The Clinical Relevance of the Cervical Disc Prosthesis: Combining Clinical Results of Two RCTs.

STUDY DESIGN: Retrospective analysis was performed on data from 251 patients that were included in two randomized, double-blinded clinical trials comparing clinical results of anterior cervical discectomy and arthroplasty (ACDA) to anterior cervical discectomy and fusion (ACDF), and anterior cervical discectomy (ACD), for single-level disc herniation. OBJECTIVE: This study aimed to investigate whether the ACDA procedure offers superior clinical results 2 years after surgery, to either ACDF or ACD without instrumentation, in the entire group of patients or in a particular subgroup of patients. SUMMARY OF BACKGROUND DATA: The cervical disc prosthesis was introduced to provide superior clinical outcomes after ACD. METHODS: Neck Disability Index (NDI), and subscales of the 36-item short-form health survey (SF-36) and McGill pain score were collected at baseline, 1 year and 2 years after surgery. Reoperations and complications were also evaluated. A preliminary subgroup analysis was performed for age, disc height, body mass index (BMI), smoking, and sex. RESULTS: The NDI decreased comparably in all treatment arms to circa 50% of the baseline value and marginal mean NDI differences varied from 0.4 to 1.1 on a 100 point NDI scale, with confidence intervals never exceeding the 20-point minimal clinical important difference (MCID). Secondary outcome parameters showed comparable results. Preliminary subgroup analysis could not demonstrate clinically relevant differences in NDI between treatments after 2 years. CONCLUSION: After combining data from two Randomized Controlled Trials it can be concluded that there is no clinical benefit for ACDA, when compared with ACDF or ACD 2 years after surgery. Preliminary subgroup analysis indicated outcomes were similar between treatment groups, and that no subgroup could be appointed that benefited more from either ACD, ACDF, or ACDA.Level of Evidence: 1.

Prosthesis in Anterior Cervical Herniated Disc Approach Does Not Prevent Radiologic Adjacent Segment Degeneration.

STUDY DESIGN: Retrospective analysis using data from RCTs. OBJECTIVE: This study aimed to report on the incidence of radiological adjacent segment degeneration (ASD) in patients with cervical radiculopathy due to a herniated disc that were randomized to receive cervical arthroplasty or arthrodesis. SUMMARY OF BACKGROUND DATA: Cervical disc prostheses were introduced to prevent ASD in the postsurgical follow-up. However, it is still a controversial issue. METHODS: Two hundred fifty-three patients were included in two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF), or without intervertebral cage (ACD) for one-level disc herniation. Neutral lateral radiographs were obtained preoperatively, at 1- and 2-year follow-up after surgery. Radiological ASD was evaluated on X-ray and defined by a decrease in disc height and the presence of anterior osteophyte formation on both the superior and the inferior level in relation to the target level. RESULTS: Radiological ASD was present in 34% of patients at baseline and increased to 59% at 2-year follow-up in the arthrodesis groups (ACD and ACDF combined), and to 56% in the arthroplasty group. Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up. CONCLUSIONS: Radiological ASD occurs in a similar manner in patients who were subjected to arthrodesis in cervical radiculopathy and in patients who received arthroplasty to maintain motion. Current data tend to indicate that the advantage of cervical prosthesis in preventing radiological ASD is absent. LEVEL OF EVIDENCE: 2.

Comparing Heterotopic Ossification in Two Cervical Disc Prostheses.

