scholarly journals Multi-layer cell-free scaffolds for osteochondral defects of the knee: a systematic review and meta-analysis of clinical evidence

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Angelo Boffa ◽  
Luca Solaro ◽  
Alberto Poggi ◽  
Luca Andriolo ◽  
Davide Reale ◽  
...  

Abstract Purpose The aim of this study was to analyze the clinical results provided by multi-layer cell-free scaffolds for the treatment of knee osteochondral defects. Methods A systematic review was performed on PubMed, Web of Science, and Cochrane to identify studies evaluating the clinical efficacy of cell-free osteochondral scaffolds for knee lesions. A meta-analysis was performed on articles reporting results of the International Knee Documentation Committee (IKDC) and Tegner scores. The scores were analyzed as improvement from baseline to 1, 2, and ≥ 3 years of follow-up. The modified Coleman Methodology Score was used to assess the study methodology. Results A total of 34 studies (1022 patients) with a mean follow-up of 35 months was included. Only three osteochondral scaffolds have been investigated in clinical trials: while TruFit® has been withdrawn from the market for the questionable results, the analysis of MaioRegen and Agili-C™ provided clinical improvements at 1, 2, and ≥ 3 years of follow-up (all significantly higher than the baseline, p < 0.05), although with a limited recovery of the sport-activity level. A low rate of adverse events and an overall failure rate of 7.0% were observed, but the overall evidence level of the available studies is limited. Conclusions Multi-layer scaffolds may provide clinical benefits for the treatment of knee osteochondral lesions at short- and mid-term follow-up and with a low number of failures, although the sport-activity level obtained seems to be limited. Further research with high-level studies is needed to confirm the role of multi-layer scaffold for the treatment of knee osteochondral lesions.

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Martina Ricci ◽  
Daniele Tradati ◽  
Alessio Maione ◽  
Francesco Mattia Uboldi ◽  
Eva Usellini ◽  
...  

Abstract Purpose The treatment of osteochondral lesions is challenging and no consensus has been established about the best option for restoring both cartilage and subchondral bone. Multilayer collagen-hydroxyapatite scaffolds have shown promising clinical results, but the outcome at a follow-up longer than 5 years still has to be proved. The aim was to evaluate the clinical outcome of patients with a knee isolated osteochondral lesion treated with a biomimetic three-layered scaffold at a minimum 5 years of follow-up. Methods Twenty-nine patients (23 males and 6 females, mean age 31.5 ± 11.4 years) were evaluated retrospectively before surgery, at 1 and 2 years and at last follow-up (FU). Visual Analog Scale (VAS) for pain, International Knee Documentation Committee (IKDC) Subjective Score, Tegner-Lysholm Knee Scoring Scale and Tegner Activity Level Scale were collected. Mean FU was 7.8 ± 2.0 years (min 5.1 - max 11.3). The etiology of the defect was Osteochondritis Dissecans or osteonecrosis (17 vs 12 cases). Results At 12 months FU the IKDC score improved from 51.1 ± 21.7 to 80.1 ± 17.9 (p < 0.01), Tegner Lysholm Score from 59.9 ± 17.3 to 92.5 ± 9.0 (p < 0.01), VAS from 6.1 ± 2.1 to 1.7 ± 2.3 (p < 0.01) and Tegner Activity Level Scale from 1.6 ± 0.5 to 4.9 ± 1.7 (p < 0.01). The results remained stable at 24 months, while at last FU a statistically significant decrease in IKDC, Tegner Lysholm and Tegner Activity Scale was recorded, though not clinically relevant. Patients under 35 achieved statistically better outcomes. Conclusions The use of a cell-free collagen-hydroxyapatite osteochondral scaffold provides substantial clinical benefits in the treatment of knee osteochondral lesions at a minimum follow-up of 5 years, especially in patients younger than 35 years. Level of evidence Level IV.


Cartilage ◽  
2019 ◽  
pp. 194760351987084 ◽  
Author(s):  
Matthias R. Steinwachs ◽  
Justus Gille ◽  
Martin Volz ◽  
Sven Anders ◽  
Roland Jakob ◽  
...  

