Injection Of Micro-fragmented Adipose Tissue Research Articles

ADIPOSE CELLULAR INJECTION IN THE TREATMENT OF AN INTRASUBSTANCE ACHILLES TENDON TEAR

Introduction: We describe a case report of a patient who presented with chronic right Achilles tendon pain and weakness. Without contrast, magnetic resonance imaging of the right Achilles tendon revealed significant expansion of the Achilles tendon in the traverse and anteroposterior dimension with extensive increased T2 signal consistent with large partial-thickness Achilles tendon tear. A musculoskeletal ultrasound using a linear transducer demonstrated an anechoic tendon defect measuring 0.97 cm in the longitudinal axis with a total tendon length measuring 1.53 cm, as well as a 0.9 cm defect in the transverse axis surrounded by homogenous tendon fibers consistent with a large defect involving the distal Achilles tendon proximal to the distal insertion. The patient underwent an ultrasound-guided adipose cellular procedure using micronized fat to fill in the defect and facilitate pain reduction and tissue healing.Conclusion: Ultrasound-guided injection of micro-fragmented adipose tissue of Achilles tendon defect can result in significant improvement in pain and function

MICRO-FRAGMENTED ADIPOSE TISSUE IN THE SUCCESSFUL TREATMENT OF RECURRENT ROTATOR CUFF TEARS IN AN INJURED WORKER

This is the case of a 42-year-old right-handed male truck cargo mechanic who suffered a rotator cuff (RTC) tear of his right shoulder after a slip and fall while at work. An MRI of the shoulder demonstrated supra-spinatus and infraspinatus tendon tears. After a trial of 4 months of nonoperative treatment, he underwent arthroscopic repair of his RTC. Postoperatively, he completed a course of physical therapy (PT) and a work conditioning program. Unfortunately, he had ongoing pain, limitations in range of motion (ROM), and functional limitations, which prevented him from returning to work. A repeat MRI demonstrated a retear of supraspinatus and infraspinatus tendons. After consulting with the author, he underwent a micro-fragmented adipose tissue injection under ultrasound guidance into the involved tendons. After 4 weeks of additional PT, he was noted to have full, pain-free ROM with normal strength and was able to return to his full work duties, including overhead lifting without restrictions.

In Patients with Symptomatic Knee Osteoarthritis, a Single Intra-Articular Injection of Microfragmented Adipose Tissue Did Not Differ from Platelet-Rich Plasma for Clinical Outcomes at Up to 24 Months.

1Department of Orthopaedic Surgery, Northwell Health, New York, NY Disclosure: The Disclosure of Potential Conflicts of Interest form is provided with the online version of the article (https://links.lww.com/JBJS/H453). Lipogems International.

Autologous micro-fragmented adipose tissue injection provides significant and prolonged clinical improvement in patients with knee osteoarthritis: a case-series study

PurposeAmong the conservative strategies to manage patients with symptomatic knee osteoarthritis (OA), an innovative approach exploiting the regenerative capability of adipose tissue and its resident MSCs (Mesenchymal Stem Cells or Medicinal Signalling Cells) has been proposed with encouraging results. This study aims to demonstrate the benefits of autologous micro-fragmented adipose tissue (MAT) injection in the conservative treatment of knee osteoarthritis and whether any variables may affect the outcome. This is a case series single-centre study in which patients underwent intraarticular MAT injection without any associated procedures.MethodsBased on inclusion and exclusion criteria, 49 patients (67 Knees) were included and retrospectively analysed with a mean follow-up of 34.04 ± 13.62 months (minimum 11 – maximum 59). Patients were assessed through the WOMAC and KOOS questionnaires at baseline (pre-treatment) and 1-, 3-, 6-, 12-, 24- and 36-month follow-up. A minimal clinically important difference (MCID) of at least 7.5 points for the WOMAC pain scale and 7.2 for the WOMAC function scale compared to the baseline value was used.ResultsWOMAC and KOOS scores improved after treatment compared to baseline at all follow-ups with p < 0.001. Male gender and Kellgren-Lawrence (KL) grade 2 were associated with smaller improvement in WOMAC and KOOS scores (with respect to females and to KL grade 1, respectively) up to 24 months. The percentage of patients who reach the MCID for WOMAC pain is generally lower than that of patients who reach the MCID for WOMAC function (around 80% at all time points), but it increases significantly over time. Moreover, the baseline score of the WOMAC pain and function influence the outcome. Patients with worse symptoms are more likely to reach the MCID.ConclusionsIntra-articular knee injection of MAT for the treatment of knee osteoarthritis (KOA), recalcitrant to traditional conservative treatments, proved to be effective in a high percentage of cases. The positive association between a worse pre-operative score and a better clinical response to the treatment would support the idea that intra-articular administration of MAT could be considered in patients with very symptomatic KOA in which joint-replacement surgeries are not indicated (or accepted).Level of EvidenceIV, case series.