STUDY DESIGN: Retrospective analysis using data from randomized clinical trials. OBJECTIVE: To compare the occurrence of heterotopic ossification (HO) between two cervical disc prostheses. Clinical outcome and range of motion (ROM) were also evaluated. SUMMARY OF BACKGROUND DATA: Cervical arthroplasty was reported to be able to maintain the segmental ROM. However, controversy exists since the difference of the occurrence of HO concerning cervical prosthesis is still huge. METHODS: Patients who underwent anterior cervical discectomy with arthroplasty for a cervical radiculopathy due to a herniated disc from the The Netherlands Cervical Kinematics (NECK) trial (activC; metal endplates with a polyethylene inlay and a keel for primary stability) and the PROCON trial (Bryan; metal-on-polymer with titanium coated endplates without a keel) were analyzed for HO at 12 and 24 months postoperatively. HO was scored according to the McAfee-Mehren classification. Segmental ROM was defined by a custom developed image analysis tool, and global cervical ROM was measured by Cobb's angle. Clinical outcome was evaluated by means of the neck disability index (NDI) as well as physical-component summary (PCS) and mental-component summary (MCS). RESULTS: At 2-year follow-up, the occurrence of HO was 68% in patients treated with the activC prosthesis (severe HO 55%), which was comparable with 85% (P = 0.12) in patients with the Bryan disc (severe HO 44%; P = 0.43). The HO progression was similar between groups. Clinically, the patients had comparable NDI, PCS, and MCS at 2-year follow-up, and comparable improvement of clinical outcomes. The global ROM in the Bryan group (56.4 ±â€Š10.8°) was significantly higher than in the activC group (49.5 ±â€Š14.0, P = 0.044) at 2-year follow-up. CONCLUSION: In comparison of two cervical disc prostheses the development of HO is independent on their architecture. Although global ROM was higher in the Bryan prosthesis group, this difference was not deemed clinically important, particularly because the clinical condition of patients with and without severe HO was comparable. LEVEL OF EVIDENCE: 2.

The association of cervical sagittal alignment with adjacent segment degeneration.

PURPOSE: Cervical spine surgery may affect sagittal alignment parameters and induce accelerated degeneration of the cervical spine. Cervical sagittal alignment parameters of surgical patients will be correlated with radiological adjacent segment degeneration (ASD) and with clinical outcome parameters. METHODS: Patients were analysed from two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF) and without intervertebral cage (ACD). C2-C7 lordosis, T1 slope, C2-C7 sagittal vertical axis (SVA) and the occipito-cervical angle (OCI) were determined as cervical sagittal alignment parameters. Radiological ASD was scored by the combination of decrease in disc height and anterior osteophyte formation. Neck disability index (NDI), SF-36 PCS and MCS were evaluated as clinical outcomes. RESULTS: The cervical sagittal alignment parameters were comparable between the three treatment groups, both at baseline and at 2-year follow-up. Irrespective of surgical method, C2-C7 lordosis was found to increase from 11° to 13°, but the other parameters remained stable during follow-up. Only the OCI was demonstrated to be associated with the presence and positive progression of radiological ASD, both at baseline and at 2-year follow-up. NDI, SF-36 PCS and MCS were demonstrated not to be correlated with cervical sagittal alignment. Likewise, a correlation with the value or change of the OCI was absent. CONCLUSION: OCI, an important factor to maintain horizontal gaze, was demonstrated to be associated with radiological ASD, suggesting that the occipito-cervical angle influences accelerated cervical degeneration. Since OCI did not change after surgery, degeneration of the cervical spine may be predicted by the value of OCI. NECK TRIAL: Dutch Trial Register Number NTR1289. PROCON TRIAL: Trial Register Number ISRCTN41681847. These slides can be retrieved under Electronic Supplementary Material.

Does Heterotopic Ossification in Cervical Arthroplasty Affect Clinical Outcome?

OBJECTIVE: To investigate the occurrence and progression of heterotopic ossification (HO) in patients treated by anterior cervical discectomy with arthroplasty. It was evaluated if HO affects clinical outcome and range of motion (ROM). Risk factors of HO was studied as well. METHODS: Patients who underwent anterior cervical discectomy with arthroplasty for a cervical radiculopathy because of a herniated disc from the NECK and PROCON trial were analyzed for HO at 12 and 24 months postoperatively. HO was scored according to the McAfee-Mehren classification. The index ROM was defined by a custom developed image analysis tool, and global cervical ROM was measured by Cobb's angle. Clinical outcome was evaluated by means of the Neck Disability Index and the 36-Item Short Form Health Survey. RESULTS: The occurrence of HO was 60% at 1 year, and it increased to 76% at 2-year follow-up. A total of 31% of patients were scored as high-grade HO at 1-year follow-up, and this percentage increased to 50% at 2-year follow-up. Clinical outcome does not correlate to HO grade, and no risk factor for high-grade HO could be identified. The ROM at the index level was significantly higher in low-grade HO group than those patients with high-grade HO, but in 15%-38% HO grade does not correspond to ROM. CONCLUSIONS: HO occurs in three fourths of the patients at 2 years after surgery, but does not necessarily correspond to clinical outcome, nor loss or preservation of ROM. The McAfee-Mehren classification should be combined with ROM evaluation to properly study HO.