Objective A systematic review and meta-analysis of Autologous Matrix-Induced Chondrogenesis (AMIC®) outcomes for grade III/IV chondral and osteochondral lesions of the knee treated with Chondro-Gide®. Design Studies with a minimum follow-up of 1 year providing clinical results of AMIC repair in the knee were included based on PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Methodological quality was assessed by the modified Coleman Methodology Score (mCMS). The meta-analysis was comparing pain VAS (Visual Analog Scale), Lysholm score, and IKDC score (International Knee Documentation Committee) between baseline and follow-up after 1 or 2 years and after >3 years. Results Twelve studies (375 patients) were included. The mCMS demonstrated a suboptimal study design (ranking between 52 and 80). The mean age was 36.2 years (14-70 years). The mean defect size was 4.24 cm2 (0.8-22 cm2). The results from the random effects model indicated a clinically significant ( P < 0.05) improvement of pain VAS from baseline to follow-up at year 1 to 2 of −4.02(confidence interval −4.37; −3.67), still significant after 3 years. Lysholm score at year 1 or 2 improved significantly and remained highly significant after 3 years. IKDC score showed highly significant improvement of 32.61 between 1 and 2 years versus baseline values maintained after 3 years. Conclusions The AMIC procedure significantly improved the clinical status and functional scoring versus preoperative values. Evidence was obtained in a non-selected patient population, corresponding to real-life treatment of knee chondral and osteochondral defects. The evidence is sufficient to recommend AMIC in this indication.


2019 ◽  
Vol 8 (11) ◽  
pp. 1978 ◽  
Author(s):  
Andrea Sessa ◽  
Luca Andriolo ◽  
Alessandro Di Martino ◽  
Iacopo Romandini ◽  
Roberto De Filippis ◽  
...  

The purpose of this study was to investigate the clinical results at five years’ follow-up of a tri-layered nanostructured biomimetic osteochondral scaffold used for focal articular cartilage defects in patients meeting the criteria of early osteoarthritis (EOA). The study population comprised 22 patients (mean age: 39 years), prospectively assessed before surgery, at 24 and 60 months’ follow-up. Inclusion criteria were: at least two episodes of knee pain for more than 10 days in the last year, Kellgren-Lawrence OA grade 0, I or II and arthroscopic or MRI findings according to the European Society of Sports Traumatology, Knee Surgery & Arthroscopy (ESSKA) criteria. Clinical results demonstrated significant improvement in International Knee Documentation Committee (IKDC) subjective and objective scores and in Tegner score, although activity level never reached the pre-injury level. The complication rate of this study was 8.3%. Two patients underwent re-operation (8.3%), while a comprehensive definition of failure (including both surgical and clinical criteria) identified four failed patients (16.6%) at this mid-term follow-up evaluation. The use of a free-cell osteochondral scaffold represented a safe and valid alternative for the treatment of focal articular cartilage defects in the setting of an EOA, and was able to permit a significant clinical improvement and stable outcome with low complication and failure rates.


Author(s):  
Pengfei Zhao ◽  
Qian Wang ◽  
Peng Zhang ◽  
Xinyi Zhou ◽  
Lulingxiao Nie ◽  
...  

The aim of this systematic review and meta-analysis was to determine the efficacy of chlorhexidine (CHX) as an adjunctive therapy to mechanical debridement in the treatment of peri-implant diseases. Five databases (PubMed, EMBASE, Cochrane Central Register of Controlled Trails, Web of Science, and ClinicalTrials.gov) were searched. Randomized controlled trials (RCTs) comparing mechanical debridement combined with CHX to mechanical debridement alone for patients with peri-implant disease were identified. The trial investigators evaluated factors indicating inflammatory levels, including bleeding on probing (BOP), probing depth (PD), and clinical attachment level (CAL). Six RCTs with 207 patients were ultimately included in this review. Low- to moderate-quality evidence demonstrated that the adjunctive CHX therapy had no significant effect on BOP reduction within 1 month (mean difference [MD], 0.10; 95% confidence interval [CI], -0.06 to 0.25), 3 to 4 months (MD, 0.06; 95% CI, -0.03 to 0.15), and 6 to 8 months (MD, 0.06; 95% CI, -0.03 to 0.14) follow-up. Significant differences in PD reduction and CAL gain were also not found. However, one subgroup analysis revealed a significant result for the use of CHX solution, but it was clinically slight (MD, 0.09; 95%CI, 0.01 to 0.18). Based on available evidence, adding CHX to mechanical debridement, compared to mechanical debridement alone, did not significantly enhance the clinical results. Therefore, clinicians should consider the negligible effect of adjunctive CHX.


2019 ◽  
Vol 11 (2) ◽  
pp. 123-133 ◽  
Author(s):  
Alberto Grassi ◽  
James R. Bailey ◽  
Giuseppe Filardo ◽  
Kristian Samuelsson ◽  
Stefano Zaffagnini ◽  
...  

