, 19± 18 in the ACDF group, and 20±22 in the ACDA group after surgery (p=0.929). VAS arm and neck pain declined to half its baseline value and decreased below the critical value of 40 mm. Quality of life, measured by the EQ-5D, increased in all three groups. ASD parameters were comparable in all three groups as well. No statistical differences were demonstrated between the treatment groups.

Conclusions: The hypothesis that ACDA would lead to superior clinical outcome in comparison to ACDF or ACD could not be confirmed during a two-year follow-up time period. Single level ACD without implanting an intervertebral device may be a reasonable alternative to ACDF or ACDA.

Artificial disc replacement versus fusion in patients with cervical degenerative disc disease and radiculopathy: a randomized controlled trial with 5-year outcomes

J Neurosurg Spine 30:323–331, 2019

The method of artificial disc replacement (ADR) has been developed as an alternative treatment to fusion surgery after decompression for cervical degenerative disc disease (DDD) with radiculopathy. Preserving the motion of ADR devices aims to prevent immobilization side effects such as adjacent-segment pathology (ASP). However, longterm follow-up evaluations using MRI are needed to investigate if this intent is achieved.

METHODS The authors performed a randomized controlled trial with 153 patients (mean age 47 years) undergoing surgery for cervical radiculopathy. Eighty-three patients received an ADR and 70 patients underwent fusion surgery. Outcomes after 5 years were assessed using patient-reported outcome measures using the Neck Disability Index (NDI) score as the primary outcome; motion preservation and heterotopic ossification by radiography; ASP by MRI; and secondary surgical procedures.

RESULTS Scores on the NDI were approximately halved in both groups: the mean score after 5 years was 36 (95% confidence interval [CI] 31–41) in the ADR group and 32 (95% CI 27–38) in the fusion group (p = 0.48). There were no other significant differences between the groups in six other patient-related outcome measures. Fifty-four percent of the patients in the ADR group preserved motion at the operated cervical level and 25% of the ADRs were spontaneously fused. Seventeen ADR patients (21%) and 7 fusion patients (10%) underwent secondary surgery (p = 0.11), with 5 patients in each group due to clinical ASP.

CONCLUSIONS In patients with cervical DDD and radiculopathy decompression as well as ADR, surgery did not result in better clinical or radiological outcomes after 5 years compared with decompression and fusion surgery.

Clinical trial registration no.: 44347115 (ISRCTN).

Artificial disc replacement versus fusion in patients with cervical degenerative disc disease with radiculopathy: 5-year outcomes from the National Swedish Spine Register

J Neurosurg Spine 30:159–167, 2019

The long-term efficacy of artificial disc replacement (ADR) surgery compared with fusion after decompression for the treatment of cervical degenerative disc disease and radiculopathy has not previously been investigated in a population-based setting.

METHODS All patients with cervical degenerative disc disease and radiculopathy who were in the national Swedish Spine Registry (Swespine) beginning in January 1, 2006, were eligible for the study. Follow-up information was obtained up to November 15, 2017. The authors compared, using propensity score matching, patients treated with anterior decompression and insertion of an ADR with patients who underwent anterior decompression combined with fusion surgery.
The primary outcome was the Neck Disability Index (NDI), a patient-reported function score ranging from 0% to 100%, with higher scores indicating greater disability and a minimum clinically important difference of > 15%.

RESULTS A total of 3998 patients (2018:1980 women/men) met the inclusion criteria, of whom 204 had undergone arthroplasty and 3794 had undergone fusion. After propensity score matching, 185 patients with a mean age of 49.7 years remained in each group. Scores on the NDI were approximately halved in both groups after 5 years, but without a significant mean difference in NDI (3.0%; 95% CI -8.4 to 2.4; p = 0.28) between the groups. There were no differences between the groups in EuroQol–5 Dimensions or in pain scores for the neck and arm.

CONCLUSIONS In patients with cervical degenerative disc disease and radiculopathy, decompression plus ADR surgery did not result in a clinically important difference in outcomes after 5 years, compared with decompression and fusion surgery.

A 5- to 8-year randomized study on the treatment of cervical radiculopathy: anterior cervical decompression and fusion plus physiotherapy versus physiotherapy alone

Journal of Neurosurgery: Spine 26(1):19-27

The aim of this study was to evaluate the 5- to 8-year outcome of anterior cervical decompression and fusion (ACDF) combined with a structured physiotherapy program as compared with that following the same physiotherapy program alone in patients with cervical radiculopathy. No previous prospective randomized studies with a follow-up of more than 2 years have compared outcomes of surgical versus nonsurgical intervention for cervical radiculopathy.

METHODS: Fifty-nine patients were randomized to ACDF surgery with postoperative physiotherapy (30 patients) or to structured physiotherapy alone (29 patients). The physiotherapy program included general and specific exercises as well as pain coping strategies. Outcome measures included neck disability (Neck Disability Index [NDI]), neck and arm pain intensity (visual analog scale [VAS]), health state (EQ-5D questionnaire), and a patient global assessment. Patients were followed up for 5–8 years.

