Comparison of Two Different Ozone Injection Sites for Knee Osteoarthritis, Tibio-femoral Joint versus Supra-patellar Recess: An Open Randomized Clinical Trial

Background: The aim of this study was to compare the efficacy of ozone injection at Tibio-femoral joint with Supra-patellar recess on knee osteoarthritis (OA). Methods: In this randomized, controlled clinical trial, 99 patients with symptomatic knee OA were randomized into two groups. 47 patients selected to receive 7-8 ml ozone (20 µg/ml) through Tibio-femoral joint injection, and 49 patients received 10 ml ozone (20 µg/ml) through supra-patellar recess injection by using in-plane ultrasound-guided. The primary outcome was the change from baseline in the visual analogue scale (VAS) (0-100 mm) pain score during 3 months after injection. Secondary outcome measures included the Western Ontario and McMaster universities OA Index (WOMAC), Lequesne index, time “Up and Go” (TUG) test, single-limb stance (SLS) tests, patient satisfaction, and adverse effects. All of these measurements were evaluated at the base time, 48 hours, 2 weeks, 1 month, 2 months, and 3 months after injection. Results: Both groups had significantly improvement in the primary and secondary outcome measures. VAS pain score except at the 3–month follow-up (16.8±13.3 versus 18.1±16.6, 95% CI, -7.33 to 4.73, p =0.6), WOMAC pain score, WOMAC stiffness score at all evaluated times, and WOMAC total score at 48 hours after injection (95% CI, -19.4 to -4.9) were significantly better among Tibio-femoral ozone injection compare to Supra-patellar recess injection (95% CI, -20.68 to -6.51, p<0.001)). In both groups satisfaction, TUG and SLS times were improved, but no significant difference was seen between groups (p>0.05). At the 3-month follow-up, WOMAC pain and total scores for only Tibio-femoral joint injection group as well as WOMAC function, TUG and SLS times for both groups were gradually coming back to the baseline. Conclusion: Ozone injection in both groups was associated with pain relief, functional improvement, and quality of life in patient with knee OA. Pain and stiffness of joint were improved better in Supra-patellar recess ozone injection.

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T2 mapping evaluation of changes in cartilage matrix after PRP and HA injection therapy in knee osteoarthritis: a prospective, randomized, double blind, placebo controlled study

10.21203/rs.3.rs-36493/v1 ◽

2020 ◽

Author(s):

Matjaz Vogrin ◽

Jakob Naranda ◽

Mario Gorenjak ◽

Tomaz Bajec ◽

Domen Mongus ◽

...

Keyword(s):

Placebo Group ◽

Knee Osteoarthritis ◽

Pain Score ◽

T2 Mapping ◽

Womac Score ◽

Controlled Study ◽

Womac Pain ◽

Womac Pain Score ◽

Knee Oa

Abstract BackgroundIn this study we focused on evaluating the effect of intra-articular platelet-rich plasma (PRP) and hyaluronic acid (HA) on the qualitative and quantitative properties of the articular cartilage in patients with knee osteoarthritis (OA).MethodsWe evaluated 264 patients undergoing treatment of moderate knee OA. Patients aged between 40 and 70 years were included with articular K-L stage ≤ 2. Patients were randomized into three groups and treated with three doses of intra-articular PRP, HA, or placebo injection. Patients were evaluated clinically and by using T2 mapping.ResultsBoth PRP (619.05 ± 243 ms; p = 2.7 × 10− 5) and HA (637.12 ± 273 ms; p = 1.×10− 4) group showed statistically significant lower post-application T2 relaxation times in comparison to the placebo group (859.80 ± 406 ms).Cartilage thickness increased significantly after PRP (2.41±0.87 vs. 2.58±0.97 mm, p=0.033) and HA (2.28±0.81 vs. 2.80±1.00 mm, p=1.8×10) applications. There was a significant decrease in WOMAC pain score by 30% (p=0,001) and the overall WOMAC score by 27 p=1.9×10-4%) in PRP group. The decrease in WOMAC pain score and the overall WOMAC score in the placebo group was similar to the results observed in the PRP group. In the HA group a significant decrease in WOMAC pain score by 14% (p=0,005) was observed only at the first follow-up, whereas no difference was observed at the second follow-up. ConclusionsT2 mapping of cartilage tissue may aid to monitor its properties after the intra-articular therapies in knee OA. However, there is a discrepancy between clinical findings and the results of T2 mapping, suggesting questionable grounds for applying intra-articular therapy.

