scholarly journals Intra-Articular Injection of Autologous Adipose-Derived Stromal Vascular Fractions for the Cartilage Repair of Grade 2 and 3 Knee Osteoarthritis: A Confirmatory Clinical Trial

2021 ◽  
Author(s):  
Yin Zhang ◽  
Qing Bi ◽  
Taihen Yu ◽  
Zheping Hong ◽  
Yu Tong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Cartilage Repair ◽  
Clinical Symptoms ◽  
Rapid Development ◽  
Cartilage Regeneration ◽  
Substantial Improvement ◽  
Clinical Trial Registry ◽  
Knee Oa ◽  
Grade 3

Abstract BackgroundCartilage defect remains one of the most important reasons for the rapid development of knee osteoarthritis (OA). Numerous reports have confirmed the safety and clinical efficacy of autologous adipose-derived stromal vascular fractions (SVF), which has recently been used clinically to treat patients with knee OA. However, there is still no consensus as to whether SVF can promote cartilage regeneration. Herein, we purposed to evaluate the effectiveness of SVF in cartilage regeneration by developing cartilage model based on the 3D-FS-SPGR sequence.MethodsPatients with Kellgren-Lawrence grade 2-3 knee OA were recruited in our research. Then, we monitored patients and subsequently scored symptoms using WOMAC, VAS, and range of motion (ROM) before treatment and at 1, 3, 6, and 12 months post-treatment. The WORMS and MOCART were recorded by magnetic resonance imaging. The cartilage model of the patient was established using the 3D-FS-SPGR sequence, while the relevant parameters of the model were counted at baseline, 6, and 12 months.ResultsWe enrolled 47 patients (53 knees) with knee OA in this study, of which 29 knees were classified as grade 2, while 24 were assigned grade 3. No treatment-related adverse event was observed in our study. Notably, WOMAC, VAS, and ROM showed a significant improvement at 12 months. We further found that the thickness, volume, and surface of the cartilage defect decreased, while the volume of healthy cartilage increased in all regions, particularly in the medial femoral and tibia condyle. Moreover, the scores of WORMS and MOCART revealed a substantial improvement of cartilage repair at 12 months. ConclusionsTaken together, this study shows that intra-articular injection of SVF into the knee markedly improved the clinical symptoms of patients without the occurrence of adverse events, thereby repairing the damaged articular cartilage through cartilage regeneration.Trial registrationRetrospectively registered. Chinses Clinical Trial Registry with identifier ChiCTR2100042930. Registered 28 January 2021.

scholarly journals Mesenchymal stem cells - a promising strategy for treating knee osteoarthritis

2020 ◽  
Vol 9 (10) ◽  
pp. 719-728
Author(s):  
Jiaqian Wang ◽  
Liang Zhou ◽  
Yong Zhang ◽  
Lixin Huang ◽  
Qin Shi
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Knee Osteoarthritis ◽  
Low Dose ◽  
Meta Analysis ◽  
Cartilage Regeneration ◽  
Cochrane Library ◽  
P Values ◽  
Knee Oa ◽  
Primary Evaluation

Aims The purpose of our study was to determine whether mesenchymal stem cells (MSCs) are an effective and safe therapeutic agent for the treatment of knee osteoarthritis (OA), owing to their cartilage regeneration potential. Methods We searched PubMed, Embase, and the Cochrane Library, with keywords including “knee osteoarthritis” and “mesenchymal stem cells”, up to June 2019. We selected randomized controlled trials (RCTs) that explored the use of MSCs to treat knee OA. The visual analogue scale (VAS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), adverse events, and the whole-organ MRI score (WORMS) were used as the primary evaluation tools in the studies. Our meta-analysis included a subgroup analysis of cell dose and cell source. Results Seven trials evaluating 256 patients were included in the meta-analysis. MSC treatment significantly improved the VAS (mean difference (MD), –13.24; 95% confidence intervals (CIs) –23.28 to –3.20, p = 0.010) and WOMAC (MD, –7.22; 95% CI –12.97 to –1.47, p = 0.010). The low-dose group with less than 30 million cells showed lower p-values for both the VAS and WOMAC. Adipose and umbilical cord–derived stem cells also had lower p-values for pain scores than those derived from bone marrow. Conclusion Overall, MSC-based cell therapy is a relatively safe treatment that holds great potential for OA, evidenced by a positive effect on pain and knee function. Using low-dose (25 million) and adipose-derived stem cells is likely to achieve better results, but further research is needed. Cite this article: Bone Joint Res 2020;9(10):719–728.