Maintaining range of motion after cervical discectomy does not prevent adjacent segment degeneration.

BACKGROUND: Motion preservation prostheses were introduced to prevent adjacent disc degeneration (ASD) and to diminish neck disability in the postsurgical follow-up. However, it is still a controversial issue, and the relationship between range of motion (ROM) and ASD has not been studied. PURPOSE: To compare the correlation between ROM of the cervical spine and the presence of radiological ASD after anterior discectomy. Clinical outcome was also correlated to ROM and ASD. STUDY DESIGN: Retrospective cohort study. METHODS: In all, 253 patients who underwent anterior discectomy for cervical radiculopathy due to a herniated disc were analyzed for segmental and global cervical ROM and the presence of ASD both preoperatively, and 12 and 24 months postoperatively. Patients who were included in two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty, anterior cervical discectomy with intervertebral cage, or anterior cervical discectomy without intervertebral cage for one level disc herniation were analyzed. ROM was defined by a custom-developed image analysis tool. ASD was defined by decrease in disc height and anterior osteophyte formation on X-rays. Clinical outcome was evaluated by means of the Neck Disability Index (NDI). RESULTS: Two years postoperatively, no correlation was demonstrated between ROM and ASD. The incidence of ASD was comparable in the three groups, being 34% at baseline, and 58% at 2-year follow-up. Likewise, ASD progression was comparable in the three treatment arms. No correlation was demonstrated between ROM and NDI or ASD and NDI. CONCLUSIONS: Since ROM is not correlated to ASD, and clinical outcome is not correlated to ROM either, the relevance of continued ROM at the target level seems absent.

Are Modic Vertebral End-Plate Signal Changes Associated with Degeneration or Clinical Outcomes in the Cervical Spine?

OBJECTIVE: To report on the incidence of Modic changes (MCs) in patients with cervical radiculopathy due to a herniated disc. Presence of MCs was correlated to clinical outcomes and the presence of radiological degeneration. METHODS: Patients that underwent anterior discectomy for a cervical radiculopathy due to a herniating disc were analyzed for the presence of MCs at baseline and at 1-year follow-up after surgery. Neck Disability Index, physical component summary, mental component summary, and visual analog scale for neck pain and for arm pain were evaluated as clinical outcomes. The presence of radiological degeneration was defined by the method of Goffin. RESULTS: The prevalence of MCs was found at 18% at baseline and increased to 28% one year after surgery. Both at baseline and at 1-year follow-up, the percentage of patients with and without MCs reporting neck pain was comparable. Likewise, both at baseline and at 1-year follow-up, the percentage of patients with and without MCs reporting disabling arm pain was comparable. At baseline, the patients with MC demonstrated more radiologic degeneration than those without MC (OR 0.42), but this difference disappeared at 1 year after surgery. CONCLUSIONS: MCs were not associated with neck pain, nor with arm pain. Furthermore, there was a tendency for a correlation between the presence of MCs and radiological degeneration.

Substantial clinical benefit for Neck Disability Index revisited: establishing the goal for treatment?

PURPOSE: It is difficult for clinicians to inform patients about the success rate of a treatment as a cervical anterior discectomy procedure. Ideally, a proportion of good outcome as rated by patients is known. Patient-reported outcome measurements are helpful. The purpose is to relate the difference in Neck Disability Index (NDI) after a cervical anterior discectomy procedure for single level cervical degenerative disc disease with the patients' rating of their actual clinical situation after long-term follow-up to define the substantial clinical benefit (SCB). METHODS: After completion of the NDI, patients who were surgically treated for cervical single level degenerative disease were asked to complete a five-item Likert scale to rate their clinical situation. After dichotomisation of the outcome in good versus less than good, a cut-off value was defined by determining the value of the difference of NDI with the highest specificity and sensitivity. Funding was not obtained. RESULTS: SCB for NDI after surgery for cervical single level degenerative disease should be set at ten with area under the curve (AUC) of 0.71 for sensitivity as well specificity. CONCLUSIONS: The goal for each treatment is a good outcome. While comparing treatments for cervical degenerative disc disease only those with an SCB of ten will be relevant for the patient, as patients who achieved this difference in NDI rated their actual situation at long-term follow-up as good.