An observational study evaluating the efficacy of microfragmented adipose tissue in the treatment of osteoarthritis.

Aim: Osteoarthritis(OA) prevalence is increased in ageing and obese populations. This prospective single-arm cohort study aimed to investigate the efficacy of autologous microfragmented adipose tissuetreatment of severe knee or shoulder OA. Materials & methods: Participants received an intra-articular microfragmented adipose tissue injection to the affected joint(s). Multiple patient reported outcome measures (PROMS) were recorded from 0 to 52weeks for 63 consecutive joints. Results: Compared with baseline, there were significant improvements in all PROMS from 2 to12weeks and maintained at 52weeks. Regression analysis revealed an inverse correlation with BMI and change in PROMS for knee joints. Conclusion: Our observed findings suggest this approach represents a safe, effective treatment for moderate-to-severe knee and shoulder OA, although efficacy may be reduced with increasing obesity.

Long Term Outcomes in Patients Receiving Microfragmented Adipose Tissue Injection for Treatment of Knee Osteoarthritis

Long Term Outcomes in Patients Receiving Microfragmented Adipose Tissue Injection for Treatment of Knee Osteoarthritis

Autologous micro-fragmented adipose tissue associated with arthroscopy in moderate–severe knee osteoarthritis: outcome at two year follow-up

BackgroundAdipose tissue has recently gained growing interest in the treatment of osteoarthritis (OA). The aim of the present study was to evaluate the efficacy of a single injection of autologous micro-fragmented adipose tissue (aMFAT) associated with arthroscopy (cartilage debridement/meniscal regularization or selective meniscectomy/micro-drilling) for symptomatic knee OA.MethodsThis retrospective, single-center study included 49 patients (50 knees) affected by knee OA (radiographic Kellgren-Lawrence III-IV) treated with a single injection of autologous micro-fragmented adipose tissue and knee arthroscopy. Knee Injury and Osteoarthritis Outcome Score (KOOS) and subjective International Knee Documentation Committee (IKDC) score were the primary outcome measures and were collected at one and 2 years post-operatively. Patients were divided into clusters based on age, complexity of arthroscopic procedures and chondral lesion grade.ResultsFour patients underwent knee replacement (8%). No major adverse events were reported. Minimal Clinically Important Difference (MCID) for KOOS and IKDC was reached by 84 and 74% of all cases at 1 year and by 80 and 76% at 2 years, respectively. High grade chondral lesions negatively affected the outcome at 2 years follow-up (p < 0.05 for IKDC, KOOS overall and 3 out of 5 subscales).ConclusionThe injection of micro-fragmented adipose tissue associated with arthroscopy demonstrated to be a safe and effective procedure for the treatment of knee OA, with a substantial improvement in IKDC and KOOS scores and without major complications.

Intraoperative injection of microfragmented adipose tissue during hip arthroscopy as immediate postoperative pain reliever: a retrospective study

article: Intraoperative injection of microfragmented adipose tissue during hip arthroscopy as immediate postoperative pain reliever: a retrospective study - Minerva Orthopedics 2022 October;73(5):458-63 - Minerva Medica - Journals

Effects of Intra-Articular Autologous Adipose Micrograft for the Treatment of Osteoarthritis in Dogs: A Prospective, Randomized, Controlled Study.