scholarly journals Association between vitamin D concentrations and knee pain in patients with osteoarthritis

PeerJ ◽  
2018 ◽  
Vol 6 ◽  
pp. e4670 ◽  
Author(s):  
Murat Cakar ◽  
Semih Ayanoglu ◽  
Haluk Cabuk ◽  
Metin Seyran ◽  
Suleyman Semih Dedeoglu ◽  
...  
Keyword(s):  
Vitamin D ◽  
Knee Pain ◽  
Clinical Symptoms ◽  
Serum Vitamin ◽  
Womac Score ◽  
Mean Values ◽  
Hydroxyvitamin D ◽  
Serum Vitamin D ◽  
Knee Oa ◽  
Grade 3

Objectives Osteoarthritis (OA) and vitamin D deficiency are common health conditions in older people. Whether vitamin D concentration is associated with knee OA is controversial. In this study, we aimed to determine the association between serum concentrations of vitamin D and osteoarthritic knee pain. Subjects and Methods Vitamin D concentrations were measured with the 25 hydroxyvitamin D test in patients presenting with clinical symptoms of primary knee osteoarthritis. Osteoarthritis was graded on the Kellgren-Lawrence grading scale from anteroposterior and lateral radiographs. Height, weight, and body mass index (BMI) were recorded. Patients completed a 10-cm visual analogue scale (VAS) for indicating pain and the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Vitamin D concentration was defined as severely deficient (<10 ng/mL), insufficient (10 to 19 ng/mL), or normal (20 to 50 ng/mL). Results Of 149 patients (133 women), the mean age was 63.6 years. Mean vitamin D concentration was 11.53 ng/mL, and 90% patients were vitamin D deficient. Mean WOMAC score was 57.2, and VAS pain score was 7.5. Kellgren-Lawrence grade was 2 for 10 patients, grade 3 for 61, and grade 4 for 88. Mean BMI was 33.4. Mean values of VAS, WOMAC, and BMI did not differ by vitamin D status. Conclusion Serum vitamin D concentration is not associated with knee pain in patients with osteoarthritis.

scholarly journals A Double-Blind, Active-Controlled Clinical Trial of Sodium Bicarbonate and Calcium Gluconate in the Treatment of Bilateral Osteoarthritis of the Knee

2017 ◽  
Vol 10 ◽  
pp. 117954411668889 ◽  
Author(s):  
María del Carmen Caamaño ◽  
Sandra García-Padilla ◽  
Miguel Ángel Duarte-Vázquez ◽  
Karla Elena González-Romero ◽  
Jorge L Rosado
Keyword(s):  
Clinical Trial ◽  
Sodium Bicarbonate ◽  
Knee Osteoarthritis ◽  
Calcium Gluconate ◽  
Controlled Clinical Trial ◽  
Osteoarthritis Of The Knee ◽  
Short Term ◽  
Double Blind ◽  
Knee Oa ◽  
Double Blind Clinical Trial

Objective: To evaluate the effect of intra-articular injections of sodium bicarbonate with a single (SBCG1) or double dose (SBCG2) of calcium gluconate administered monthly compared with methylprednisolone (MP) for treatment of knee osteoarthritis. Methods: A 3-month, randomized, double-blind clinical trial with patients diagnosed with knee osteoarthritis (OA). The outcome variables were the Western Ontario-McMaster University Osteoarthritis Index (WOMAC) and the Lequesne functional index. Results: After 3 months, all treatments significantly improved in overall WOMAC and Lequesne scores. Mean changes (95% confidence interval) in WOMAC total score and the Lequesne index, respectively, for SBCG1 (−12.5 [−14.3, −10.7]; −9.0 [−11.4, −6.7]) and SBCG2 (−12.3 [−14.3, −10.4]; −8.9 [−10.4, −7.4]) were significantly greater than for MP (−5.0 [−7.2, −2.8]; −3.2 [−4.9, −1.5]) ( P < .001). Conclusions: Intra-articular injections of sodium bicarbonate and calcium gluconate are useful for short-term relief of OA symptoms in patients with bilateral knee osteoarthritis. Both treatments are more effective than MP injections in the reduction of knee OA symptoms. Trial Registration: Clinicaltrials.gov NCT00977444

scholarly journals Association between Vitamin D Concentrations and Knee Pain in Patients with Osteoarthritis

