Risk factors for neurophysiological events related to intraoperative halo-femoral traction in spinal deformity surgery.

PURPOSE: This study identifies risk factors for neurophysiological events caused by intraoperative halo-femoral traction (IOHFT) in patients with adolescent idiopathic scoliosis (AIS), and neuromuscular scoliosis (NMS). METHODS: Neurophysiological integrity was monitored using motor evoked potentials (MEPs). IONM event was defined as a decreased MEP amplitude of more than 80% of baseline in, at least, one muscle. Time between application of IOHFT and event, affected muscles, surgical stage, and time between removal of IOHFT and recovery of MEPs were described. Characteristics (age, height, weight, diagnosis, Cobb angle, and flexibility of the curve) of patients with and without IOHFT-events were compared using analysis of variance. Binary logistic regression analyses were performed to identify predictors. RESULTS: The study included 81 patients (age 15.6 ± 2.4 years, 53 females, AIS: n = 47, NMS n = 34). IOHFT-events occurred in 11 patients (13%; AIS n = 4, NMS n = 7). IOHFTevents affecting all limbs occurred pre-incision in NMS. Events affecting only the legs occurred during all stages of surgery. Patients with IOHFT-events were smaller (p = 0.009) and had stiffer curves (p = 0.046). Height was a predictor (odds ratio, 0.941; 95% confidence interval = 0.896-0.988). All MEPs recovered after removing IOHFT. CONCLUSION: Neurophysiologic events due to IOHFT were common, with the majority in patients with NMS. A shorter stature was a risk factor, and larger Cobb angle and stiffer curve were associated with IOHFT-events. Events occurred at any stage of surgery and involved upper and lower limbs. With an adequate response on IOHFT events, none of the patients had postoperative neurological impairments due to IOHFT.

Fracture rate after conventional external beam radiation therapy to the spine in multiple myeloma patients.

BACKGROUND CONTEXT: Conventional external beam radiation therapy (cEBRT) is used in multiple myeloma (MM) to treat severe pain, spinal cord compression, and disease-related bone disease. However, radiation may be associated with an increased risk of vertebral compression fractures (VCFs), which could substantially impair survival and quality of life. Additionally, the use of the Spinal Instability Neoplastic Score (SINS) in MM is debated in MM. PURPOSE: To determine the incidence of VCFs after cEBRT in patients with MM and to assess the applicability of the SINS score in the prediction of VCFs in MM. STUDY DESIGN: Retrospective multicenter cohort study. PATIENT SAMPLE: MM patients with spinal myeloma lesions who underwent cEBRT between January 2010 and December 2021. OUTCOME MEASURES: Frequency of new or progressed VCFs and subdistribution hazard ratios for potentially associated factors. METHODS: Patient and treatment characteristics were manually collected from the patients' electronic medical records. Computed tomography (CT) scans from before and up to 3 years after the start of radiation were used to score radiographic variables at baseline and at follow-up. Multivariable Fine and Gray competing risk analyses were performed to evaluate the diagnostic value of the SINS score to predict the postradiation VCF rate. RESULTS: A total of 127 patients with 427 eligible radiated vertebrae were included in this study. The mean age at radiation was 64 years, and 66.1% of them were male. At the start of radiation, 57 patients (44.9%) had at least one VCF. There were 89 preexisting VCFs (18.4% of 483 vertebrae). Overall, 39 of 127 patients (30.7%) reported new fractures (number of vertebrae (n)=12) or showed progression of existing fractures (n=36). This number represented 11.2% of all radiated vertebrae. Five of the 39 (12.8%) patients with new or worsened VCFs received an unplanned secondary treatment (augmentation [n=2] or open surgery [n=3]) within 3 years. Both the total SINS score (SHR 1.77; 95% confidence interval (CI) 1.54-2.03; p<.001) and categorical SINS score (SHR 10.83; 95% CI 4.20-27.94; p<.001) showed an independent association with higher rates of new or progressed VCFs in adjusted analyses. The use of bisphosphonates was independently associated with a lower rate of new or progressed VCFs (SHR 0.47 [95% CI 0.24-0.92; p=.027]). CONCLUSIONS: This study demonstrated that new or progressed VCFs occurred in 30.7% of patients within 3 years, in a total of 11.2% of vertebrae. The SINS score was found to be independently associated with the development or progression of VCFs and could thus be applied in MM for fracture prediction and possibly prevention.

Minimally Invasive Posterior Spinal Nonfusion Surgery in Patients With Adolescent Idiopathic Scoliosis Using a Bipolar One-Way Self-Expanding Rod System: Protocol for a Single-Center Clinical Cohort Study.

