Ludek Vavruch

A prospective randomized comparison between the cloward procedure and a carbon fiber cage in the cervical spine: a clinical and radiologic study.

Study Design. A prospective randomized study was conducted. Objective. To determine whether the use of a cervical carbon fiber intervertebral fusion cage improves the outcome of anterior cervical decompression and fusion, as compared with the Cloward procedure using autograft. Summary of Background Data. Despite the theoretical advantages of using intervertebral cages, including reduced donor site morbidity and prevention of graft collapse, an improved clinical outcome has not yet been documented. Methods. For this study, 103 patients were randomized to anterior cervical decompression and fusion with a carbon fiber intervertebral fusion cage (n = 52) or the Cloward procedure (n = 51). An independent observer quantified pain and functional disability. Fusion rate, segmental kyphosis, and disc height were assessed by radiographs. Results. During a mean follow-up period of 36 months (range, 24–72 months) for 89 patients (86%), the pain and disability were similar for both treatments. Postoperative donor site pain was significantly less in the carbon fiber intervertebral fusion cage group. The fusion rate was 86% in the Cloward procedure group and 62% in the carbon fiber intervertebral fusion cage group (P < 0.05). In the latter group, patients with pseudarthrosis reported more severe pain than fused patients (51 and 33 visual analog scores, respectively), but the difference was not significant. The segmental kyphosis was less and the disc height increased in the carbon fiber intervertebral fusion cage group, as compared with the Cloward procedure group. Disc height was not correlated with outcome. Segmental kyphosis showed a weak (r = −0.3) but significant (P < 0.05) correlation with improvement of the Cervical Spine Functional Score, but not with other outcome variables. Conclusions. Except for reduced donor site pain, the clinical outcome for the carbon fiber intervertebral fusion cage is the same as for the Cloward procedure. Use of the cage results in a more lordotic alignment and an increased disc height, but in a higher pseudarthrosis rate than use of the Cloward procedure.

Predictive factors for the outcome of anterior cervical decompression and fusion.

In a prospective study, 103 patients were randomised to anterior cervical decompression and fusion (ACDF) with a cervical carbon-fibre intervertebral fusion cage or the Cloward procedure. Preoperative background variables, active range of neck motion, handgrip strength, radiological evaluation and subjective variables were used in a multiple regression model to find the strongest predictors of postoperative outcome as measured by current pain intensity and the Neck Disability Index (NDI). Male sex, greater kyphosis at the level operated on, non-smoking, a greater neck mobility in right rotation, low disability on NDI, and older age were predictors of pain reduction and explained 30% of current pain intensity at follow-up. Higher educational level, non-smoking, greater kyphosis at the level operated on, a greater flexion mobility, greater right handgrip strength and lower current pain intensity were predictors of improvement, and explained 28% of the postoperative outcome on NDI. The most important predictor for postoperative pain intensity was the magnitude of the preoperative kyphosis. Preoperative pain intensity was the most important predictor for improved NDI. At follow-up about 70% of the patients still had deficit based on current pain intensity and NDI, and 44% had remaining dysfunction based on Odoms criteria. In conclusion, the multivariate analysis shows that male sex, non-smoking, greater segmental kyphosis and a low pain and disability level are preoperative predictors of a good outcome in ACDF. In addition, the study suggests the importance of other predictive variables than those studied for the outcome of ACDF.

Clinical and radiological evaluation of Trabecular Metal and the Smith–Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up