2017 ◽  
Vol 5 (2_suppl2) ◽  
pp. 2325967117S0008
Author(s):  
Murat Çakar ◽  
Semih Ayanoğlu ◽  
Haluk Çabuk ◽  
Metin Seyran ◽  
Süleyman Semih Dedeoğlu ◽  
...  
Keyword(s):  
Vitamin D ◽  
Knee Pain ◽  
Clinical Symptoms ◽  
Serum Vitamin ◽  
Womac Score ◽  
Mean Values ◽  
Hydroxyvitamin D ◽  
Serum Vitamin D ◽  
Knee Oa ◽  
Grade 3

Objectives: Osteoarthritis (OA) and vitamin D deficiency are common health conditions in older people. Whether vitamin D concentration is associated with knee OA is controversial. In this study, we aimed to determine the association between serum concentrations of vitamin D and osteoarthritic knee pain. Subjects and Methods: Vitamin D concentrations were measured with the 25 hydroxyvitamin D test in patients presenting with clinical symptoms of primary knee osteoarthritis. Osteoarthritis was graded on the Kellgren-Lawrence grading scale from anteroposterior and lateral radiographs. Height, weight, and body mass index (BMI) were recorded. Patients completed a 10-cm visual analogue scale (VAS) for indicating pain and the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Vitamin D concentration was defined as severely deficient (<10 ng/mL), insufficient (10 to 19 ng/mL), or normal (20 to 50ng/mL). Results: Of 149 patients (133 women) the mean age was 63.6 years. Mean vitamin D concentration was 11.53 ng/mL, and 90% patients were Vitamin D deficient. Mean WOMAC score was 57.2, and VAS pain score was 7.5. Kellgren-Lawrence grade was 2 for 10 patients grade 3 for 61, and grade 4 for 88. Mean BMI was 33.4. Mean values of VAS, WOMAC, and BMI did not differ by vitamin D status. Conclusion: Serum vitamin D concentration is not associated with knee pain in patients with osteoarthritis.

scholarly journals Arthroscopic Cartilage Regeneration Facilitating Procedure: A Decompressing Arthroplasty for Knee Osteoarthritis

2020 ◽  
Author(s):  
Shaw-Ruey Lyu ◽  
Jung-pin Hung ◽  
Chia-Chen Hsu ◽  
Yu-Ruei Chen ◽  
Chih-Wen Lin
Keyword(s):  
Knee Osteoarthritis ◽  
Cartilage Regeneration ◽  
Outcome Study ◽  
Knee Oa ◽  
Radiographic Outcomes ◽  
Operative Care ◽  
Medial Plica ◽  
Magnetic Resonance Imaging Mri ◽  
Objective Outcomes ◽  
One Year

Abstract Background The effectiveness of arthroscopic treatment for knee osteoarthritis (OA) has been subject to debate. This study presents an innovative concept of arthroscopic management for knee OA and investigates its clinical outcome.Methods An arthroscopic cartilage regeneration facilitating procedure (ACRFP) to eliminate medial abrasion phenomenon and decompress the patello-femoral joints was performed on 693 knees of 411 patients with knee OA, mean age 60 years (34-90). The Knee Society score (KSS) and the knee injury and osteoarthritis outcome score (KOOS) were used for subjective outcome study. Roentgenographic changes for all cases and magnetic resonance imaging (MRI) variations for twenty randomly selected cases were evaluated for objective outcomes. Results There were 634 knees in 369 patients (93.7%) available with more than 3 years of follow-ups (mean 40 months, SD 9). The overall subjective satisfactory rate was 91.1%. The KSS and all subscales of the KOOS improved statistically. Reversal of the degeneration process of cartilage was observed in 80.1% of the whole series (radiographic outcome) and in 72.2% of the 18 randomly selected cases (one-year MRI outcome study). Gender and OA severity were related to subjective outcomes. Age, body mass index (BMI), pre-operative hyaluronic acid injection, OA severity, and the type and severity of the medial plica are important predictors of radiographic outcomes. An analysis of failed cases reaffirmed the need for early ACRFP and skillful post-operative care. Conclusion ACRFP is an effective treatment for knee OA. If performed in time, it can satisfy most patients and might modify their degeneration process.