BACKGROUND: The current surgical treatment for patients diagnosed with progressive and severe adolescent idiopathic scoliosis (AIS) consists of the correction of the spinal curvature, followed by posterior spinal fusion (PSF). However, research has uncovered short- and long-term complications of posterior spinal fusion in patients with AIS. Minimally invasive growing rod techniques have successfully been used to treat patients with early-onset scoliosis and neuromuscular scoliosis. It may be questioned if minimally invasive posterior spinal nonfusion (PSnF) surgery with bipolar instrumentation can be used for the treatment of AIS. OBJECTIVE: This study will be performed to monitor the efficacy and safety of PSnF surgery by using a commercially available Conformité Européenne-certified spinal implant consisting of bilateral bipolar one-way self-expanding rods (OWSER) for the treatment of patients diagnosed with AIS. METHODS: In 14 selected patients with AIS with Lenke 1-6 curves, minimally invasive PSnF surgery with the OWSER system is performed after the failure of conservative treatment (curve progression of >5° within 1 year). The patients are over 7 years of age, with a major Cobb angle of ≥30°, sufficient flexibility, and a Risser stage of ≤2. Patients will be followed over time, according to the standard medical care. Efficacy will be measured using radiological and patient satisfaction assessments and safety will be determined by the amount of perioperative complications. RESULTS: Patient inclusion started on November 17, 2021 and we hope to finalize patient inclusion by the beginning of 2025. The first results will be expected by the beginning of 2024. CONCLUSIONS: Minimally invasive PSnF in patients with AIS is presented as a less invasive surgical technique that prevents the progression of the scoliotic curve and that allows minor posture correction of coronal imbalance. This will be the first study to examine whether the PSnF bipolar OWSER instrumentation will be the next generation of surgical instrumentation in AIS. TRIAL REGISTRATION: ClinicalTrials.gov NCT04441411; https://clinicaltrials.gov/study/NCT04441411. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47222.

High Failure Rates of a Unilateral Posterior Peri-Apical Distraction Device (ApiFix) for Fusionless Treatment of Adolescent Idiopathic Scoliosis.

BACKGROUND: Conventional surgical treatment for adolescent idiopathic scoliosis (AIS) consists of correction of the spinal deformity with rigid spinal instrumentation and fusion. Less-invasive and fusionless surgery could potentially improve patient outcomes. The purpose of the present study was to evaluate the efficacy of a recently U.S. Food and Drug Administration (FDA)-approved posterior peri-apical self-distracting device (ApiFix) that is designed to gradually correct the deformity without spinal fusion. METHODS: In a prospective cohort study of 20 patients with AIS (Risser stage 1-4; Lenke 1 or 5; major curve Cobb angle, 40° to 55°; and Bunnell scoliometer rotation, <15°) were managed with the ApiFix device. Clinical and radiographic performance was assessed. RESULTS: Twenty patients with a mean age (and standard deviation) of 14.8 ± 1.4 years were followed for a mean of 3.4 ± 1.0 years. The average major curve was reduced from 45.4° preoperatively to 31.4° at 2 weeks postoperatively and 31.0° at the time of the latest follow-up. The average minor curve measured 31.3° preoperatively, 26.1° at 2 weeks postoperatively, and 24.2° at the time of the latest follow-up. Ten patients had serious complications that required revision surgery, including osteolysis (n = 6), screw and/or rod breakage (n = 2), failure of the ratchet mechanism (n = 1), and pain without explainable cause (n = 1). During revision surgery, metallosis was observed in all patients and cultures showed growth of Cutibacterium acnes in 6 patients. Because of the high failure rate, the study was terminated early. CONCLUSIONS: The use of the unilateral peri-apical concave self-distracting ratchet rod initially was associated with promising clinical and radiographic results. However, no distraction was observed and the high rate of serious adverse events within 2 years was considered to be unacceptable for further clinical application of this device in our institution, despite recent FDA approval. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Comparing Ultrasound-Guided Needling Combined With a Subacromial Corticosteroid Injection Versus High-Energy Extracorporeal Shockwave Therapy for Calcific Tendinitis of the Rotator Cuff: A Randomized Controlled Trial.