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Comparative study between the effect of neural versus intra-articular dextrose prolotherapy on pain and disability in patients with knee osteoarthritis

Egyptian Rheumatology and Rehabilitation ◽

10.1186/s43166-021-00079-w ◽

2021 ◽

Vol 48 (1) ◽

Author(s):

Rehab A. Sallam ◽

Aya A. Abdelkhabir ◽

Adel A. Shabana

Keyword(s):

Knee Osteoarthritis ◽

Womac Pain ◽

Knee Oa ◽

Natural Substances ◽

Group I ◽

Skin Targeting ◽

Vas Scores ◽

Group Ii ◽

Reduced Mobility

Abstract Background Osteoarthritis (OA) is a degenerative disease which presents with joint pain and stiffness and reduced mobility. Knee OA is the commonest cause of disability in adults. Dextrose prolotherapy is a new option used to treat mild-to-moderate knee OA. Neural prolotherapy (NPT) is multiple small injections under the skin targeting painful areas with natural substances. The aim of work was to evaluate and compare neural prolotherapy versus intra-articular dextrose prolotherapy effect on relieving pain and improving disability of knee OA. Results VAS and WOMAC scores improved significantly immediately and at 3 and at 6 months, respectively, in group I compared with group II (P < 0.001). The decrease in VAS scores and all the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores in group I along the follow-up period in comparison with the baseline scores was statistically significant (P < 0.001). In group II, only WOMAC pain and stiffness scores improved significantly. ROM showed insignificant increase in both groups at 3 and 6 months assessment. On follow-up, range of motion increased in both groups and reached significance in group I (P = .002). Conclusion Dextrose prolotherapy both intra-articular and periarticular (neural) is a very effective and cheap therapy for knee OA with good patient selection. Neural prolotherapy significantly relieves pain and improves function in patients with knee osteoarthritis when compared with intra-articular prolotherapy thus avoiding hazards of intra-articular knee injections.

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Intra Articular Ozone Modulates Inflammation and Has Anabolic Effect on Knee Osteoarthritis: IL-6 and IGF-1 as Pro-Inflammatory and Anabolic Biomarkers

Processes ◽

10.3390/pr10010138 ◽

2022 ◽

Vol 10 (1) ◽

pp. 138

Author(s):

Marcos E. Fernández-Cuadros ◽

Olga S. Pérez-Moro ◽

María J. Albaladejo-Florín ◽

María M. Tobar-Izquierdo ◽

Amelia Magaña-Sánchez ◽

...

Keyword(s):

Uric Acid ◽

Knee Osteoarthritis ◽

Real World ◽

Secondary Outcome ◽

Womac Pain ◽

Anabolic Effect ◽

Obese Patients ◽

Knee Oa ◽

Before And After ◽

Anti Inflammatory

Objectives: (1) to demonstrate the anti-inflammatory and anabolic effect of Ozone by determining in serum samples the biochemical levels of IL-6 and IGF-1 in knee osteoarthritis (OA) patients in a real world rehabilitation setting; (2) to differentiate Ozone effect in diabetic (DM)/obese and non-DM/non-obese patients; (3) to evaluate clinical effectiveness by visual analog scale (VAS) and WOMAC scale, and biochemical effect by C-reactive protein (CRP), uric acid and erythrocyte sedimentation rate (ESR). Material and methods: 65 patients with knee OA Kellgren Lawrence (KL) grade 2 or more were analyzed in a retrospective observational study. The study ran from January 2018 to September 2021. Inclusion criteria: (a) patients 18 years or older; (b) with knee OA KL 2° or more; (c) biochemical analysis before-and-after treatment; (d) pain more than 3 on VAS. Exclusion Criteria: (a) previous knee surgery; (b) favism; (c) pregnancy; (d) any other disease that originates lack of collaboration for infiltration. Primary Outcome variables: (a) IL-6; (b) IGF-1 in diabetes mellitus (DM)/obese and non-DM/non-obese patients; both before-and-after Ozone treatment. Secondary Outcome variables: (a) CRP, (b) ESR, (c) uric acid, (d) VAS pain, (e) WOMAC pain, function and stiffness. Ozone protocol consisted of four sessions (once a week) of an intra-articular infiltration of 20 mL (20 µg/mL concentration) of a gas mixture of Oxygen-Ozone 95-5% (produced by Ozone generator Ozonosan-α Plus®). For biochemical evaluation, SNIBE MAGLUMI ™ IL-6 (CLIA) and SNIBE MAGLUMI ™ IGF-1 (CLIA) kits were used. CRP and uric acid were analyzed by a Abbott Alinity c kit; and ESR was evaluated by DIESSE VES MATIC CUBE 30. Results: There is a linear correlation between age and OA severity. IL-6 decreased both in DM and non-DM patients and in all OA KL grades (from 2.70 to 1.59 pg/mL). IGF-1 decreased in total group (OA + DM + obesity) from 112.09 to 107.19 ng/mL. When only non-DM/non-obese knee OA patients were analyzed, Ozone improved IGF-1 levels (from 100.17 to 102.03 ng/mL). Ozone decreased CRP, ESR, uric acid, and improved VAS pain, WOMAC pain, function and stiffness (p < 0.05). Conclusions: Ozone is a valid option for the management of knee osteoarthritis in a real world rehabilitation setting, because of its anti-inflammatory, metabolic and anabolic properties. Ozone tends to downregulate pro-inflammatory IL-6 cytokine. Ozone has a metabolic/hypoglycemic effect on obese/diabetic knee osteoarthritis patients by reducing IGF-1. Ozone has an anabolic effect on non-diabetic/non-obese patients by improving IGF-1. Ozone reduces other biomarkers of inflammation (CRP, ESR and uric acid) and improves, pain, function and quality of life.