scholarly journals Transcranial magnetic stimulation associated with manual therapy in patients with knee osteoarthritis: a randomized controlled clinical trial protocol

2020 ◽  
pp. 1-4
Author(s):  
Mannaly Mendonça ◽  
Maria das Graças Araújo ◽  
Camilla Fonseca ◽  
Maíra Lima, Luiz Mèlo ◽  
Sérgio Rocha ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Transcranial Magnetic Stimulation ◽  
Knee Osteoarthritis ◽  
Manual Therapy ◽  
Magnetic Stimulation ◽  
Treatment Protocol ◽  
Controlled Clinical Trial ◽  
Knee Oa ◽  
Before And After ◽  
Registration Number

Background: Persistent pain in knee osteoarthritis (KOA) may generate sensitization of the afferent and central nervous system (CNS) pathways over time. Therefore, for patients with chronic pain derived from KOA, to associate therapies that address peripheral impairment, such as central and manual therapy and transcranial magnetic stimulation seems to be a promising strategy for pain reduction. Objectives: The purpose of this study is to unite rTMS and TM to control the pain of patients with knee OA and to examine the efficacy of this treatment protocol, assuming that this union would be more beneficial than the formally applied therapies isolated. Methods: This clinical trial with three arms interventions, controlled, triple blind and randomized, will allocate patients with KOA in groups (i) transcranial magnetic stimulation; (ii) sham transcranial magnetic stimulation + manual therapy and (iii) transcranial magnetic stimulation + manual therapy. Pain assessment will be performed using the visual analog scale of pain of 100 points, before and after the interventions, and for a maximum of 30 days after the single session. This session will involve the application of real or fictitious transcranial magnetic stimulation followed by manual or home therapy. Discussion: The study is in the recruitment stage and it is expected that after the application of the therapeutic protocol the group that performed the association has a more significant improvement in comparison to the others. Study registry: The protocol of this study was published on the Clinical Trials (www.clinicaltrials.org), with the registration number NCT03076294.

scholarly journals Characterisation of current pharmacotherapeutic COVID-19 clinical trials in India: A registry-based descriptive analysis

2021 ◽  
Vol 65 ◽  
pp. 141-145
Author(s):  
Arkapal Bandyopadhyay ◽  
Chahat Choudhary ◽  
Akash Agnihotri ◽  
Shailendra Handu
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Study Design ◽  
Clinical Symptoms ◽  
Descriptive Analysis ◽  
Current Trend ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Plasma Therapy ◽  
Broad Perspective

COVID-19 has emerged as a global pandemic. There is currently a spurt of clinical research to generate evidence to treat this novel disease. The aim of the current study is to characterise the pharmacotherapeutic intervention-related clinical trials registered in India. COVID-19 clinical trials registered in India were analysed from data retrieved from Clinical Trial Registry-India, ClinicalTrials.gov and International Clinical Trial Registry Platform. Parameters such as study design, sample size, pharmacotherapeutic interventions and primary outcomes were evaluated. A total of 267 studies were screened among which 103 clinical trials were assessed for descriptive analysis. Majority of registered trials (55.3%) were in Indian System of Medicine followed by antimalarials such as hydroxychloroquine/chloroquine (10.5%) and plasma therapy (7.1%). Most commonly used study design was randomised parallel group in 63%. Open-label study was seen in 47.5%. Primary outcome was improvement of clinical symptoms in 46.6% followed by rate and time of viral load reduction in 18.2%. Maharashtra (n = 35) followed by Delhi (n = 29) had the maximum number of registered trial sites. The study gives broad perspective on the current trend of clinical trials on COVID-19 being conducted in India. The outcomes of these trials will lead to generation of valuable data for evidence-based treatment of COVID-19.