PURPOSE: To compare clinical and radiographic outcomes after treatment with standardized high-energy extracorporeal shock wave therapy (ESWT) and ultrasound-guided needling (UGN) in patients with symptomatic calcific tendinitis of the rotator cuff who were nonresponsive to conservative treatment. METHODS: The study was designed as a randomized controlled trial. The ESWT group received ESWT (2000 pulses, energy flux density 0.35 mJ/mm2) in 4 sessions with 1-week intervals. UGN was combined with a corticosteroid ultrasound-guided subacromial bursa injection. Shoulder function was assessed at standardized follow-up intervals (6 weeks and 3, 6, and 12 months) using the Constant Murley Score (CMS), the Disabilities of the Arm, Shoulder, and Hand questionnaire, and visual analog scale for pain and satisfaction. The size, location, and morphology of the deposits were evaluated on radiographs. The a priori sample size calculation computed that 44 participants randomized in each treatment group was required to achieve a power of 80%. RESULTS: Eighty-two patients were treated (56 female, 65%; mean age 52.1 ± 9 years) with a mean baseline CMS of 66.8 ± 12 and mean calcification size of 15.1 ± 4.7 mm. One patient was lost to follow-up. At 1-year follow-up, the UGN group showed similar results as the ESWT group with regard to the change from baseline CMS (20.9 vs 15.7; P = .23), Disabilities of the Arm, Shoulder, and Hand questionnaire (-20.1 vs -20.7; P = .78), and visual analog scale for pain (-3.9 and -2.6; P = .12). The mean calcification size decreased by 13 ± 3.9 mm in the UGN group and 6.7 ± 8.2 mm in the ESWT group (

The biomechanical effect of single-level laminectomy and posterior instrumentation on spinal stability in degenerative lumbar scoliosis: a human cadaveric study.

OBJECTIVEDegenerative lumbar scoliosis, or de novo degenerative lumbar scoliosis, can result in spinal canal stenosis, which is often accompanied by disabling symptoms. When surgically treated, a single-level laminectomy is performed and short-segment posterior instrumentation is placed to restore stability. However, the effects of laminectomy on spinal stability and the necessity of placing posterior instrumentation are unknown. Therefore, the aim of this study was to assess the stability of lumbar spines with degenerative scoliosis, characterized by the range of motion (ROM) and neutral zone (NZ) stiffness, after laminectomy and placement of posterior instrumentation.METHODSTen lumbar cadaveric spines (T12-L5) with a Cobb angle ≥ 10° and an apex on L3 were included. Three loading cycles were applied per direction, from -4 Nm to 4 Nm in flexion/extension (FE), lateral bending (LB), and axial rotation (AR). Biomechanical evaluation was performed on the native spines and after subsequent L3 laminectomy and the placement of posterior L2-4 titanium rods and pedicle screws. Nonparametric and parametric tests were used to analyze the effects of laminectomy and posterior instrumentation on NZ stiffness and ROM, respectively, both on an individual segment's motion and on the entire spine section. Spearman's rank correlation coefficient was used to study the correlation between disc degeneration and spinal stability.RESULTSThe laminectomy increased ROM by 9.5% in FE (p = 0.04) and 4.6% in LB (p = 0.01). For NZ stiffness, the laminectomy produced no significant effects. Posterior instrumentation resulted in a decrease in ROM in all loading directions (-22.2%, -24.4%, and -17.6% for FE, LB, and AR, respectively; all p < 0.05) and an increase in NZ stiffness (+44.7%, +51.7%, and +35.2% for FE, LB, and AR, respectively; all p < 0.05). The same changes were seen in the individual segments around the apex, while the adjacent, untreated segments were mostly unaffected. Intervertebral disc degeneration was found to be positively correlated to decreased ROM and increased NZ stiffness.CONCLUSIONSLaminectomy in lumbar spines with degenerative scoliosis did not result in severe spinal instability, whereas posterior instrumentation resulted in a rigid construct. Also, prior to surgery, the spines already had lower ROM and higher NZ stiffness in comparison to values shown in earlier studies on nonscoliotic spines of the same age. Hence, the authors question the clinical need for posterior instrumentation to avoid instability.

Prediction of mechanical complications in adult spinal deformity surgery-the GAP score versus the Schwab classification.