Symptomatic Adjacent Segment Disease After Anterior Cervical Discectomy for Single-level Degenerative Disk Disease.

STUDY DESIGN: A prospective cohort of 142 patients underwent either anterior cervical discectomy alone, anterior cervical discectomy with fusion by cage stand-alone, or anterior cervical discectomy with arthroplasty. We then followed up on their condition for a mean of 9.1±1.9 years (5.6-12.2 y) later. OBJECTIVE: We aimed to evaluate the annual rate of clinically symptomatic adjacent segment disease (ASD) and to analyze predictive factors. SUMMARY OF BACKGROUND DATA: Until recent, ASD has been predominantly evaluated radiologically. It is not known whether all patients had complaints. A frequent cited annual rate of ASD is 2.9%, but a growing number of studies report a lower annual rate. Furthermore, maintaining motion to prevent ASD is one reason for implanting a cervical disk prosthesis. However, the results of studies contradict one another. METHODS: Participants took part in a randomized controlled trial that ended prematurely because of the publication of evidence that did not justify continuation of the trial. The patients were randomly allocated to 3 groups, each of which received one of the abovementioned treatments. We defined symptomatic ASD as signs and symptoms caused by degeneration of an intervertebral disk adjacent to a level of previous anterior cervical disk surgery. At the last follow-up, we were able to ascertain whether clinically symptomatic ASD was present in any of the participants. RESULTS: The overall annual rate of symptomatic ASD was 0.7%. We found no statistically significant correlations between any of the investigated factors and symptomatic ASD except for the surgical method used. Symptomatic ASD was seen less often in anterior cervical discectomy solely or anterior cervical discectomy with arthroplasty than in anterior cervical discectomy with fusion by plate fixation. CONCLUSIONS: The annual rate of symptomatic ASD after an anterior cervical discectomy procedure was estimated to be 0.7%. This seems to be related to the procedure, although firm conclusions cannot be drawn. LEVEL OF EVIDENCE: Level 2-prospective cohort.

Cervical sagittal alignment after different anterior discectomy procedures for single-level cervical degenerative disc disease: randomized controlled trial.

BACKGROUND: The effect of anterior cervical discectomy without fusion (ACD), ACD with fusion by stand-alone cage (ACDF) or with arthroplasty (ACDA) on cervical sagittal alignment is not known and is the subject of this study. METHODS: A total of 142 adult patients with single-level cervical disease were at random allocated to different procedures: ACD (45), ACDF (47) and ACDA (50). Upright cervical spine radiographs were obtained. Angles of the involved angle and the angle between C2 and C7 were determined. RESULTS: After a mean follow-up of 25.4 ± 18.4 months, the angles of the involved level comparing ACD with ACDA and ACD with ACDF were different, reaching statistical significance. However, the angle between C2 and C7 did not differ between groups or between preoperative values and at follow-up. CONCLUSIONS: Irrespective of the technique used for anterior cervical discectomy for single-level degenerative disc disease, the alignment of the cervical spine is unaltered.

What's the best surgical treatment for patients with cervical radiculopathy due to single-level degenerative disease? A randomized controlled trial.

BACKGROUND: To investigate the efficacy of adding supplemental fusion or arthroplasty after cervical anterior discectomy for symptomatic mono-level cervical degenerative disease (radiculopathy), which has not been substantiated in controlled trials until now. METHODS: A randomized controlled trial is reported with 9 years follow up comparing anterior cervical anterior discectomy without fusion, with fusion by cage standalone, or with disc prosthesis. Patients suffering from symptomatic cervical disk degeneration at one level referred to spinal sections of department of neurosurgery or orthopedic surgery of a large general hospital with educational facilities were eligible. Neck Disability Index (NDI), McGill Pain Questionnaire Dutch language version (MPQ-DLV), physical-component summary (PCS), and mental-component summary (MCS) of the 36-item Short-Form Health Survey (SF-36), and re operation rate were evaluated. FINDINGS: 142 patients between 18 and 55 years were allocated. The median follow-up was 8.9±1.9 years (5.6 to 12.2 years). The response rate at last follow-up was 98.5%. NDI at the last follow-up did not differ between the three treatment groups, nor did the secondary outcomes as MPQ-DLV and PCS or MCS from SF-36. The major improvement occurred within the first 6 weeks after surgery. Afterward, it remained stable. Eleven patients underwent surgery for recurrent symptoms and signs due to nerve root compression at the index or adjacent level. CONCLUSIONS: This randomized trial could not detect a difference between three surgical modalities for treating a single-level degenerative disk disease. Anterior cervical discectomy without implant seems to be similar to anterior cervical discectomy with fusion by cage stand-alone or with disk prosthesis. Due to the small study sample size, this statement should be considered as inconclusive so far. TRIAL REGISTRATION: ISRCTN41681847.