Simple SummaryOsteoarthritis (OA) is a very common musculoskeletal condition that affects dogs, as well as humans and other species, and causes pain, lameness, and disability. Since therapy is not always effective and is definitive only in some cases, OA is still a leading cause of euthanasia in dogs and a challenge for orthopedic surgeons. Recently, new therapeutic approaches, such as the use of autologous mesenchymal stem cells, have been developed. The purpose of this prospective, randomized, controlled, in vivo clinical study was to estimate the safety, feasibility, and efficacy of the intra-articular treatment of autologous microfragmented adipose tissue in dogs affected by spontaneous OA in comparison with a treatment with hyaluronic acid. Pain, lameness, the radiographic progression of OA, and synovial fluid inflammation were assessed. The results suggest that intra-articular injection of microfragmented autologous adipose tissue is safe, timesaving, cost-effective, minimally invasive, and can be easily done in one step. This treatment, compared with the hyaluronic acid treatment, showed better long-term pain control and an amelioration of synovial fluid quality, resulting in an improvement in joint function. This new treatment can be included among the effective therapies for OA. Additionally, the canine spontaneous OA model adopted in this study could play a key role in developing successful treatments for translational medicine.The purpose of this study was to estimate the safety, feasibility, and efficacy of the intra-articular treatment of autologous microfragmented adipose tissue in dogs with spontaneous osteoarthritis (OA) in comparison with hyaluronic acid (HA), the standard intra-articular treatment. Specifically, it clinically evaluated pain and lameness, the radiographic progression of osteoarthritis, and synovial fluid inflammation. This was a prospective, single-center, parallel-group, randomized, controlled, in vivo clinical study. Participants (n = 40) received either a single intra-articular injection of microfragmented adipose tissue or a single intra-articular injection of HA (1:1). Clinical outcomes were determined using a specialistic clinician assessment obtained by the completion of a specific clinical form based on the Vesseur modified lameness classification system, a pain evaluation using the Visual Analogue Scale (VAS), the measurement of the range of motion (ROM) of the affected joint, limb circumference, and the owners’ score evaluation using the Canine Brief Pain Inventory (CBPI) for up to 6 months after the time of injection. Patients underwent a radiographic examination to establish the degree of OA in the affected joint, and synovial fluid samples were collected to assess the biochemical environment of the joint and evaluate and quantify the cellular population and the presence of three specific inflammation biomarkers for up to 60 days. The results of this study suggest that microfragmented autologous adipose tissue is safe and can effectively relieve pain and improve function in dogs with spontaneous articular OA. This one-step procedure is simple, timesaving, cost-effective, minimally invasive, and eliminates the need for complex and time-intensive cell culture processing. Furthermore, the clinical evidence and cytological results suggest better long-term pain control, resulting in an improvement in joint function, compared to HA treatment. The canine spontaneous OA model could play a key role in developing successful treatments for human medicine.

Conversion to Knee Arthroplasty Following Intra-Articular Injection of Microfragmented Adipose Tissue in Patients with Knee Osteoarthritis

Conversion to Knee Arthroplasty Following Intra-Articular Injection of Microfragmented Adipose Tissue in Patients with Knee Osteoarthritis

Autologous Microfragmented Adipose Tissue for the Treatment of Knee Osteoarthritis: Real-World Data at Two Years Follow-Up.

The purpose of the present study was to assess, prospectively, the safety, clinical effectiveness, and feasibility of a single intra-articular injection of microfragmented adipose tissue in different stages of knee osteoarthritis (OA). The study included patients (aged 18–70 years), affected by OA (Kellgren–Lawrence I-IV). Unselected patients were evaluated before and prospectively after 6, 12, and 24 months from the injection. Visual analog scale (VAS) and knee injury and osteoarthritis outcome score (KOOS) were used for clinical evaluations. A total of 202 patients were eligible. The mean follow-up time in the cohort of patients was 24.5 ± 9.6 months. Total KOOS significantly improved from pre-operative baseline levels to 6-month follow-up (p < 0.001), and again between 6- and 12-month follow-ups (p < 0.001). The VAS showed a prompt reduction at 6 months (p < 0.001 vs. baseline), but then it increased again at 12 months compared to the 6-month assessment (p < 0.001), even though it remained lower than baseline (p < 0.001). At 24 months, patients with KL-IV demonstrated a lower improvement compared to baseline; patients that had undergone previous corticosteroid injections had a greater risk to further injection treatment. The collected clinical results suggest that MFAT may represent a safe and effective treatment for OA symptoms, offering a low-demanding and minimally invasive treatment.