BACKGROUND CONTEXT: Surgery for adult spinal deformity is a challenging and complex procedure with high reported complication (8.4%-42%) and revision rates (9%-17.6%). Failure to achieve or maintain adequate postoperative sagittal alignment has been reported to be the main cause of mechanical complications. In order to define appropriate surgical targets, the Scoliosis Research Society-Schwab classification and the Global Alignment and Proportion (GAP) score were established. In the literature, no study has yet compared these classification systems with respect to the risk of developing mechanical complications. PURPOSE: To assess and compare the ability of the Schwab classification and the GAP score to predict mechanical complications following adult spinal deformity surgery. STUDY DESIGN: Two-center, retrospective cohort study. PATIENT SAMPLE: Thirty-nine patients suffering adult spinal deformity who underwent long segment spinal fusion (≥4 levels), minimum follow-up of 2years. OUTCOME MEASURES: The ability of the Schwab classification and GAP score to predict mechanical failure was determined by computing the Area Under the receiver operating characteristic curve. METHODS: Full-spine pre- and postoperative radiographs of all patients were analyzed for mechanical complications. Subsequently, the pre- and postoperative Schwab and GAP score were determined. Logistic regression analysis was used to assess the ability of both systems to determine which was the most appropriate for the prediction of mechanical failure. Correlations between the various factors constituting the GAP score and Schwab classification were estimated using the Spearman rank order correlation coefficient. RESULTS: The results demonstrated that both classification systems are capable of predicting radiographic evidence of mechanical failure; however, the GAP score proved to be significantly better (p=.003). The relative pelvic version of the GAP score serves a similar role as the pelvic tilt modifier from the Schwab classification (ρ=-0.84, p<.01). The relative lumbar lordosis from the GAP score functions much like the PI-LL modifier from the Schwab classification (ρ=-0.94, p<.01). The GAP score is most significantly dependent on relative spinopelvic alignment, relative lumbar lordosis, and relative pelvic version (ρ=0.85, ρ=0.84, and ρ=0.84, respectively, p<.01). Correlation with the lordosis distribution index was also significant but was not as strong (ρ=0.65, p<.01). Age, on the contrary, showed poor correlation with the GAP score (ρ=0.17, p=.300). CONCLUSIONS: Both the Schwab classification and the GAP score are capable of predicting mechanical complications. The GAP score proved to be significantly more appropriate. This difference is probably attributed to the fact that in the GAP score all parameters are related to the patient's individual pelvic incidence.

Functional outcome of non-surgical and surgical management for de novo degenerative lumbar scoliosis: a mean follow-up of 10 years.

BACKGROUND: No studies have evaluated the long-term results of non-surgical and surgical management in de novo degenerative lumbar scoliosis (DNDLS). This study reports on the long-term functional outcome of patients being treated for DNDLS by non-surgical and surgical management. METHODS: This is a retrospective review of a single center database of DNDLS patients that underwent surgical or usual non-surgical management between 1996 and 2007. In a total of 88 patients, 50 (57%) underwent non-surgical and 38 (43%) surgical management. Baseline demographic, radiological-, clinical-, and surgical-related variables were collected. An Oswestry Disability Index (ODI) 2.0 questionnaire was sent to all patients after written informed consent. RESULTS: Twenty-nine of 88 patients participated in the study, 15 (52%) had undergone surgical and 14 (48%) non-surgical management with a mean follow-up of 10.9 years (range 8-15 years). There were no significant differences (p > 0.05) between non-surgical and surgical patients at baseline for age, body mass index, coronal Cobb angle, and clinical data. None of the non-surgical patients had undergone surgery during follow-up. In the surgical group, 40% had revision surgery. There was no significant difference in ODI total scores between groups at final follow-up (p = 0.649). A larger proportion of patients in the non-surgical group reported an ODI total score of ≤ 22, reflecting minimal disability (43 versus 20%; p = 0.245). CONCLUSIONS: This is the first study that describes the long-term 10-year functional outcome of non-surgical and surgical management in a cohort of patients with DNDLS. No significant difference in functional outcome was found between groups after a mean follow-up of 10 years. Despite the significant potential for selection bias, these results indicate that non-surgical management of patients with DNDLS may lead to adequate functional outcome after long periods of time, with no crossover to surgery. Further study is warranted to define which patients may benefit most from which management regimen.

Postoperative continuous-flow cryocompression therapy in the acute recovery phase of hip fracture surgery-A randomized controlled clinical trial.

BACKGROUND: The acute recovery phase after hip fracture surgery is often complicated by severe pain, postoperative blood loss with subsequent transfusion, and delirium. Prevalent comorbidity in hip fracture patients limit the use of opioid-based analgesic therapies, yielding a high risk for inferior pain treatment. Postoperative cryotherapy is suggested to provide an analgesic effect, and to reduce postoperative blood loss. In this prospective, open-label, parallel, multicentre, randomized controlled, clinical trial, we aimed to determine the efficacy of continuous-flow cryocompression therapy (CFCT) in the acute recovery phase after hip fracture surgery. METHODS: Patients with an intra or extracapsular hip fracture scheduled for surgery were included. Subjects were allocated to receive postoperative CFCT or usual care. The primary endpoint was numeric rating scale (NRS) pain the first 72 postoperative hours. Secondly, analgesic use; postoperative haemoglobin change and transfusion incidence; functional outcome; length of stay; delirium incidence; location of rehabilitation; patient-reported health outcome; complications and feasibility were assessed. RESULTS: Sixty-one subjects in the control group, and 64 subjects in the CFCT group were analysed. Within the CFCT group, post treatment NRS pain declined 0.31 (p=0.07) at 24h, 0.28 (p=0.07) at 48h, and 0.47 (p=0.002) at 72h relative to pre treatment NRS pain. Sensitivity analysis at 72h showed that NRS pain was 0.92 lower in the CFCT group when compared to the control group (1.50 vs. 2.42; p=0.03). Postoperative analgesic use was comparable between groups. Between postoperative day one and three haemoglobin declined 0.29mmol/l in the CFCT group and 0.51mmol/l in controls (p=0.06), and transfusion incidence was comparable. The timed up and go test and length of stay were also comparable between both groups. Complications, amongst delirium and cryotherapy-related adverse events were not statistically significantly different. Discharge locations did not differ between groups. At outpatient follow-up subjects did not differ in patient-reported health outcome scores. Subjects rated CFCT satisfaction with an average of 7.1 out of 10 points. CONCLUSIONS: No evidence was recorded to suggest that CFCT has an added value in the acute recovery phase after hip fracture surgery. If patients complete the CFCT treatment schedule, a mild analgesic effect is observed at 72h.