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Efficacy and Safety of Tongning Gel for Knee Osteoarthritis: A Multicentre, Randomized, Double-Blinded, Parallel, Placebo-Controlled, Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/8707256 ◽

2020 ◽

Vol 2020 ◽

pp. 1-9

Author(s):

Ye Zhao ◽

Zhi Bi Shen ◽

Ji Rong Ge ◽

Wen Gang Liu ◽

Jun Xing Yang ◽

...

Keyword(s):

Clinical Trial ◽

Adverse Events ◽

Knee Osteoarthritis ◽

Physical Function ◽

Pain Score ◽

Adverse Reactions ◽

Control Group ◽

Womac Pain ◽

Womac Pain Score ◽

Experimental Group

Objective. To evaluate the efficacy and safety of Tongning Gel (TNG) compared to placebo-controlled (PC) for knee osteoarthritis (KOA). Methods. A multicentre, randomized, double-blinded, parallel, placebo-controlled, clinical trial was performed in 576 patients (432 patients in the TNG group, 144 patients in the PC group), and 1 in the experimental group withdrew due to nonuse of drug. Patients were randomized to receive TNG or PC applied to knee skin at 3g per time, 2 times per day, which lasted for 3 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score was used to evaluate the primary efficacy of TNG and WOMAC stiffness and physical function and total scores were used to evaluate the secondary efficacy of TNG. All participants who received at least one dose of study drug were included in the safety analysis. This trial has been registered in Chinese Clinical Trial Registry (no. CTR20131276). Results. Primary efficiency outcome: there were significant differences in the decreased value of WOMAC pain score between two groups (P<0.05), and the decreased value of WOMAC pain score in the TNG group were better than those in the PC group (P<0.05). Secondary efficiency outcome: the WOMAC total score, WOMAC stiffness score, WOMAC physical function score, and the decrease of the above indexes of the two groups of patients after treatment were statistically significant (P<0.05), and the improvement of the above indexes in the TNG group was better than that of the PC group (P<0.05). Safety Evaluation. A total of 42 adverse events were reported by 29 patients: 25 adverse events reported by 16 patients (3.71%) in the experimental group and 17 adverse events were reported by 13 patients (9.03%) in the control group. And 8 adverse reactions were reported by 6 patients including 2 adverse reactions by 2 patients (0.46%) in the experimental group and 6 adverse reactions by 4 patients (2.78%) in the control group. Two cases of significant adverse events occurred in the experimental group. Both groups had one serious adverse event, respectively, which were not relevant to the intervention. Conclusion. These results of the trial demonstrate that TNG is superior to placebo in the treatment of patients with KOA, and TNG can improve other symptoms of KOA, such as stiffness and physical function. TNG is safe for the treatment of knee osteoarthritis as a whole.