Reporting the results of meta-analyses: a plea for incorporating clinical relevance referring to an example.

BACKGROUND CONTEXT: The results of meta-analyses are frequently reported, but understanding and interpreting them is difficult for both clinicians and patients. Statistical significances are presented without referring to values that imply clinical relevance. PURPOSE: This study aimed to use the minimal clinically important difference (MCID) to rate the clinical relevance of a meta-analysis. STUDY DESIGN: This study is a review of the literature. PATIENT SAMPLE: This study is a review of meta-analyses relating to a specific topic, clinical results of cervical arthroplasty. OUTCOME MEASURE: The outcome measure used in the study was the MCID. METHODS: We performed an extensive literature search of a series of meta-analyses evaluating a similar subject as an example. We searched in Pubmed and Embase through August 9, 2016, and found articles concerning meta-analyses of the clinical outcome of cervical arthroplasty compared with that of anterior cervical discectomy with fusion in cases of cervical degenerative disease. We evaluated the analyses for statistical significance and their relation to MCID. MCID was defined based on results in similar patient groups and a similar disease entity reported in the literature. RESULTS: We identified 21 meta-analyses, only one of which referred to MCID. However, the researchers used an inappropriate measurement scale and, therefore, an incorrect MCID. The majority of the conclusions were based on statistical results without mentioning clinical relevance. CONCLUSIONS: The majority of the articles we reviewed drew conclusions based on statistical differences instead of clinical relevance. We recommend introducing the concept of MCID while reporting the results of a meta-analysis, as well as mentioning the explicit scale of the analyzed measurement.

An assessment of the most reliable method to estimate the sagittal alignment of the cervical spine: analysis of a prospective cohort of 138 cases.

OBJECTIVE Although there is increasing recognition of the importance of cervical spinal sagittal balance, there is a lack of consensus as to the optimal method to accurately assess the cervical sagittal alignment. Cervical alignment is important for surgical decision making. Sagittal balance of the cervical spine is generally assessed using one of two methods; namely, measuring the angle between C-2 and C-7, and drawing a line between C-2 and C-7. Here, the best method to assess sagittal alignment of the cervical spine is investigated. METHODS Data from 138 patients enrolled in a randomized controlled trial (Procon) were analyzed. Two investigators independently measured the angle between C-2 and C-7 by using Harrison's posterior tangent method, and also estimated the shape of the sagittal curve by using a modified Toyama method. The mean angles of each quantitative assessment of the sagittal alignment were calculated and the results were compared. The interrater reliability for both methods was estimated using Cronbach's alpha. RESULTS For both methods the interrater reliability was high: for the posterior tangent method it was 0.907 and for the modified Toyama technique it was 0.984. For a lordotic cervical spine, defined by the modified Toyama method, the mean angle (defined by Harrison's posterior tangent method) was 23.4° ± 9.9° (range 0.4°-52.4°), for a kyphotic cervical spine it was -2.2° ± 9.2° (range -16.1° to 16.9°), and for a straight cervical spine it was 10.5° ± 8.2° (range -11° to 36°). CONCLUSIONS An absolute measurement of the angle between C-2 and C-7 does not unequivocally define the sagittal cervical alignment. As can be seen from the minimum and maximum values, even a positive angle between C-2 and C-7 could be present in a kyphotic spine. For this purpose, the modified Toyama method (drawing a line from the posterior inferior part of the vertebral body of C-2 to the posterior upper part of the vertebral body of C-7 without any measurements) is a better tool for a global assessment of cervical sagittal alignment. Clinical trial registration no.: ISRCTN41681847 ( https://www.isrctn.com ).