A Novel Spinal Implant for Fusionless Scoliosis Correction: A Biomechanical Analysis of the Motion Preserving Properties of a Posterior Periapical Concave Distraction Device.

STUDY DESIGN: Biomechanical study. OBJECTIVE: Recently, a posterior concave periapical distraction device for fusionless scoliosis correction was introduced. The goal of this study was to quantify the effect of the periapical distraction device on spinal range of motion (ROM) in comparison with traditional rigid pedicle screw-rod instrumentation. METHODS: Using a spinal motion simulator, 6 human spines were loaded with 4 N m and 6 porcine spines with 2 N m to induce flexion-extension (FE), lateral bending (LB), and axial rotation (AR). ROM was measured in 3 conditions: untreated, periapical distraction device, and rigid pedicle screw-rod instrumentation. RESULTS: The periapical distraction device caused a significant (P < .05) decrease in ROM of FE (human, -40.0% and porcine, -55.9%) and LB (human, -18.2% and porcine, -17.9%) as compared to the untreated spine, while ROM of AR remained unaffected. In comparison, rigid instrumentation caused a significantly (P < .05) larger decrease in ROM of FE (human, -80.9% and porcine, -94.0%), LB (human, -75.0% and porcine, -92.2%), and AR (human, -71.3% and porcine, -86.9%). CONCLUSIONS: Although no destructive forces were applied, no device failures were observed. Spinal ROM was significantly less constrained by the periapical distraction device compared to rigid pedicle screw-rod instrumentation. Therefore, provided that scoliosis correction is achieved, a more physiological spinal motion is expected after scoliosis correction with the posterior concave periapical distraction device.

Patient sexual function and hip replacement surgery: A survey of surgeon attitudes.

PURPOSE: To explore practises of orthopaedic surgeons (and residents) in addressing sexual function (SF) in patients before and after total hip arthroplasty (THA). METHODS: A 26-item questionnaire was sent to health professionals (n = 849); 526 (62.0%) responses were included in the analyses. RESULTS: About 78% of the respondents (77.5%) almost never addressed SF. The most mentioned reason was that "patients do not ask" (47.4%) followed by "I am not aware of possible needs" (38.6%). SF was even less discussed (25.9%) in elderly patients (>60 years). The beneficial effect of THA on SF was rated the highest in retired surgeons (p ≤ 0.001), in which male surgeons scored higher than female surgeons (p = 0.002). The importance of sexual dificulties (SD) in the decision to undergo surgery was rated lowest by residents (p = 0.020). Rating the risk for dislocation varied between occupations (p = 0.008) and gender (p = 0.016), female surgeons rated highest (median 5); 54.1% indicated the orthopaedic surgeon is responsible for providing information about the safe resumption of sexual activity. CONCLUSIONS: Surgeons show little attention to SF related issues in THA patients, which seems not in accordance to patients' needs. Addressing SF increases throughout a surgeon's career. There were divergent views and there is no "common advice" about the safe resumption of sexual activity. The results emphasize the need for guidelines and training in order to encourage addressing SF both, before and after THA.

Does total hip replacement affect sexual quality of life?