Context: Meniscal injuries are common among both sport- and non–sport-related injuries, with over 1.7 million meniscal surgeries performed worldwide every year. As meniscal surgeries become more common, so does meniscal allograft transplantation (MAT). However, little is known about the outcomes of MAT in active patients who desire to go back to preinjury activities. Objective: The purpose of this systematic review and meta-analysis was to evaluate return to sport, clinical outcome, and complications after MAT in sport-active patients. Data Sources: A systematic search of MEDLINE, EMBASE, and CINAHL electronic databases was performed on February 25, 2018. Study Selection: Studies of level 1 through 4 evidence looking at MAT in physically active patients with reported return to activity outcomes and at least 2-year follow-up were included. Study Design: Systematic review and meta-analysis. Level of Evidence: Level 4. Data Extraction: Details of sport-related outcomes and reoperations were extracted and pooled in a meta-analysis. Results: Nine studies were included in this systematic review. A majority (77%) of athletes and physically active patients were able to return to sport after MAT; two-thirds were able to perform at preinjury levels. Graft-related reoperations were reported in 13% of patients, while the joint replacement rate with partial or total knee prosthesis was 1.2%. Conclusion: Physical activity after MAT appears possible, especially for low-impact sports. However, because of the limited number of studies, their low quality, and the short-term follow-up, the participation recommendation for high-impact and strenuous activities should be considered with caution until high-quality evidence of long-term safety becomes available.


2018 ◽  
Vol 31 (10) ◽  
pp. 999-1006 ◽  
Author(s):  
Juned Ansari ◽  
Hemant Pandit ◽  
Tsuneari Takahashi

AbstractKinematically aligned total knee arthroplasty (KATKA) was developed to more anatomically align the knee prosthesis to restore the native alignment of the knee and promote physiological kinematics. Even though there are concerns with implant survival, and follow-up at 10 years or more after KATKA has not been reported, there is a negligible incidence of failure of a tibial component at 2 to 9 years. Early clinical results with this technique are encouraging and demonstrate better functional outcomes compared with mechanically aligned TKA (MATKA). The purpose of this study is to perform a systematic review and meta-analysis of the literature to determine whether there are any clinical differences between KATKA and MATKA. The authors conducted a systematic review of the English literature. Five randomized controlled trials (RCTs) which compared clinical outcomes of KATKA and MATKA were finally included. Four RCTs used patient-specific instrument, and one RCT used navigation. Data were extracted and meta-analysis was conducted. KATKA patients had better outcomes: Mean difference between KATKA and MATKA and p-value are presented in brackets after each variable: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (–12.5; p < 0.0001), Oxford Knee Score (OKS) (2.3; p = 0.030), combined Knee Society Score (C-KSS) (13.1; p < 0.0001), Knee Function Score (KFS) (6.4; p = 0.0070), and postoperative range of motion (ROM) (4.1°; p = 0.0010). There was no significant difference concerning the complication rates which needed reoperations or revision surgery (odds ratio, 1.01; p = 0.99). KATKA components had a more femoral valgus (–1.8°; p < 0.0001), more tibial varus (1.2°; p = 0.0001), and more tibial slope (1.2°; p = 0.0001), all being statistically significantly different. Better clinical outcomes were obtained in KATKA and component placement in KATKA is significantly different from that in MATKA. There was no increase of patients with poor clinical results due to implant position especially for varus placement of tibial component. This systematic review of five RCTs suggests that KATKA is of potential alternative method to MATKA since the risk of revision for tibial loosening is negligible compared with MATKA for the same follow-up period.


2019 ◽  
Vol 24 (5) ◽  
pp. 558-571 ◽  
Author(s):  
Kartik Bhatia ◽  
Hans Kortman ◽  
Christopher Blair ◽  
Geoffrey Parker ◽  
David Brunacci ◽  
...  

OBJECTIVEThe role of mechanical thrombectomy in pediatric acute ischemic stroke is uncertain, despite extensive evidence of benefit in adults. The existing literature consists of several recent small single-arm cohort studies, as well as multiple prior small case series and case reports. Published reports of pediatric cases have increased markedly since 2015, after the publication of the positive trials in adults. The recent AHA/ASA Scientific Statement on this issue was informed predominantly by pre-2015 case reports and identified several knowledge gaps, including how young a child may undergo thrombectomy. A repeat systematic review and meta-analysis is warranted to help guide therapeutic decisions and address gaps in knowledge.METHODSUsing PRISMA-IPD guidelines, the authors performed a systematic review of the literature from 1999 to April 2019 and individual patient data meta-analysis, with 2 independent reviewers. An additional series of 3 cases in adolescent males from one of the authors’ centers was also included. The primary outcomes were the rate of good long-term (mRS score 0–2 at final follow-up) and short-term (reduction in NIHSS score by ≥ 8 points or NIHSS score 0–1 at up to 24 hours post-thrombectomy) neurological outcomes following mechanical thrombectomy for acute ischemic stroke in patients < 18 years of age. The secondary outcome was the rate of successful angiographic recanalization (mTICI score 2b/3).RESULTSThe authors’ review yielded 113 cases of mechanical thrombectomy in 110 pediatric patients. Although complete follow-up data are not available for all patients, 87 of 96 (90.6%) had good long-term neurological outcomes (mRS score 0–2), 55 of 79 (69.6%) had good short-term neurological outcomes, and 86 of 98 (87.8%) had successful angiographic recanalization (mTICI score 2b/3). Death occurred in 2 patients and symptomatic intracranial hemorrhage in 1 patient. Sixteen published thrombectomy cases were identified in children < 5 years of age.CONCLUSIONSMechanical thrombectomy may be considered for acute ischemic stroke due to large vessel occlusion (ICA terminus, M1, basilar artery) in patients aged 1–18 years (Level C evidence; Class IIb recommendation). The existing evidence base is likely affected by selection and publication bias. A prospective multinational registry is recommended as the next investigative step.