A prospective, randomized, controlled study was carried out to compare the radiological and clinical outcomes after anterior cervical decompression and fusion (ACDF) with Trabecular Metal™ (TM) to the traditional Smith–Robinson (SR) procedure with autograft. The clinical results of cervical fusion with autograft from the iliac crest are typically satisfactory, but implications from the donor site are frequently reported. Alternative materials for cervical body interfusion have shown lower fusion rates. Trabecular Metal is a porous tantalum biomaterial with structure and mechanical properties similar to that of trabecular bone and with proven osteoconductivity. As much as 80 consecutive patients planned for ACDF were randomized for fusion with either TM or tricortical autograft from the iliac crest (SR) after discectomy and decompression. Digitized plain radiographic images of 78 (98%) patients were obtained preoperatively and at 2-year follow-up and were subsequently evaluated by two senior radiologists. Fusion/non-fusion was classified by visual evaluation of the A–P and lateral views in forced flexion/extension of the cervical spine and by measuring the mobility between the fused vertebrae. MRI of 20 TM cases at 2xa0years was successfully used to assess the decompression of the neural structures, but was not helpful in determining fusion/non-fusion. Pain intensity in the neck, arms and pelvis/hip were rated by patients on a visual analog scale (VAS) and neck function was rated using the Neck Disability Index (NDI) the day before surgery and 4, 12 and 24xa0months postoperatively. Follow-ups at 12 and 24xa0months were performed by an unbiased observer, when patients also assessed their global outcome. Fusion rate in the SR group was 92%, and in the TM group 69% (Pxa0<xa00.05). The accuracy of the measurements was calculated to be 2.4°. Operating time was shorter for fusion with TM compared with autograft; mean times were 100xa0min (SD 18) and 123xa0min (SD 23), respectively (Pxa0=xa00.001). The patients’ global assessments of their neck and arm symptoms 2xa0years postoperatively for the TM group were rated as 79% much better or better after fusion with TM and 75% using autograft. Pain scores and NDI scores were significantly improved in both groups when compared with baseline at all follow-ups, except for neck pain at 1xa0year for the TM group. There was no statistically significant difference in clinical outcomes between fusion techniques or between patients who appeared radiologically fused or non-fused. There was no difference in pelvic/hip pain between patients operated on with or without autograft. In our study, Trabecular Metal showed a lower fusion rate than the Smith–Robinson technique with autograft after single-level anterior cervical fusion without plating. There was no difference in clinical outcomes between the groups. The operative time was shorter with Trabecular Metal implants.

Predictive factors for arm pain, neck pain, neck specific disability and health after anterior cervical decompression and fusion

SummaryBackground. Predictive factors for a low arm and neck pain, and good health after anterior cervical decompression and fusion (ACDF) with a cervical carbon fibre intervertebral fusion cage (CIFC) are still lacking.n Method. A prospective consecutive study to investigate which preoperative factors that could predict a good outcome with regard to arm pain, neck pain, Neck Disability Index (NDI) and general health three years after ACDF with CIFC was conducted. Thirty-four patients were included before surgery. Measurements took place the day before, six months, one year and three years after ACDF.n Findings. In multivariate analysis, to be a non-smoker before surgery was the most important factor for a low postoperative arm pain, a low pain frequency was the most important factor for low postoperative neck pain, normal rating on Distress and Risk Assessment Method (DRAM) was the most important factor for high function on NDI and a low initial pain intensity was the most important factor for good postoperative health. For all outcome variables a normal rating on DRAM was an important factor for a good outcome.n Conclusions. Non-smoking, a low pain level and normal rating on DRAM were the best preoperative predictors of a good outcome in ACDF. Inclusion criteria for surgery should be based on a bio psychosocial model and DRAM seems to be useful for including the traditional inclusion criteria.

Long-term randomised comparison between a carbon fibre cage and the Cloward procedure in the cervical spine

A prospective randomised study. To compare the long-term outcome of anterior cervical decompression and fusion (ACDF) with a cervical intervertebral fusion cage (CIFC) and the Cloward procedure (CP). We have previously shown that the 2xa0year outcome of ACDF with the CIFC is the same as for the CP. The fusion rate in CIFC group was, however, only 55%, compared to 85% in CP group. The long-term outcome of CIFC is poorly documented. Ninety-five patients with at least 6xa0months duration of neck pain and radicular arm pain were randomly allocated for ACDF with the CIFC or the CP. Radiographs were obtained at 2xa0years. Questionnaires about pain, disability (Neck Disability Index, NDI), distress, quality of life and global outcome were obtained from 83 patients (87%) (43 CIFC, 40 CP) at a mean follow-up time of 6xa0years (range 56–94xa0months). There were no significant differences in any outcome variable between the two treatments. For both CP and CIFC the pain intensity improved (P<0.0001) whereas the NDI was unchanged at long-term follow-up compared to preoperatively. In the CIFC group patients with a healed fusion had significantly less mean pain (24xa0mm) and NDI (26%) than patients with pseudarthrosis (42 and 41, respectively). Furthermore, the mean pain and NDI reported by CIFC patients with a healed fusion was significantly less than in healed CP patients (37 and 38, respectively). The long-term outcome is the same for the CIFC and the CP, with similar improvements of pain but with considerable remaining functional disability. However, in the subgroup of patients with healed CIFC the outcome was clearly better than for the non-healed CIFC group, and also clearly better than for the healed CP group. Thus, if the healing problem associated with the CIFC can be solved the results indicate that a better outcome can be expected with the cage than with the CP.