BACKGROUND: Total Hip Replacement (THR) is an effective treatment for end-stage hip osteoarthritis. Since the introduction of total joint replacement, the effect on the Sexual Quality of Life (SQoL) following THR has been addressed in scant studies. The aim of our study was to systematically review the literature, to summarise effects of THR on patients' SQoL. METHODS: We searched PubMed, EMBASE and PsycINFO between January 1970 and February 9th, 2015 with search terms including Total Hip, Osteoarthritis, SQoL, and THR. Eligible studies were identified and two independent authors extracted data including details of SQoL, study quality and risk of bias. RESULTS: There were 12 eligible studies, which included a total of 2099 patients with an age range of 20-85 years. The methodological quality of ten studies was rated as low, and of two as moderate. Amongst the majority of patients, SQoL improved after surgery, both in terms of physical-functional and psychosocial well-being. However, changes between pre-operative and postoperative SQoL ranged extensively: for example, Sexual Dysfunction Δ 8-51% and Sexual Activity (SA) Δ 0-77%. Three studies reported that some patients never resumed SA again after surgery. CONCLUSION: In over 40 years of THR treatment, scant studies have examined the effect of THR on patients' SQoL. This review suggests that SQol improves after THR, although the magnitude of effects varies highly. However, the quality of the supporting evidence was rated as low to moderate. This suggests a need for more high quality evidence about the effects of THR on SQoL.

The efficacy of continuous-flow cryo and cyclic compression therapy after hip fracture surgery on postoperative pain: design of a prospective, open-label, parallel, multicenter, randomized controlled, clinical trial.

BACKGROUND: The number of hip fractures and resulting post-surgical outcome are a major public health concern and the incidence is expected to increase significantly. The acute recovery phase after hip fracture surgery in elder patients is often complicated by severe pain, high morphine consumption, perioperative blood loss with subsequent transfusion and delirium. Postoperative continuous-flow cryocompression therapy is suggested to minimize these complications and to attenuate the inflammatory reaction that the traumatic fracture and subsequent surgical trauma encompass. Based on a pilot study in patients undergoing total hip arthroplasty for osteoarthritis, it is anticipated that patients treated with continuous-flow cryocompression therapy will have less pain, less morphine consumption and lower decrease of postoperative hemoglobin levels. These factors are associated with a shorter hospital stay and better long-term (functional) outcome. METHODS/DESIGN: One hundred and sixty patients with an intra or extracapsular hip fracture scheduled for internal fixation (intramedullary hip nail, dynamic hip screw or cannulated screws) or prosthesis surgery (total hip or hemiarthroplasty) will be included in this prospective, open-label, parallel, multicenter, randomized controlled, clinical superiority trial. Patients will be allocated to two treatment arms: group 'A' will be treated with continuous-flow cryocompression therapy and compared to group 'B' that will receive standard care. Routine use of drains and/or compressive bandages is allowed in both groups. The primary objective of this study is to compare acute pain the first 72 h postoperative, measured with numeric rating scale for pain. Secondary objectives are: (non-) morphine analgesic use; adjusted postoperative hemoglobin level; transfusion incidence; incidence, duration and severity of delirium and use of psychotropic medication; length of stay; location and duration of rehabilitation; functional outcome; short-term patient-reported health outcome; general and cryotherapy related complications and feasibility. DISCUSSION: This is the first randomized controlled trial that will assess the analgesic efficiacy of continuous-flow cryocompression therapy in the acute recovery phase after hip fracture surgery. TRIAL REGISTRATION: www.trialregister.nl, NTR4152 (23(rd) of August 2013).

High correlation of the Oxford Knee Score with postoperative pain, but not with performance-based functioning.

PURPOSE: The Oxford Knee Score (OKS) is a widely known patient-related outcome measure (PROM) to determine pain and knee functioning before and after total knee arthroplasty (TKA). Self-reported function is mainly influenced by change in pain; therefore, it was hypothesized that the OKS correlates more with pain than with performance-based functioning. METHODS: In a prospective cohort of 88 patients, who had a cementless mobile-bearing TKA, included in a randomized clinical trial, the correlation between the overall OKS, and its subscales for pain (PCS) and function (FCS), with performance-based functioning using the DynaPort® Knee Score (DKS), visual analogue scale score for pain (VAS) and the Knee Society Score (KSS) was evaluated. All scores were measured preoperatively, 6 months and 1 year after surgery. Overall change in outcome over time was analysed until 5 years after surgery. RESULTS: All scores improved over time. The DKS was influenced by sex, preoperative BMI and age. The internal consistency of the OKS PCS increased over time, whereas the OKS FCS remained the same. The mean postoperative OKS FCS showed moderate correlation with the DKS (r = 0.65, p < 0.001), and the mean postoperative OKS and OKS PCS showed high correlation with the VAS (r = -0.79 and r = -0.82, respectively, p < 0.001). The mean postoperative KSS showed high correlations with the OKS (r = 0.80, p < 0.001), the OKS PCS (r = 0.72 p < 0.001) and OKS FCS (r = 0.74, p < 0.001). CONCLUSION: The postoperative OKS and the OKS PCS showed high correlation with pain, but only the postoperative OKS FCS was well correlated with performance-based functioning. This suggests that the OKS is more related to pain and tells us less on postoperative functioning. This is important when the OKS as PROM is used to evaluate the quality of orthopaedic care of patients with TKA. LEVEL OF EVIDENCE: III.