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Multicenter Randomized Clinical Trial Evaluating the Effectiveness of the Lokomat in Subacute Stroke

Neurorehabilitation and Neural Repair ◽

10.1177/1545968308326632 ◽

2008 ◽

Vol 23 (1) ◽

pp. 5-13 ◽

Cited By ~ 374

Author(s):

Joseph Hidler ◽

Diane Nichols ◽

Marlena Pelliccio ◽

Kathy Brady ◽

Donielle D. Campbell ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Outcome Measures ◽

Walking Speed ◽

Gait Training ◽

Secondary Outcome ◽

Walking Ability ◽

Robotic Assisted ◽

Subacute Stroke

Objective. To compare the efficacy of robotic-assisted gait training with the Lokomat to conventional gait training in individuals with subacute stroke. Methods. A total of 63 participants <6 months poststroke with an initial walking speed between 0.1 to 0.6 m/s completed the multicenter, randomized clinical trial. All participants received twenty-four 1-hour sessions of either Lokomat or conventional gait training. Outcome measures were evaluated prior to training, after 12 and 24 sessions, and at a 3-month follow-up exam. Self-selected overground walking speed and distance walked in 6 minutes were the primary outcome measures, whereas secondary outcome measures included balance, mobility and function, cadence and symmetry, level of disability, and quality of life measures. Results. Participants who received conventional gait training experienced significantly greater gains in walking speed ( P = .002) and distance ( P = .03) than those trained on the Lokomat. These differences were maintained at the 3-month follow-up evaluation. Secondary measures were not different between the 2 groups, although a 2-fold greater improvement in cadence was observed in the conventional versus Lokomat group. Conclusions. For subacute stroke participants with moderate to severe gait impairments, the diversity of conventional gait training interventions appears to be more effective than robotic-assisted gait training for facilitating returns in walking ability.

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Comparing efficacy of intraarticular single crosslinked Hyaluronan (HYAJOINT Plus) and platelet-rich plasma (PRP) versus PRP alone for treating knee osteoarthritis

Scientific Reports ◽

10.1038/s41598-020-80333-x ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Shu-Fen Sun ◽

Guan-Chyun Lin ◽

Chien-Wei Hsu ◽

Huey-Shyan Lin ◽

I.-H.siu Liou ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Platelet Rich Plasma ◽

Controlled Trial ◽

Pain Reduction ◽

Womac Pain ◽

Knee Oa ◽

Lequesne Index ◽

Injection Group ◽

The One

AbstractIntraarticular hyaluronan or platelet-rich plasma (PRP) is widely used in the treatment of knee osteoarthritis (OA). The efficacy of combined hyaluronan with PRP remained inconclusive. This study aimed to investigate the efficacy of combined a single crosslinked hyaluronan (HYAJOINT Plus) and a single PRP versus a single PRP in patients with knee OA. In a prospective randomized-controlled trial, 85 patients with knee OA (Kellgren-Lawrence 2) were randomized to receive a single intraarticular injection of HYAJOINT Plus (3 ml, 20 mg/ml) followed by 3 ml PRP (the combined-injection group, N = 43) or a single injection of 3 ml PRP (the one-injection group, N = 42). The primary outcome was the change from baseline in the visual analog scale (VAS) pain (0–00 mm) at 6 months. Secondary outcomes included The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale), Lequesne index, single leg stance test (SLS), use of rescue analgesics and patient satisfaction at 1, 3 and 6 months. Seventy-eight patients were available for the intention-to-treat analysis at 6 months. Both groups improved significantly in VAS pain, WOMAC, Lequesne index and SLS at each follow-up visit (p < 0.001). Patients receiving a single PRP experienced significantly greater improvements in VAS pain than patients receiving combined injections at 1-month follow-up (adjusted mean difference: − 5.6; p = 0.017). There were no significant between-group differences in several of the second outcomes at each follow-up visit, except the WOMAC-pain and WOMAC-stiffness scores favoring the one-injection group at 1 month (p = 0.025 and p = 0.011). However, at 6-month follow-up, the combined-injection group achieved significantly better VAS pain reduction (p = 0.020). No serious adverse events occurred following injections. In conclusion, either combined injections of HYAJOINT Plus and PRP or a single PRP alone was safe and effective for 6 months in patients with Kellgren-Lawrence 2 knee OA. Combined injections of HYAJOINT Plus and PRP achieved better VAS pain reduction than a single PRP at 6 months. The results indicating a long term benefit effect of a combination of HYAJOINT Plus and PRP in a particular subset of patients with moderate knee OA need to be replicated in larger trials.ClinicalTrials.gov number NCT04315103.