2020 ◽  
pp. bjsports-2020-102525
Author(s):  
Stefanos Karanasios ◽  
Vasileios Korakakis ◽  
Rod Whiteley ◽  
Ioannis Vasilogeorgis ◽  
Sarah Woodbridge ◽  
...  

ObjectiveTo evaluate the effectiveness of exercise compared with other conservative interventions in the management of lateral elbow tendinopathy (LET) on pain and function.DesignSystematic review and meta-analysis.MethodsWe used the Cochrane risk-of-bias tool 2 for randomised controlled trials (RCTs) to assess risk of bias and the Grading of Recommendations Assessment, Development and Evaluation methodology to grade the certainty of evidence. Self-perceived improvement, pain intensity, pain-free grip strength (PFGS) and elbow disability were used as primary outcome measures.Eligibility criteriaRCTs assessing the effectiveness of exercise alone or as an additive intervention compared with passive interventions, wait-and-see or injections in patients with LET.Results30 RCTs (2123 participants, 5 comparator interventions) were identified. Exercise outperformed (low certainty) corticosteroid injections in all outcomes at all time points except short-term pain reduction. Clinically significant differences were found in PFGS at short-term (mean difference (MD): 12.15, (95% CI) 1.69 to 22.6), mid-term (MD: 22.45, 95% CI 3.63 to 41.3) and long-term follow-up (MD: 18, 95% CI 11.17 to 24.84). Statistically significant differences (very low certainty) for exercise compared with wait-and-see were found only in self-perceived improvement at short-term, pain reduction and elbow disability at short-term and long-term follow-up. Substantial heterogeneity in descriptions of equipment, load, duration and frequency of exercise programmes were evident.ConclusionsLow and very low certainty evidence suggests exercise is effective compared with passive interventions with or without invasive treatment in LET, but the effect is small.PROSPERO registration numberCRD42018082703.


SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A139-A140
Author(s):  
Janannii Selvanathan ◽  
Chi Pham ◽  
Mahesh Nagappa ◽  
Philip Peng ◽  
Marina Englesakis ◽  
...  

Abstract Introduction Patients with chronic non-cancer pain often report insomnia as a significant comorbidity. Cognitive behavioral therapy for insomnia (CBT-I) is recommended as the first line of treatment for insomnia, and several randomized controlled trials (RCTs) have examined the efficacy of CBT-I on various health outcomes in patients with comorbid insomnia and chronic non-cancer pain. We conducted a systematic review and meta-analysis on the effectiveness of CBT-I on sleep, pain, depression, anxiety and fatigue in adults with comorbid insomnia and chronic non-cancer pain. Methods A systematic search was conducted using ten electronic databases. The duration of the search was set between database inception to April 2020. Included studies must be RCTs assessing the effects of CBT-I on at least patient-reported sleep outcomes in adults with chronic non-cancer pain. Quality of the studies was assessed using the Cochrane risk of bias assessment and Yates quality rating scale. Continuous data were extracted and summarized using standard mean difference (SMD) with 95% confidence intervals (CIs). Results The literature search resulted in 7,772 articles, of which 14 RCTs met the inclusion criteria. Twelve of these articles were included in the meta-analysis. The meta-analysis comprised 762 participants. CBT-I demonstrated a large significant effect on patient-reported sleep (SMD = 0.87, 95% CI [0.55–1.20], p &lt; 0.00001) at post-treatment and final follow-up (up to 9 months) (0.59 [0.31–0.86], p &lt; 0.0001); and moderate effects on pain (SMD = 0.20 [0.06, 0.34], p = 0.006) and depression (0.44 [0.09–0.79], p= 0.01) at post-treatment. The probability of improving sleep and pain following CBT-I at post-treatment was 81% and 58%, respectively. The probability of improving sleep and pain at final follow-up was 73% and 57%, respectively. There were no statistically significant effects on anxiety and fatigue. Conclusion This systematic review and meta-analysis showed that CBT-I is effective for improving sleep in adults with comorbid insomnia and chronic non-cancer pain. Further, CBT-I may lead to short-term moderate improvements in pain and depression. However, there is a need for further RCTs with adequate power, longer follow-up periods, CBT for both insomnia and pain, and consistent scoring systems for assessing patient outcomes. Support (if any):


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