Effects of the Balanced Gap Technique on Femoral Component Rotation in TKA

Femoral component rotation from a total knee prosthesis can be determined by either a measured resection technique or a balanced gap technique. With the balanced gap implantation technique, femoral component rotation can vary freely within the restrictions produced by soft tissue structures. Because internal rotation might cause patella problems, the effect of ligament releases on femoral component rotation in a prospective clinical study was studied. Femoral component rotation was measured intraoperatively with a tensor applied in flexion at 150 N in 87 knees. Great interpatient variability was found; femoral component rotation, reference from the posterior condyles, ranged from −4° to 13°. There was no difference in femoral component rotation of knees with or without ligament releases in extension. However, knees with major medial release had less external femoral component rotation than knees with minor lateral releases. Preoperative alignment had no influence on femoral component rotation. The use of the balanced gap implantation technique theoretically will result in a balanced flexion gap, but the amount of femoral component rotation will be variable owing to patient variability and variation in ligament releases

Surgery versus conservative management of sciatica due to a lumbar herniated disc: a systematic review

The effectiveness of surgery in patients with sciatica due to lumbar disc herniations is not without dispute. The goal of this study was to assess the effects of surgery versus conservative therapy (including epidural injections) for patients with sciatica due to lumbar disc herniation. A comprehensive search was conducted in MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro up to October 2009. Randomised controlled trials of adults with lumbar radicular pain, which evaluated at least one clinically relevant outcome measure (pain, functional status, perceived recovery, lost days of work) were included. Two authors assessed risk of bias according to Cochrane criteria and extracted the data. In total, five studies were identified, two of which with a low risk of bias. One study compared early surgery with prolonged conservative care followed by surgery if needed; three studies compared surgery with usual conservative care, and one study compared surgery with epidural injections. Data were not pooled because of clinical heterogeneity and poor reporting of data. One large low-risk-of-bias trial demonstrated that early surgery in patients with 6–12 weeks of radicular pain leads to faster pain relief when compared with prolonged conservative treatment, but there were no differences after 1 and 2 years. Another large low-risk-of-bias trial between surgery and usual conservative care found no statistically significant differences on any of the primary outcome measures after 1 and 2 years. Future studies should evaluate who benefits more from surgery and who from conservative care

Surgery versus conservative management of sciatica due to a lumbar herniated disc: a systematic review

Abstract The effectiveness of surgery in patients with sciatica due to lumbar disc herniations is not without dispute. The goal of this study was to assess the effects of surgery versus conservative therapy (including epidural injections) for patients with sciatica due to lumbar disc herniation. A comprehensive search was conducted in MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro up to October 2009. Randomised controlled trials of adults with lumbar radicular pain, which evaluated at least one clinically relevant outcome measure (pain, functional status, perceived recovery, lost days of work) were included. Two authors assessed risk of bias according to Cochrane criteria and extracted the data. In total, five studies were identified, two of which with a low risk of bias. One study compared early surgery with prolonged conservative care followed by surgery if needed; three studies compared surgery with usual conservative care, and one study compared surgery with epidural injections. Data were not pooled because of clinical heterogeneity and poor reporting of data. One large low-risk-of-bias trial demonstrated that early surgery in patients with 6-12 weeks of radicular pain leads to faster pain relief when compared with prolonged conservative treatment, but there were no differences after 1 and 2 years. Another large low-risk-of-bias trial between surgery and usual conservative care found no statistically significant differences on any of the primary outcome measures after 1 and 2 years. Future studies should evaluate who benefits more from surgery and who from conservative care

Similar outcome after retention or sacrifice of the posterior cruciate ligament in total knee arthroplasty:A systematic review and meta-analysis