How Does Spinal Release and Ponte Osteotomy Improve Spinal Flexibility? The Law of Diminishing Returns.

STUDY DESIGN: Experimental study. OBJECTIVES: To evaluate the effect of stepwise resection of posterior spinal ligaments, facet joints, and ribs on thoracic spinal flexibility. SUMMARY OF BACKGROUND DATA: Posterior spinal ligaments, facet joints and ribs are removed to increase spinal flexibility in corrective spinal surgery for deformities such as adolescent idiopathic scoliosis (AIS). Reported clinical results vary and biomechanical substantiation is lacking. METHODS: Ten fresh-frozen human cadaveric thoracic spinal specimens (T6-T11) were studied. A spinal motion simulator applied a pure moment of ±2.5 Nm in flexion, extension, lateral bending (LB) and axial rotation (AR). Range of motion (ROM) was measured for the intact spine and measured again after stepwise resection of the supra/interspinous ligament (SIL), inferior facet, flaval ligament, superior facet, and rib heads. RESULTS: SIL resection increased ROM in flexion (10.2%) and AR (3.1%). Successive inferior facetectomy increased ROM in flexion (4.1%), LB (3.8%) and AR (7.7%), and flavectomy in flexion (9.1%) and AR (2.5%). Sequential superior facetectomy only increased ROM in flexion (6.3%). Rib removal provided an additional increase in flexion (6.3%), LB (4.5%) and AR (13.0%). Extension ROM increased by 10.5% after the combined removal of the SIL, inferior facet and flaval ligament. CONCLUSIONS: Posterior spinal releases in these non-scoliotic spines led to an incremental increase in spinal flexibility, but each sequential step had less effect. As compared to SIL resection with inferior facetectomy, additional superior facetectomy did not improve flexibility in AR and LB and only 6.3% in flexion. The data presented from this in vitro study should be interpreted with care, as no representative cadaveric spine model for AIS was available, However, the results presented here at least question the benefits of performing routine complete facetectomies (i.e. Ponte osteotomies) to increase spinal flexibility in scoliosis surgery.

Spinal fusion using adipose stem cells seeded on a radiolucent cage filler: a feasibility study of a single surgical procedure in goats.

PURPOSE: To assess the feasibility of a one-step surgical concept, employing adipose stem cells (ASCs) and a novel degradable radiolucent cage filler (poly-L-lactide-co-caprolactone; PLCL), within polyetheretherketone cages in a stand-alone caprine spinal fusion model. METHODS: A double-level fusion study was performed in 36 goats. Four cage filler groups were defined: (i) acellular PLCL, (ii) PLCL + SVF (freshly harvested stromal vascular fraction highly enriched in ASCs); (iii) PLCL + ASCs (cultured to homogeneity); and (iv) autologous iliac crest bone graft (ABG). Fusion was assessed after 3 and 6 months by radiography, micro-CT, biomechanics, and biochemical analysis of tissue formed inside the cage after 6 months. RESULTS: No adverse effects were observed in all groups. After 3 months, similar and low fusion rates were found. Segmental stability did not differ between groups in all tested directions. Micro-CT imaging revealed significantly higher amounts of mineralized tissue in the ABG group compared to all others. After 6 months, interbody fusion rates were: PLCL 53%, SVF 30%, ASC 43% and ABG 63%. A trend towards higher mineralized tissue content was found for the ABG group. Biochemical and biomechanical analyses revealed equal maturity of collagen cross-links and similar segmental stability between all groups. CONCLUSIONS: This study demonstrates the technical feasibility and safety of the one-step surgical procedure for spinal fusion for the first time. The radiolucent PLCL scaffold allowed in vivo monitoring of bone formation using plain radiography. Addition of stem cells to the PLCL scaffolds did not result in adverse effects, but did not enhance the rate and number of interbody fusions under the current conditions. A trend towards superior results with ABG was found. Further research is warranted to optimize the spinal fusion model for proper evaluation of both PLCL and stem cell therapy.

No clinical benefit of titanium nitride coating in cementless mobile-bearing total knee arthroplasty.