The Qualification of Outcome after Cervical Spine Surgery by Patients Compared to the Neck Disability Index.

OBJECTIVE: The Neck Disability Index (NDI) is a patient self-assessed outcome measurement tool to assess disability, and that is frequently used to evaluate the effects of the treatment of neck-related problems. In individualized medicine it is mandatory that patients can interpret data in order to choose a treatment. A change of NDI or an absolute NDI is generally meaningless to a patient. Therefore, a correlation between the qualification of the clinical situation rated by the patient and the NDI score was evaluated. METHODS: Patients who completed an NDI after anterior surgery because of symptomatic single level degenerative cervical disc disease were asked one month after completion of the NDI to qualify their clinical situation of a 5-item Likert scale varying from excellent to bad. Since a clear distinction between the categories was not possible based on the total NDI score, a ROC-curve was built, and the AUC computed in order to estimate best dichotomization in qualification of the clinical situation. The best corresponding cut-off point for the NDI total score was found by studying sensitivity and specificity for all possible cut-off points. RESULTS: 102 patients were included. The highest AUC was obtained by dichotomizing the qualification into a group with good outcome and less-good outcome. The highest sensitivity and specificity for the dichotomized qualification as good outcome corresponded to a NDI ≤ 7. Sensitivity was 81.08% and specificity was 78.57%. CONCLUSION: This is the first study that correlated the qualification of the situation by the patients themselves and NDI. An NDI ≤ 7 corresponded to a good outcome according to the patients. This is valuable information to inform patients in their decision for any treatment.

No justification for cervical disk prostheses in clinical practice: a meta-analysis of randomized controlled trials.

OBJECTIVE: A meta-analysis was performed to evaluate whether a beneficial clinical effect of cervical disk prostheses over conventional cervical diskectomy with fusion exists. METHODS: A literature search was completed ending February 4, 2009, that included the abstract books of recent major spine congresses. All studies reported the results of single-level cervical disease without myelopathy. The Visual Analog Score (VAS) of the arm, VAS of the neck, Neck Disability Index, Physical Composite Scores of the Short Form 36, and Mental Composite Score of the Short Form 36, as well as adverse events, were evaluated. RESULTS: Nine records were found, totaling 1533 patients. Of these, 1165 were evaluable at the last follow-up at 12 or 24 months. As an effect measure, a pooled odds ratio (OR) was calculated at 12 and 24 months. At 12 months, the VAS arm reached statistical significance (OR = 0.698; 95% confidence interval [CI], 0.571-0.853), as did the VAS neck (OR = 0.690; 95% CI, 0.562-0.847), and the Physical Composite Scores (OR = 1.362; 95% CI, 1.103-1.682) and the Mental Composite Score (OR = 1.270; 95% CI, 1.029-1.569) of the Short Form 36, favoring arthroplasty. The Neck Disability Index at 24 months also reached statistical difference (OR = 0.794; 95% CI, 0.641-0.984). All other measurements did not reveal any statistical difference. The number of complications, including secondary surgeries for adjacent segment disease, did not differ. CONCLUSION: A clinical benefit for the cervical disk prosthesis is not proven. Because none of the studies were blinded, bias of the patient or researcher is a probable explanation for the differences found. Therefore, these costly devices should not be used in daily clinical practice.

Comparison of biomechanical properties of cervical artificial disc prosthesis: a review.

Cervical artificial discs are frequently implanted. Clinical data are frequently presented. However, biomechanical data are scarce. The literature is extensively reviewed following general rules for systemic review. The manufacturers of cervical artificial discs are requested for information. Only 10 articles were suitable for review. Together with some information of the manufacturer, data of 5 out of 8 discs can be provided. Comparison is not possible since testing methods differ. Before introduction of a new device biomechanical data should be provided. This should be done after standardized testing and presentation of the results. Only then comparison is possible as is a responsible choice for our patients.

Self-rated evaluation of outcome of the implantation of interspinous process distraction (X-Stop) for neurogenic claudication.