Background and purpose - To retain or to sacrifice the posterior cruciate ligament (PCL) in total knee arthroplasty (TKA) remains a matter of discussion. In this systematic review, we wanted to find differences in functional and clinical outcome between the 2 methods. Methods - We conducted a systematic review and meta-analysis including all randomized controlled trials (RCTs) and quasi-RCTs that have compared PCL retention with PCL sacrifice in TKA with a minimum of 1-year follow-up. Primary outcome was range of motion. Secondary outcomes were knee pain and clinical scoring systems that were preferably validated. Quality of evidence was graded using the GRADE approach. All outcomes available for data pooling were used for meta-analysis. Results - 20 studies involving 1,877 patients and 2,347 knees were included. In meta-analysis, the postoperative flexion angle had a mean difference of 2 degrees (95% CI: 0.23-4.0; p = 0.03) and the KSS functional score was 2.4 points higher in favor of PCL sacrifice (95% CI: 0.41-4.3; p = 0.02). There were no statistically significant differences regarding other measured clinical outcomes such as WOMAC, KSS pain, clinical and overall score, HSS score, SF-12, radiolucencies, femoro-tibial angle, and tibial slope. The quality of the studies varied considerably. Risk of bias in most studies was unclear; 5 were judged to have a low risk of bias and 5 to have a high risk of bias. Interpretation - We found no clinically relevant differences between retention and sacrifice of the PCL in TKA, in terms of functional and clinical outcomes. The quality of the studies ranged from moderate to low. Based on the current evidence, no recommendation can be made as to whether to retain or to sacrifice the PCL

Retention versus sacrifice of the posterior cruciate ligament in total knee arthroplasty for treating osteoarthritis

Background The functional and clinical basis on which to choose whether or not to retain the posterior cruciate ligament during total knee arthroplasty surgery remained unclear after a Cochrane systematic review and meta-analysis in 2005, which contained eight clinical trials. Several new trials have been conducted since then. Hence, an update of the review was performed. Objectives Our aim was to assess the benefits and harms of retention compared to sacrifice of the posterior cruciate ligament in total knee arthroplasty in patients with osteoarthritis of the knee. Search methods An extensive search was conducted in CENTRAL, MEDLINE (PubMed), EMBASE, Web of Science, CINAHL, Academic Search Premier, Current Contents Connect and Science Direct. All databases were searched, without any limitations, up to 6 December 2012. References of the articles were checked and citation tracking was performed. Selection criteria Randomised and quasi-randomised controlled trials comparing retention with sacrifice of the posterior cruciate ligament in primary total knee arthroplasty in patients with osteoarthritis of the knee. Data collection and analysis Data were collected with a pre-developed form. Risk of bias was assessed independently by two authors (WV, LB). The level of evidence was graded using the GRADE approach. Meta-analysis was performed by pooling the results of the selected studies, when possible. Subgroup analyses were performed for posterior cruciate ligament retention versus sacrifice using the same total knee arthroplasty design, and for studies using a posterior cruciate ligament retaining or posterior stabilised design, and when sufficient studies were available subgroup analyses were performed for the same brand. Main results Seventeen randomised controlled trials (with 1810 patients and 2206 knees) were found, described in 18 articles. Ten of these were new studies compared to the previous Cochrane Review. One study from the original Cochrane review was excluded. Most new studies compared a posterior cruciate ligament retaining design with a posterior stabilised design, in which the posterior cruciate ligament is sacrificed (a posterior stabilised design has an insert with a central post which can engage on a femoral cam during flexion). The quality of evidence (graded with the GRADE approach) and the risk of bias were highly variable, ranging from moderate to low quality evidence and with unclear or low risk of bias for most domains, respectively. The performance outcome 'range of motion' was 2.4 degrees higher in favour of posterior cruciate ligament sacrifice (118.3 degrees versus 115.9 degrees; 95% confidence interval (CI) of the difference 0.13 to 4.67; P = 0.04), however the results were heterogeneous. On the item 'knee pain' as experienced by patients, meta-analysis could be performed on the Knee Society knee pain score; this score was 48.3 in both groups, yielding no difference between the groups. Implant survival rate could not be meta-analysed adequately since randomised controlled trials lack the longer term follow-up in order to evaluate implant survival. A total of four revisions in the cruciate-retention and four revisions in the cruciate-sacrifice group were found. The well-validated Western Ontario and McMaster Universities osteoarthritis index (WOMAC) total score was not statistically significantly different between the groups (16.6 points for cruciate-retention versus 15.0 points for cruciate-sacrifice). One study reported a patient satisfaction grade (7.7 points for cruciate-retention versus 7.9 points for cruciate-sacrifice on a scale from 0 to 10, 10 being completely satisfied) which did not differ statistically significantly. Complications were distributed equally between both groups. Only one study reported several re-operations other than revision surgery; that is patella luxations, surgical manipulation because of impaired flexion. The mean functional Knee Society Score was 2.3 points higher (81.2 versus 79.0 points; 95% CI of the difference 0.37 to 4.26; P = 0.02) in the posterior cruciate ligament sacrificing group. Results from the outcome Knee Society functional score were homogeneous. All other outcome measures (extension angle, knee pain, adverse effects, clinical questionnaire scores, Knee Society clinical scores, radiological rollback, radiolucencies, femorotibial angle and tibial slope) showed no statistically significant differences between the groups. In the subgroup analyses that allowed pooling of the results of the different studies, no homogeneous statistically significant differences were identified. Authors' conclusions The methodological quality and the quality of reporting of the studies were highly variable. With respect to range of motion, pain, clinical, and radiological outcomes, no clinically relevant differences were found between total knee arthroplasty with retention or sacrifice of the posterior cruciate ligament. Two statistically significant differences were found; range of motion was 2.4 degrees higher in the posterior cruciate ligament sacrificing group, however results were heterogeneous; and the mean functional Knee Society Score was 2.3 points higher in the posterior cruciate ligament sacrificing group. These differences are clinically not relevant