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Bioavailable turmeric extract for knee osteoarthritis: a randomized, non-inferiority trial versus paracetamol

Trials ◽

10.1186/s13063-021-05053-7 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Shubha Singhal ◽

Nazer Hasan ◽

Kirti Nirmal ◽

Rohit Chawla ◽

Shalini Chawla ◽

...

Keyword(s):

Adverse Events ◽

Knee Osteoarthritis ◽

Womac Score ◽

Secondary Outcome ◽

Womac Pain ◽

Knee Oa ◽

Turmeric Extract ◽

Tnf Α ◽

Pain Subscale ◽

And Function

Abstract Background To compare the efficacy and safety of bioavailable turmeric extract versus paracetamol in patients with knee osteoarthritis (OA). Methods In this randomized, non-inferiority, controlled clinical study, patients of knee OA were randomized to receive bioavailable turmeric extract (BCM-95®) 500 mg capsule two times daily or paracetamol 650 mg tablet three times daily for 6 weeks. The primary outcome measure was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The secondary outcome measures were WOMAC total, WOMAC stiffness, and WOMAC physical function scores. Responder analysis of individual patients at different levels (≥ 20%, ≥ 50%, and ≥ 70%) for WOMAC score was calculated. TNF alpha and CRP levels were evaluated and adverse events (AE) were also recorded. Results Seventy-one and seventy-three knee OA patients, respectively in bioavailable turmeric extract and paracetamol groups, completed the study. Non-inferiority (equivalence) test showed that WOMAC scores were equivalent in both the groups (p value < 0.05) in all the domains within the equivalence limit defined by effect size (Cohen’s d) of 0.5 whereas CRP and TNF-α were better reduced with turmeric extract than paracetamol. After 6 weeks of treatment, WOMAC total score, pain, stiffness, and function scores got a significant improvement of 23.59, 32.09, 28.5, and 20.25% respectively with turmeric extract. In the turmeric extract group, 18% of patients got more than 50% improvement and 3% of patients got more than 70% improvement in WOMAC pain and function/stiffness score and none of the patients in the paracetamol group met the criteria. CRP and TNF-α got significantly reduced (37.21 and 74.81% respectively) in the turmeric extract group. Adverse events reported were mild and comparatively less in the turmeric extract group (5.48%) than in the paracetamol group (12.68%). Conclusion The results of the study suggest that bioavailable turmeric extract is as effective as paracetamol in reducing pain and other symptoms of knee osteoarthritis and found to be safe and more effective in reducing CRP and TNF-α. Trial registration Clinical Trials Registry – India CTRI/2017/02/007962. Registered on 27 February 2017

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AB0878 THE COMPARISON EFFECTS OF INTRA-ARTICULAR INJECTION OF PLATELET RICH PLASMA (PRP), PLASMA RICH IN GROWTH FACTOR (PRGF), HYALURONIC ACID (HA), AND OZONE IN KNEE OSTEOARTHRITIS; A ONE YEAR RANDOMIZED CLINICAL TRIAL

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.513 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1744.3-1745

Author(s):

S. A. Raeissadat ◽

P. Ghazi Hosseini ◽

M. H. Bahrami ◽

R. Salman Roghani ◽

M. Fathi ◽

...

Keyword(s):