scholarly journals Neurological and psychological mechanisms of the specific and nonspecific effects of acupuncture on knee osteoarthritis: study protocol for a randomized, controlled, crossover trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Jin-Ling Li ◽  
Cun-Zhi Liu ◽  
Na Zhang ◽  
Chao-Qun Yan ◽  
Jian-Feng Tu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Psychological Factors ◽  
Acupuncture Treatment ◽  
Brain Activity ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Nonspecific Effects ◽  
Acupuncture Effects ◽  
The Brain

Abstract Background Acupuncture, as one of the promising non-pharmacological interventions, has been proved to be beneficial for patients. However, the magnitude of acupuncture’s specific and nonspecific effects, as well as their neurological and psychological determinants, remains unclear. Therefore, this study is designed to examine the acupuncture efficacy, investigate whether the brain mechanisms between the specific and nonspecific effects of acupuncture are different, and to evaluate how psychological factors affect the acupuncture effects. Methods This is a randomized, controlled, crossover clinical trial. A total of 60 patients with knee osteoarthritis will receive 4 weeks of acupuncture treatment and 4 weeks of sham acupuncture treatment in a random order separated by a washout period of 2 weeks. The changes in clinical characteristics based on pain-related scales will be assessed to investigate the clinical efficacy of acupuncture. Resting state functional magnetic resonance imaging (fMRI) scans will be used to identify the brain activity changes related to the specific and nonspecific effects of acupuncture. The questionnaires of psychological factors will be used to evaluate patients’ psychological properties. Correlation and mediation analyses will be conducted among psychological factors, brain activity changes, and symptoms improvement to explore the neurological and psychological correlates of the acupuncture effects. Discussion This study will concentrate on distinguishing and clarifying the specific and nonspecific effects of acupuncture. The results of this study may contribute to rationally optimize the acupuncture therapies by flexible application of the specific and nonspecific effects of acupuncture. Trial registration Chinese Clinical Trial Registry ChiCTR1900025807. Registered on 9 September 2019

scholarly journals Effect of Dextrose Prolotherapy, Platelet Rich Plasma and Autologous Conditioned Serum on Knee Osteoarthritis: A Randomized Clinical Trial

2020 ◽  
Author(s):  
Alireza Pishgahi ◽  
Rozita Abolhasan ◽  
Seyed Kazem Shakouri ◽  
Mohammad Sadegh Soltani-Zangbar ◽  
Shahla Dareshiri ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Randomized Clinical Trial ◽  
Platelet Rich Plasma ◽  
Womac Score ◽  
Knee Function ◽  
Post Intervention ◽  
Knee Oa ◽  
Autologous Conditioned Serum ◽  
And Function

Knee osteoarthritis (OA) is one of the common degenerative articular disorders that are related to decreased quality of life. Currently, novel biologic therapeutic approaches are introduced in the literature for OA management. In this study, the clinical efficiency of Dextrose prolotherapy, platelet-rich plasma (PRP) and autologous conditioned serum (ACS) injection on the level of pain and function in Knee OA were compared. A randomized clinical trial was directed on 92 knee OA patients. Patients were randomly divided into three groups: 30 were received dextrose prolotherapy once in a week for three weeks, 30 received autologous PRP for two times with seven days interval, and in the remaining 32 patients 2ml of ACS were injected two times every seven days. Study participants were measured through the Western Ontario and McMaster Universities (WOMAC) score, the visual analogue scale (VAS), at baseline, 1 and 6 months post-intervention. Both ACS and PRP treated patients showed improvement in pain intensity and knee function during 1 and 6 months pursue; however, this progress was more significant in the ACS group. Dextrose prolotherapy showed no substantial changes in pain and function of the affected knee in treated patients. Treatment of Knee OA with ACS and PRP injections are associated with pain reduction and knee function improvement. Not only, ACS therapy is more effective than that of PRP, but also due to its less variability in processing and less reported side effects, it could be considered as a safe and effective non-surgical alternative for OA management.  

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