Effectiveness of interspinous implant surgery in patients with intermittent neurogenic claudication: a systematic review and meta-analysis

Item does not contain fulltextINTRODUCTION: Despite an increasing implantation rate of interspinous process distraction (IPD) devices in the treatment of intermittent neurogenic claudication (INC), definitive evidence on the clinical effectiveness of implants is lacking. The main objective of this review was to perform a meta-analysis of all systematic reviews, randomized clinical trials and prospective cohort series to quantify the effectiveness of IPDs and to evaluate the potential side-effects. METHODS: Data from all studies prospectively describing clinical results based on validated outcome scales and reporting complications of treatment of patients with INC with IPD placement. We searched MEDLINE, EMBASE, Web of Science, Cochrane (CENTRAL), CINAHL, Academic Search Premier, Science Direct up to July 2010. Studies describing patients with INC caused by lumbar stenosis, reporting complication rate and reporting based on validated outcome scores, were eligible. Studies with only instrumented IPD results were excluded. RESULTS: Eleven studies eligible studies were identified. Two independently RCTs and eight prospective cohorts were available. In total 563 patients were treated with IPDs. All studies showed improvement in validated outcome scores after 6 weeks and 1 year. Pooled data based on the Zurich Claudication Questionnaire of the RCTs were more in favor of IPD treatment compared with conservative treatment (pooled estimate 23.2, SD 18.5-27.8). Statistical heterogeneity after pooled data was low (I-squared 0.0, p = 0.930). Overall complication rate was 7%. CONCLUSION: As the evidence is relatively low and the costs are high, more thorough (cost-) effectiveness studies should be performed before worldwide implementation is introduced

Dexamethasone therapy versus surgery for chronic subdural haematoma (DECSA trial):study protocol for a randomised controlled trial