Surgery versus nonsurgical treatment of cervical radiculopathy : A prospective, randomized study comparing surgery plus physiotherapy with physiotherapy alone with a 2-year follow-up

Study Design. Prospective randomized controlled trial. Objective. To study the outcome of anterior cervical decompression and fusion combined with a structured physiotherapy program compared with the same physiotherapy program alone for patients with cervical radiculopathy. Summary of Background Data. Knowledge concerning the effects of interventions for patients with cervical radiculopathy is scarce due to a lack of randomized studies. Methods. Sixty-three patients were randomized to surgery with postoperative physiotherapy (n = 31) or physiotherapy alone (n = 32). The surgical group was treated with anterior cervical decompression and fusion. The physiotherapy program included general/specific exercises and pain-coping strategies. The outcome measures were disability (Neck Disability Index), neck and arm pain intensity (visual analogue scale), and the patients global assessment. Patients were followed for 24 months. Results. The result from the repeated-measures analysis of variance showed no significant between-group difference for Neck Disability Index (P = 0.23). For neck pain intensity, the repeated-measures analysis of variance showed a significant between-group difference during the study period in favor of the surgical group (P = 0.039). For arm pain intensity, no significant between-group differences were found according to the repeated-measures analysis of variance (P = 0.580). Eighty-seven percent of the patients in the surgical group rated their symptoms as “better/much better” at the 12-month follow-up compared with 62% in the nonsurgical group (P < 0.05). At 24 months, the corresponding figures were 81% and 69% (P = 0.28). The difference was significant only at the 12-month follow-up in favor of the surgical group. Significant reduction in Neck Disability Index, neck pain, and arm pain compared with baseline was seen in both groups (P < 0.001). Conclusion. In this prospective, randomized study of patients with cervical radiculopathy, it was shown that surgery with physiotherapy resulted in a more rapid improvement during the first postoperative year, with significantly greater improvement in neck pain and the patients global assessment than physiotherapy alone, but the differences between the groups decreased after 2 years. Structured physiotherapy should be tried before surgery is chosen. Level of Evidence: 2

Disability after Anterior Decompression and Fusion for Cervical Disc Disease

Few prospective studies on outcome have been conducted with respect to disability after anterior cervical decompression and fusion (ACDF), and the need for further rehabilitation after surgery is unknown. Thirty-four patients with cervical disc disease verified by magnetic resonance imaging were included before ACDF with a cervical carbon fibre intervertebral fusion cage. Measurements took place the day before, 6 months and 1 year after surgery, and consisted of both objective and subjective measurements. The results showed a significant improvement from surgery in neck muscle endurance in flexion, neck strength in lateral flexion, some of the pain variables, numbness, neck specific disability, change in general health and symptom satisfaction at the 1-year follow-up. Except for worsening in general health, there were no significant differences between the 6-month and the 1-year follow-up. Despite improvement in several of the variables, about one-third of the patients had deficits in the objective measurements and about two-thirds had deficits in the subjective variables. Only five patients were without neck problems according to average pain, the Neck Disability Index and general health. This suggests that there is still a great need for improvement both of the surgical procedure and the rehabilitation afterwards.

The Discover artificial disc replacement versus fusion in cervical radiculopathy—a randomized controlled outcome trial with 2-year follow-up