RESULTS: After 5–8 years, the NDI was reduced by a mean score% of 21 (95% CI 14–28) in the surgical group and 11% (95% CI 4%–18%) in the nonsurgical group (p = 0.03). Neck pain was reduced by a mean score of 39 mm (95% CI 26–53 mm) compared with 19 mm (95% CI 7–30 mm; p = 0.01), and arm pain was reduced by a mean score of 33 mm (95% CI 18–49 mm) compared with 19 mm (95% CI 7–32 mm; p = 0.1), respectively. The EQ-5D had a mean respective increase of 0.29 (95% CI 0.13–0.45) compared with 0.14 (95% CI 0.01–0.27; p = 0.12). Ninety-three percent of patients in the surgical group rated their symptoms as “better” or “much better” compared with 62% in the nonsurgical group (p = 0.005). Both treatment groups experienced significant improvement over baseline for all outcome measures.

CONCLUSIONS: In this prospective randomized study of 5- to 8-year outcomes of surgical versus nonsurgical treatment in patients with cervical radiculopathy, ACDF combined with physiotherapy reduced neck disability and neck pain more effectively than physiotherapy alone. Self-rating by patients as regards treatment outcome was also superior in the surgery group. No significant differences were seen between the 2 patient groups as regards arm pain and health outcome.

 

Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion

Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion

J Neurosurg Spine 23:558–573, 2015

This study compared the safety and efficacy of treatment with the PRESTIGE LP cervical disc versus a historical control anterior cervical discectomy and fusion (ACDF).

METHODS Prospectively collected PRESTIGE LP data from 20 investigational sites were compared with data from 265 historical control ACDF patients in the initial PRESTIGE Cervical Disc IDE study. The 280 investigational patients with single-level cervical disc disease with radiculopathy and/or myelopathy underwent arthroplasty with a low-profile artificial disc. Key safety/efficacy outcomes included Neck Disability Index (NDI), Neck and Arm Pain Numerical Rating Scale scores, 36-Item Short Form Health Survey (SF-36) score, work status, disc height, range of motion, adverse events (AEs), additional surgeries, and neurological status. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Predefined Bayesian statistical methods with noninformative priors were used, along with the propensity score technique for controlling confounding factors. Analysis by independent statisticians confirmed initial statistical findings.

RESULTS The investigational and control groups were mostly similar demographically. There was no significant difference in blood loss (51.0 ml [investigational] vs 57.1 ml [control]) or hospital stay (0.98 days [investigational] vs 0.95 days [control]). The investigational group had a significantly longer operative time (1.49 hours vs 1.38 hours); 95% Bayesian credible interval of the difference was 0.01–0.21 hours. Significant improvements versus preoperative in NDI, neck/arm pain, SF-36, and neurological status were achieved by 1.5 months in both groups and were sustained at 24 months. Patient follow-up at 24 months was 97.1% for the investigational group and 84.0% for the control group. The mean NDI score improvements versus preoperative exceeded 30 points in both groups at 12 and 24 months. SF-36 Mental Component Summary superiority was established (Bayesian probability 0.993). The mean SF-36 PCS scores improved by 14.3 points in the investigational group and by 11.9 points in the control group from baseline to 24 months postoperatively. Neurological success at 24 months was 93.5% in the investigational group and 83.5% in the control group (probability of superiority ~ 1.00). At 24 months, 12.1% of investigational and 15.5% of control patients had an AE classified as device or device/surgical procedure related; 14 (5.0%) investigational and 21 (7.9%) control patients had a second surgery at the index level. The median return-to-work time for the investigational group was 40 days compared with 60 days for the control group (p = 0.020 after adjusting for preoperative work status and propensity score). Following implantation of the PRESTIGE LP device, the mean angular motion was maintained at 12 months (7.9°) and 24 months (7.5°). At 24 months, 90.0% of investigational and 87.7% of control patients were satisfied with the results of surgery. PRESTIGE LP superiority on overall success (without disc height success), a composite safety/efficacy end point, was strongly supported with 0.994 Bayesian probability.

CONCLUSIONS This device maintains mean postoperative segmental motion while providing the potential for biomechanical stability. Investigational patients reported significantly improved clinical outcomes compared with baseline, at least noninferior to ACDF, up to 24 months after surgery.

Anterior Cervical Reconstruction With Pedicle Screws After a 4-Level Corpectomy

Spine 2012 ; 37 : E927 – E930

Anterior reconstruction after multilevel corpectomy is a challenging technique, and there are many reports on its complications. Graft dislodgement is one of the major complications after long cervical fusion. The main cause of failure seems to be a lack of stability in the conventional reconstruction technique. However, pedicle screws for posterior cervical reconstruction show remarkable stability. We describe a new technique of anterior cervical reconstruction with pedicle screws and fibular strut grafting.

Methods. Seven patients with multilevel cervical myelopathy were treated with this new reconstruction technique after a 4-level corpectomy. We describe this new technique and review the patients’ clinical history, results of radiographical imaging, and outcomes. Clinical outcomes were assessed preoperatively and at 3 months postoperatively. Postoperative radiographs were assessed 3 months and 6 months postoperatively.

Results. The mean operative time was 182 minutes and the mean blood loss was 271 mL. The average Japanese Orthopaedic Association score for cervical myelopathy improved from 11.5 points preoperatively to 14.5 points 3 months postoperatively. No patients experienced major complications, such as neurological deterioration, infection, or massive blood loss. There was no case of reconstruction failure, graft dislodgement, migration, or screw displacement.

Conclusion. To our knowledge, this is the first description of an anterior cervical reconstruction approach, using pedicle screws and fibular strut grafting after a 4-level corpectomy. It is likely that this technique will result in better clinical outcomes with fewer complications in the treatment of patients with multilevel cervical myelopathy.