BACKGROUND: Chronic subdural haematoma (CSDH) is a common neurological disease with a rapidly rising incidence due to increasing age and widespread use of anticoagulants. Surgical intervention by burr-hole craniotomy (BHC) is the current standard practice for symptomatic patients, but associated with complications, a recurrence rate of up to 30% and increased mortality. Dexamethasone (DXM) therapy is, therefore, used as a non-surgical alternative but considered to achieve a lower success rate. Furthermore, the benefit of DXM therapy appears much more deliberate than the immediate relief from BHC. Lack of evidence and clinical equipoise among caregivers prompts the need for a head-to-head randomised controlled trial. The objective of this study is to compare the effect of primary DXM therapy versus primary BHC on functional outcome and cost-effectiveness in symptomatic patients with CSDH. METHODS/DESIGN: This study is a prospective, multicentre, randomised controlled trial (RCT). Consecutive patients with a CSDH with a Markwalder Grading Scale (MGS) grade 1 to 3 will be randomised to treatment with DXM or BHC. The DXM treatment scheme will be 16 mg DXM per day (8 mg twice daily, days 1 to 4) which is then halved every 3 days until a dosage of 0.5 mg a day on day 19 and stopped on day 20. If the treatment response is insufficient (i.e. persistent or progressive symptomatology due to insufficient haematoma resolution), additional surgery can be performed. The primary outcomes are the functional outcome by means of the modified Rankin Scale (mRS) score at 3 months and cost-effectiveness at 12 months. Secondary outcomes are quality of life at 3 and 12 months using the Short Form Health Survey (SF-36) and Quality of Life after Brain Injury Overall Scale (QOLIBRI), haematoma thickness after 2 weeks on follow-up computed tomography (CT), haematoma recurrence during the first 12 months, complications and drug-related adverse events, failure of therapy within 12 months after randomisation and requiring intervention, mortality during the first 3 and 12 months, duration of hospital stay and overall healthcare and productivity costs. To test non-inferiority of DXM therapy compared to BHC, 210 patients in each treatment arm are required (assumed adjusted common odds ratio DXM compared to BHC 1.15, limit for inferiority < 0.9). The aim is to include a total of 420 patients in 3 years with an enrolment rate of 60%. DISCUSSION: The present study should demonstrate whether treatment with DXM is as effective as BHC on functional outcome, at lower costs. TRIAL REGISTRATION: EUCTR 2015-001563-39 . Date of registration: 29 March 2015

Dexamethasone therapy versus surgery for chronic subdural haematoma (DECSA trial): study protocol for a randomised controlled trial

BACKGROUND: Chronic subdural haematoma (CSDH) is a common neurological disease with a rapidly rising incidence due to increasing age and widespread use of anticoagulants. Surgical intervention by burr-hole craniotomy (BHC) is the current standard practice for symptomatic patients, but associated with complications, a recurrence rate of up to 30% and increased mortality. Dexamethasone (DXM) therapy is, therefore, used as a non-surgical alternative but considered to achieve a lower success rate. Furthermore, the benefit of DXM therapy appears much more deliberate than the immediate relief from BHC. Lack of evidence and clinical equipoise among caregivers prompts the need for a head-to-head randomised controlled trial. The objective of this study is to compare the effect of primary DXM therapy versus primary BHC on functional outcome and cost-effectiveness in symptomatic patients with CSDH.METHODS/DESIGN: This study is a prospective, multicentre, randomised controlled trial (RCT). Consecutive patients with a CSDH with a Markwalder Grading Scale (MGS) grade 1 to 3 will be randomised to treatment with DXM or BHC. The DXM treatment scheme will be 16 mg DXM per day (8 mg twice daily, days 1 to 4) which is then halved every 3 days until a dosage of 0.5 mg a day on day 19 and stopped on day 20. If the treatment response is insufficient (i.e. persistent or progressive symptomatology due to insufficient haematoma resolution), additional surgery can be performed. The primary outcomes are the functional outcome by means of the modified Rankin Scale (mRS) score at 3 months and cost-effectiveness at 12 months. Secondary outcomes are quality of life at 3 and 12 months using the Short Form Health Survey (SF-36) and Quality of Life after Brain Injury Overall Scale (QOLIBRI), haematoma thickness after 2 weeks on follow-up computed tomography (CT), haematoma recurrence during the first 12 months, complications and drug-related adverse events, failure of therapy within 12 months after randomisation and requiring intervention, mortality during the first 3 and 12 months, duration of hospital stay and overall healthcare and productivity costs. To test non-inferiority of DXM therapy compared to BHC, 210 patients in each treatment arm are required (assumed adjusted common odds ratio DXM compared to BHC 1.15, limit for inferiority < 0.9). The aim is to include a total of 420 patients in 3 years with an enrolment rate of 60%.DISCUSSION: The present study should demonstrate whether treatment with DXM is as effective as BHC on functional outcome, at lower costs.TRIAL REGISTRATION: EUCTR 2015-001563-39 . Date of registration: 29 March 2015