BACKGROUND CONTEXTnSeveral previous studies comparing artificial disc replacement (ADR) and fusion have been conducted with cautiously positive results in favor of ADR. This study is not, in contrast to most previous studies, an investigational device exemption study required by the Food and Drug Administration for approval to market the product in the United States. This study was partially funded with unrestricted institutional research grants by the company marketing the artificial disc used in this study.nnnPURPOSEnTo compare outcomes between the concepts of an artificial disc to treatment with anterior cervical decompression and fusion (ACDF) and to register complications associated to the two treatments during a follow-up time of 2 years.nnnSTUDY DESIGN/SETTINGnThis is a randomized controlled multicenter trial, including three spine centers in Sweden.nnnPATIENT SAMPLEnThe study included patients seeking care for cervical radiculopathy who fulfilled inclusion criteria. In total, 153 patients were included.nnnOUTCOME MEASURESnSelf-assessment with Neck Disability Index (NDI) as a primary outcome variable and EQ-5D and visual analog scale as secondary outcome variables.nnnMETHODSnPatients were randomly allocated to either treatment with the Depuy Discover artificial disc or fusion with iliac crest bone graft and plating. Randomization was blinded to both patient and caregivers until time for implantation. Adverse events, complications, and revision surgery were registered as well as loss of follow-up.nnnRESULTSnData were available in 137 (91%) of the included and initially treated patients. Both groups improved significantly after surgery. NDI changed from 63.1 to 39.8 in an intention-to-treat analysis. No statistically significant difference between the ADR and the ACDF groups could be demonstrated with NDI values of 39.1 and 40.1, respectively. Nor in secondary outcome measures (EQ-5D and visual analog scale) could any statistically significant differences be demonstrated between the groups. Nine patients in the ADR group and three in the fusion group underwent secondary surgery because of various reasons. Two patients in each group underwent secondary surgery because of adjacent segment pathology. Complication rates were not statistically significant between groups.nnnCONCLUSIONSnArtificial disc replacement did not result in better outcome compared to fusion measured with NDI 2 years after surgery.

Physical Function Outcome in Cervical Radiculopathy Patients After Physiotherapy Alone Compared With Anterior Surgery Followed by Physiotherapy A Prospective Randomized Study With a 2-Year Follow-up

Study Design. Prospective randomized study. Objective. To investigate differences in physical functional outcome in patients with radiculopathy due to cervical disc disease, after structured physiotherapy alone (consisting of neck-specific exercises with a cognitive-behavioral approach) versus after anterior cervical decompression and fusion (ACDF) followed by the same structured physiotherapy program. Summary of Background Data. No earlier studies have evaluated the effectiveness of a structured physiotherapy program or postoperative physical rehabilitation after ACDF for patients with magnetic resonance imaging–verified nerve compression due to cervical disc disease. Methods. Our prospective randomized study included 63 patients with radiculopathy and magnetic resonance imaging–verified nerve root compression, who were randomized to receive either ACDF in combination with physiotherapy or physiotherapy alone. For 49 of these patients, an independent examiner measured functional outcomes, including active range of neck motion, neck muscle endurance, and hand-related functioning before treatment and at 3-, 6-, 12-, and 24-month follow-ups. Results. There were no significant differences between the 2 treatment alternatives in any of the measurements performed (P = 0.17–0.91). Both groups showed improvements over time in neck muscle endurance (P ⩽ 0.01), manual dexterity (P ⩽ 0.03), and right-handgrip strength (P = 0.01). Conclusion. Compared with a structured physiotherapy program alone, ACDF followed by physiotherapy did not result in additional improvements in neck active range of motion, neck muscle endurance, or hand-related function in patients with radiculopathy. We suggest that a structured physiotherapy program should precede a decision for ACDF intervention in patients with radiculopathy, to reduce the need for surgery. Level of Evidence: 2

A comparison between the carbon fiber cage and the cloward procedure in cervical spine surgery: a ten- to thirteen-year follow-up of a prospective randomized study.

Study Design. Ten- to 13-year follow-up of a prospective randomized study. Objective. To compare the 10- to 13-year outcomes of anterior cervical decompression and fusion (ACDF) with a cervical intervertebral fusion cage (CIFC), and the Cloward procedure (CP) using a broad clinical and patient-centered assessment. Summary of Background Data. There are few prospective studies and none with a follow-up of 10 years or more. Methods. Patient questionnaires completed 10 years or more after ACDF. Seventy-three patients (77%) responded. Radiographs were obtained at 2 years. Results. Apart from greater fulfillment of preoperative expectation (P = 0.01) and less headache (P = 0.005) in the CIFC group compared with the CP group, there were no significant differences in the outcomes of the two surgical methods. Pain intensity improved in comparison with preoperative levels in both the CIFC and CP groups (P < 0.0001), but the Neck Disability Index (NDI) only improved in the CIFC group (P = 0.04). Only those with a healed fusion benefited from an improved NDI (P = 0.02). There was no deterioration in pain intensity or NDI after the 2-year follow-up. Conclusion. The outcomes of the two surgical methods, with a few exceptions, were equal at 10- to 13-year follow-up, and there was no deterioration in outcome after the 2-year follow-up. Pain intensity improved more than disability, which may indicate that further improvement of physical function requires early more extensive postoperative rehabilitation. Despite persisting disability, repeat surgery was relatively uncommon.