PURPOSE: Titanium nitride (TiN) coating of cobalt-chromium-molybdenum (CoCrMo) implants has shown to improve the biomechanical properties of the implant surface and to reduce adhesive wear in vitro. It is yet unknown whether TiN coating of total knee prosthesis (TKP) affects the postoperative clinical outcome of total knee arthroplasty (TKA). METHODS: In a double-blind randomized controlled clinical trial, 101 patients received an uncemented mobile-bearing CoCrMo TKP, either TiN coated or uncoated. Primary outcome measure visual analogue scale (VAS) score for pain, and secondary outcome measures Knee Society Score (KSS), revision rate and adverse events, range of motion of the knee as well as knee circumference and knee skin temperature were assessed 6 weeks, 6 months, 1 year and 5 years postoperative. Repeated measures analysis was used to evaluate the postoperative outcome measures over time. RESULTS: There was no difference between the two groups in VAS score, KSS, revision rate, range of motion of the knee, knee circumference and knee skin temperature. There were no adverse events that could be related to the TiN coating. CONCLUSIONS: TiN-coated TKP does not influence the postoperative outcome of uncemented mobile-bearing TKA regarding postoperative pain, revision rate, range of motion, swelling and temperature of the knee. Therefore, TiN coating of CoCrMo TKP has no clinical benefit on the outcome of cementless mobile-bearing TKA. LEVEL OF EVIDENCE: Therapeutic study, Level I.

Targeting JNK-interacting-protein-1 (JIP1) sensitises osteosarcoma to doxorubicin.

Osteosarcoma (OS) is the most common primary malignant bone tumour in children and adolescents. Despite aggressive therapy, survival outcomes remain unsatisfactory, especially for patients with metastatic disease or patients with a poor chemotherapy response. Chemoresistance contributes to treatment failure. To increase the efficacy of conventional chemotherapy, essential survival pathways should be targeted concomitantly. Here, we performed a loss-of-function siRNA screen of the human kinome in SaOS-2 cells to identify critical survival kinases after doxorubicin treatment. Gene silencing of JNK-interacting-protein-1 (JIP1) elicited the most potent sensitisation to doxorubicin. This candidate was further explored as potential target for chemosensitisation in OS. A panel of OS cell lines and human primary osteoblasts was examined for sensitisation to doxorubicin using small molecule JIP1-inhibitor BI-78D3. JIP1 expression and JIP1-inhibitor effects on JNK-signalling were investigated by Western blot analysis. JIP1 expression in human OS tumours was assessed by immunohistochemistry on tissue micro arrays. BI-78D3 blocked JNK-signalling and sensitised three out of four tested OS cell lines, but not healthy osteoblasts, to treatment with doxorubicin. Combination treatment increased the induction of apoptosis. JIP1 was found to be expressed in two-thirds of human primary OS tissue samples. Patients with JIP1 positive tumours showed a trend to inferior overall survival. Collectively, JIP1 appears a clinically relevant novel target in OS to enhance the efficacy of doxorubicin treatment by means of RNA interference or pharmacological inhibition.

Treatment of severe osteochondral defects of the knee by combined autologous bone grafting and autologous chondrocyte implantation using fibrin gel.

PURPOSE: Severe symptomatic and unstable osteochondral defects of the knee are difficult to treat. A variety of surgical techniques have been developed. However, the optimal surgical technique is still controversial. We present a novel technique in which autologous bone grafting is combined with gel-type autologous chondrocyte implantation (GACI). METHODS: Isolated severe osteochondral defects of the medial or lateral femoral condyle were treated by a two-step procedure. Firstly, chondrocytes were harvested during arthroscopy and cultured for 6 weeks. Secondly, a full thickness corticospongious autologuos bone graft, harvested from the medial or lateral femur condyle, is impacted in the defect and covered by GACI. The fibrin gel fills up to the exact shape of the chondral lesion and polymerizes within 3 min after application. RESULTS: From 2009 to 2011, 9 patients, median age 35 years (range 23­47), were treated by the combined autologous bone grafting and GACI technique. Median defect size was 7.1 cm2 (range 2.5­12.0), and median depth of the lesion was 0.9 cm (range 0.8­1.2). Median follow-up was 9 months (range 6­12 months). Six patients were available for 12-month follow-up. The mean IKDC score showed a 6-month improvement from 35 (SD ± 16) to 51 (SD ± 18) (n = 9; p = 0.01), and a 1-year improvement from 35 (SD ± 16) to 57 (SD ± 20) (n = 6; p = 0.03). The mean KOOS improved from 44 (SD ± 16) to 62 (SD ± 19) (n = 9; p = 0.07) at 6-month follow-up and from 44 (SD ± 16) to 65 (SD ± 24) (n = 6; p = 0.1) at 12-month follow-up. There was one failure that needed conversion to a unicompartmental knee arthroplasty. CONCLUSION: Combined autologous bone grafting and GACI may offer an alternative surgical option for severe and unstable osteochondral defects of the knee.