Clinical Trial ◽

Knee Osteoarthritis ◽

Randomized Clinical Trial ◽

Platelet Rich Plasma ◽

Therapeutic Effects ◽

Short Term ◽

Knee Oa ◽

The Mean

Background:Knee osteoarthritis (OA) as a common progressive degenerative condition is one of the most important leading causes of disability and relative dependence. Worldwide prevalence of symptomatic knee OA has estimated 3.8%. It affects more than 20% of over 45-year-old population. Among the minimally invasive methods recommended for knee OA management is intra-articular injections for which a large array of products have been used. Despite all the existing options, there is still no general consensus on the choice and priority of the best intra-articular injection in knee osteoarthritis.Objectives:Our study compare the short and long-term efficacy of the intra articular injections (IAIs) of hyaluronic acid (HA), platelet-rich plasma (PRP), plasma rich in growth factors (PRGF), and ozone in patients with knee osteoarthritis (OA).Methods:In this single-blinded randomized clinical trial, 238 patients with mild to moderate knee OA were randomized into4 groups of IAIs: HA (3 doses weekly), PRP (2 doses with 3 weeks interval), PRGF (2 doses with 3 weeks interval), and Ozone (3 doses weekly). Our outcome measures were the mean changes from baseline until 2,6, and 12 months post intervention in scores of visual analog scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index.Results:A total of 200 patients enrolled final analysis. The mean age of patients was 56.9 ± 6.3 years, and69.5% were women. In 2 months follow up, significant improvement of pain, stiffness, and function were seen in all groups compared to the baseline, but the ozone group had the best results(P<0.05). In 6 month follow up HA, PRP, and PRGF groups demonstrated better therapeutic effects in all scores in comparison with ozone (P<0.05).At the end of the 12th month, only PRGF and PRP groups had better results versus HA and ozone groups in all scores (P<0.05).Despite the fact that ozone showed better early results, its effects begin to wear off earlier than other products and ultimately disappear in 12 months.Conclusion:Ozone injection had rapid effects and better short-term results after 2 months, but its therapeutic effects did not persist after 6 months and at the 6-month follow up, PRP,PRGF and HA were superior to ozone. Only patients in PRP and PRGF groups improved symptoms persisted for 12 months. Therefore, these products could be the preferable choices for long-term management.References:[1]Wang-Saegusa A, Cugat R, Ares O, Seijas R, Cuscó X, Garcia-Balletbó M. Infiltration of plasma rich in growth factors for osteoarthritis of the knee short-term effects on function and quality of life. Archives of orthopaedic and trauma surgery. 2011;131(3):311-7.[2]De La Mata J. Platelet rich plasma.A new treatment tool for the rheumatologist?ReumatologíaClínica (English Edition). 2013;9(3):166-71.[3]Raeissadat SA, Rayegani SM, Sedighipour L, Bossaghzade Z, Abdollahzadeh MH, Nikray R, et al. The efficacy of electromyographic biofeedback on pain, function, and maximal thickness of vastus medialis oblique muscle in patients with knee osteoarthritis: a randomized clinical trial. Journal of pain research. 2018;11:2781.[4]Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: Part II. Arthritis & Rheumatism. 2008;58(1):26-35.[5]Tehrani-Banihashemi A, Davatchi F, Jamshidi AR, Faezi T, Paragomi P, Barghamdi M. Prevalence of osteoarthritis in rural areas of I ran: a WHO-ILAR COPCORD study. International journal of rheumatic diseases. 2014;17(4):384-8.[6]Rayegani SM, Raeissadat SA, Heidari S, Moradi-Joo M. Safety and effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis. Journal of lasers in medical sciences. 2017;8(Suppl 1):S12.Disclosure of Interests:None declared

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Return to Sport and Work after Randomization for Knee Distraction versus High Tibial Osteotomy: Is There a Difference?

The Journal of Knee Surgery ◽

10.1055/s-0040-1721027 ◽

2020 ◽

Author(s):

Alexander Hoorntje ◽

P. Paul F. M. Kuijer ◽

Koen L. M. Koenraadt ◽

Suzanne Waterval-Witjes ◽

Gino M. M. J. Kerkhoffs ◽

...

Keyword(s):

High Tibial Osteotomy ◽

Outcome Measures ◽

Controlled Trial ◽

Return To Sport ◽

Secondary Outcome ◽

Tibial Osteotomy ◽

Level Of Evidence ◽

Cross Sectional ◽

Knee Oa

AbstractKnee joint distraction (KJD) is a novel technique for relatively young knee osteoarthritis (OA) patients. With KJD, an external distraction device creates temporary total absence of contact between cartilage surfaces, which results in pain relief and possibly limits the progression of knee OA. Recently, KJD showed similar clinical outcomes compared with high tibial osteotomy (HTO). Yet, no comparative data exist regarding return to sport (RTS) and return to work (RTW) after KJD. Therefore, our aim was to compare RTS and RTW between KJD and HTO. We performed a cross-sectional follow-up study in patients <65 years who previously participated in a randomized controlled trial comparing KJD and HTO. Out of 62 eligible patients, 55 patients responded and 51 completed the questionnaire (16 KJDs and 35 HTOs) at 5-year follow-up. The primary outcome measures were the percentages of RTS and RTW. Secondary outcome measures included time to RTS/RTW, and pre- and postoperative Tegner's (higher is more active), and Work Osteoarthritis or Joint-Replacement Questionnaire (WORQ) scores (higher is better work ability). Patients' baseline characteristics did not differ. Total 1 year after KJD, 79% returned to sport versus 80% after HTO (not significant [n.s.]). RTS <6 months was 73 and 75%, respectively (n.s.). RTW 1 year after KJD was 94 versus 97% after HTO (n.s.), and 91 versus 87% <6 months (n.s.). The median Tegner's score decreased from 5.0 to 3.5 after KJD, and from 5.0 to 3.0 after HTO (n.s.). The mean WORQ score improvement was higher after HTO (16 ± 16) than after KJD (6 ± 13; p = 0.04). Thus, no differences were found for sport and work participation between KJD and HTO in our small, though first ever, cohort. Overall, these findings may support further investigation into KJD as a possible joint-preserving option for challenging “young” knee OA patients. The level of evidence is III.