The treatment of lumbar spinal stenosis is either conservative or surgical decompression. Recently, an interspinous decompression device (X-Stop) has been developed as an alternative. Patients treated with an X-Stop between 2003 and 2006 are subject of this study. The SF-36 Health Survey and Zürich Questionnaires are used. The data of pre- and post-operative self-rated questionnaires are collected and analysed by independent investigators. The data were statistically analysed. A good outcome was defined when the mean score at the ZQ for satisfaction was at maximal 2.0, and the mean improvement of the severity score was at least 0.5, and also for vitality score. For relations between outcome and gender, smoking, BMI, orthopaedic co-morbidity, number of implanted X-Stops were sought. The change in SF-36 scales was related to the outcome. Sixty-five patients did undergo implantation of an X-Stop. The mean age was 64.4 +/- 10.0 years (range: 37.0-85.0 years). 31.1% Of the patients had a good outcome. A good outcome was not related to smoking, BMI, number of implanted X-Stops. However, a good outcome was related to the absence of orthopaedic co-morbidity or male gender. Patients with a good outcome had significantly a better improvement of the scales of the SF-36 concerning physical pain or impairment. The X-Stop does improve the clinical situation. However, a good outcome is achieved less often than previously reported. Probable explanations are discussed.

The trochlea is medialized by total knee arthroplasty: an intraoperative assessment in 61 patients.

BACKGROUND: A medialization of the femoral component in a total knee arthroplasty (TKA) causes abnormal patellar tracking, which could result in patellar instability, pain, wear, and failure. Previous reports defined medialization in relation to the neutral position of the femoral component, but omitted to compare it to the anatomical position of the trochlea. We assessed intraoperatively whether there is a systematic error of the position of the prosthetic groove relative to the anatomical trochlea. MATERIAL AND METHODS: A special instrument was developed to measure consecutively the mediolateral position of the anatomical trochlea and the mediolateral position of the prosthetic groove. 3 experienced knee surgeons determined the mediolateral error of the prosthetic groove in primary TKAs in 61 patients. RESULTS: There was a significant medial error of the prosthetic groove relative to the preoperative position of the trochlea, with a mean medial error of 2.5 mm (SD 3.3) INTERPRETATION: Our findings indicate that the trochlea is medialized by TKA. Because a conscious medialization of the femoral component in a TKA produces abnormal patellar tracking patterns, further investigations will be needed to analyze the clinical consequences of this medialization of the trochlea.

Design of the PROCON trial: a prospective, randomized multi-center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty.

BACKGROUND: PROCON was designed to assess the clinical outcome, development of adjacent disc disease and costs of cervical anterior discectomy without fusion, with fusion using a stand alone cage and implantation of a Bryan's disc prosthesis. Description of rationale and design of PROCON trial and discussion of its strengths and limitations. METHODS/DESIGN: Since proof justifying the use of implants or arthroplasty after cervical anterior discectomy is lacking, PROCON was designed. PROCON is a multicenter, randomized controlled trial comparing cervical anterior discectomy without fusion, with fusion with a stand alone cage or with implantation of a disc. The study population will be enrolled from patients with a single level cervical disc disease without myelopathic signs. Each treatment arm will need 90 patients. The patients will be followed for a minimum of five years, with visits scheduled at 6 weeks, 3 months, 12 months, and then yearly. At one year postoperatively, clinical outcome and self reported outcomes will be evaluated. At five years, the development of adjacent disc disease will be investigated. DISCUSSION: The results of this study will contribute to the discussion whether additional fusion or arthroplasty is needed and cost effective.

Subsidence of stand-alone cervical carbon fiber cages.

OBJECTIVE: To investigate the number of subsidences of inserted cervical carbon fiber cages and to define predictive factors for subsidence. METHODS: All patients treated for a cervical herniated disc and fusion with a cervical carbon fiber cage between January 2002 and December 2003 were retrospectively identified. The radiological examinations were reviewed, and, especially, the presence of subsidence was noted. Possible predictive factors for subsidence were determined before the investigation. RESULTS: In 69 patients, there were 96 cages inserted, of which 29.2% subsided. Of all factors investigated, only smoking seemed to be predictive for subsidence, whereas insertion at C6 to C7 clearly had a higher risk at subsidence. Subsidence was not related to outcome or fusion. CONCLUSION: Although the high number of subsidence of cages has never been described before, clinical outcome and fusion rate is comparable with the literature.