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Intra Articular Ozone Modulates Inflammation and Has Anabolic Effect on Knee Osteoarthritis: IL-6 and IGF-1 as Pro-Inflammatory and Anabolic Biomarkers

10.20944/preprints202111.0552.v1 ◽

2021 ◽

Author(s):

Marcos E. Fernández-Cuadros ◽

Olga S. Pérez-Moro ◽

María J Albaladejo-Florín ◽

Rubén Algarra-López ◽

María M. Tobar-Izquierdo ◽

...

Keyword(s):

Uric Acid ◽

Knee Osteoarthritis ◽

Real World ◽

Secondary Outcome ◽

Womac Pain ◽

Anabolic Effect ◽

Obese Patients ◽

Knee Oa ◽

Before And After ◽

Anti Inflammatory

Objectives: 1) to demonstrate the anti-inflammatory and anabolic effect of Ozone by determining in serum samples the biochemical levels of IL-6 and IGF-1 in knee osteoarthritis (OA) patients in a real world in Rehabilitation Setting; 2) to evaluate clinical effectiveness by Visual Analog Scale (VAS) and WOMAC scale, and biochemical effect by C-reactive protein (CRP), uric acid and erythrocyte sedimentation rate (ESR). Material and methods: 65 patients with knee OA Kellgren Lawrence (KL) grade 2 or more were analyzed in a retrospective observational study. The study run from January 2018 to September 2021. Inclusion criteria: a) patients 18 years or older; b) with knee OA KL 2º or more; c) biochemical analysis before-and-after treatment; d) pain more than 3 on VAS. Exclusion Criteria: a) previous knee surgery; b) favism; c) pregnancy; d) any other disease that originates lack of collaboration for infiltration. Primary Outcome variables: a) IL-6; b) IGF-1 in diabetes mellitus (DM)/obese and non-DM/non-obese patients; both before-and-after Ozone treatment. Secondary Outcome variables: a) CRP, b) ESR, c) uric acid, d) VAS pain, e) WOMAC pain, function and stiffness. Ozone protocol consisted of 4 sessions (once a week) of an intra-articular infiltration of 20 mL (20µg/mL concentration) of a gas mixture of Oxygen-Ozone 95-5% (produced by Ozone generator Ozonosan-α Plus ®). For biochemical evaluation, SNIBE MAGLUMI ™ IL-6 (CLIA) and SNIBE MAGLUMI ™ IGF-1 (CLIA) kits were used. CRP and uric acid were analyzed by Abbott Alinity c kit; and ESR was evaluated by DIESSE VES MATIC CUBE 30. Results: There is a linear correlation between age and OA severity. IL-6 decreased both in DM and non-DM patients and in all OA KL grades (from 2.7 to 1.59 pg/mL). IGF-1 decreased in total group (OA + DM + obesity) from 112.09 to 107.19 ng/mL. When only knee OA patients were analyzed, Ozone improved IGF-1 levels (from 100.17 to 102.03 ng/mL). Ozone decreased CRP, ESR, uric acid, and improved VAS pain, WOMAC pain, function and stiffness (p<0.05). Conclusions: Ozone is a valid option for the management of knee osteoarthritis in real world Rehabilitation Setting, because of its anti-inflammatory, metabolic and anabolic properties. Ozone downregulates pro-inflammatory IL-6 cytokine. Ozone has a metabolic/hypoglycemic effect on obese/diabetic knee osteoarthritis patients by reducing IGF-1. Ozone has an anabolic effect on non-diabetic/non-obese patients by improving IGF-1. Ozone reduces other biomarkers of inflammation (CRP, ESR and uric acid) and improves, pain, function and quality of life.

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