Intraarticular injection of microfragmented adipose tissue plus arthroscopy in isolated primary patellofemoral osteoarthritis is clinically effective and not affected by age, BMI, or stage of osteoarthritis

PurposeThis study aimed to report the clinical and functional results of a series of patients with isolated primary patellofemoral osteoarthritis (PFOA) treated with intraarticular injection of microfragmented autologous adipose tissue plus knee arthroscopy. The results were also analyzed in relation to the age and body mas index (BMI) of patients, and to the stage of PFOA.MethodsTwenty-three patients with early-to-moderate (stage 1–3 according to the Iwano classification system) PFOA who received this treatment were retrospectively analyzed, with a mean follow-up of 22.1 ± 4.2 months. Patients were assessed using the International Knee Society (IKS) knee and function and visual analog scale (VAS) scores, and relative to their capacity for climbing stairs. Differences in improvements of IKS and VAS scores in relation to age (< 60 versus ≥ 60 years), BMI (< 30 versus ≥ 30 kg/m2), and stage of PFOA (stages 1–2 versus stage 3) were finally analyzed.ResultsThe mean IKS knee score significantly improved from 35.6 ± 14.9 points preoperatively to 61.9 ± 17.8 points at the latest follow-up, while the mean IKS function score significantly improved from 52.0 ± 14.7 points preoperatively to 82.3 ± 19.1 points at the latest follow-up. The mean VAS score significantly decreased from 8.7 ± 2.2 preoperatively to 5.2 ± 2.5 at the latest follow-up. A significant improvement in the capacity to climb stairs was found. No significant differences in improvements of IKS knee and function and VAS scores were found in relation to age, BMI, or stage of PFOA.ConclusionIntraarticular injection of microfragmented autologous adipose tissue following arthroscopic debridement significantly improved overall clinical and functional scores in patients with early or moderate isolated primary PFOA at a mean follow-up of almost 2 years. Improvements were not significantly affected by age, BMI, or stage of PFOA.Level of evidenceLevel IV, retrospective case series.

A new approach to regenerative medicine in gynecology.

To evaluate the efficacy of the injection of microfragmented adipose tissue in the treatment of women with genitourinary syndrome of menopause (GSM). This observational cohort study included 12 women who received one session of multiple injections of microfragmented adipose tissue using the SEFFIGYN™ medical device. Symptoms such as burning, itching, dryness, pain on penetration, pain during deep intercourse, and pain on urination were assessed before the patient's treatment (T0), after 15days (T15), and after 5months (5Mo) using the Numerical Rating Scale (NRS). An improvement of vulvar trophism was clinically evident already 2weeks after treatment; all symptoms were notably attenuated compared with the initial visit, as demonstrated by statistically significant reductions of the NRS scores (P=0.003 for itching, P=0.008 for pain on urination, and P<0.001 for the other symptoms, Sign test). Moreover, all symptoms continued to improve over time. All patients reported a positive change in their quality of life and a resumption of sexual life. The use of microfragmented adipose tissue in GSM is promising. Nevertheless, more studies will be fundamental to exclude a potential placebo effect and better understand the underlying molecular mechanism of action.

Microfragmented Adipose Tissue Injection (MFAT) May Be a Solution to the Rationing of Total Knee Replacement: A Prospective, Gender-Bias Mitigated, Reproducible Analysis at Two Years.

Background Knee osteoarthritis (KOA) is a significant cause of disability in a globally ageing population. Knee replacement surgery has been shown to improve function and quality of life. Access to this intervention can be limited for a number of reasons including rationing of care, lack of healthcare provision in austere environments, and more recently, due to the cessation of elective orthopaedic care as a result of the COVID pandemic. Referral for knee replacement surgery is often guided by the patient's Oxford Knee Score (OKS). Recent therapies including treatment with microfragmented adipose tissue (MFAT) have emerged as alternatives to relieve pain and improve function in such patients. Method We identified all patients with KOA Kellgren-Lawrence grade 3 and 4 in our dataset of patients treated with a single injection of MFAT and applied published OKS thresholds for referral for TKR to separate them into 3 cohorts according to their functional impairment. 220 patients (95 females, 125 males) with KOA were given one MFAT injection. The function (OKS) and quality of life (EuroQol-5) prior to and 24 months after therapy were compared. Results MFAT injection provided a statistically significant improvement in the quality of life (EQ-5D) at 24 months in patients with a baseline OKS of 39 or less (p value: <0.001) as well as those with OKS of 27 or less who are deemed suitable for a knee replacement (p value: <0.001). Conclusion MFAT injection improves quality of life in patients with KOA who are deemed suitable for the knee replacement. MFAT is a low-morbidity alternative biological treatment and can delay the need for total knee replacement in suitable patients.

12-Month Cohort Study to Investigate Changes in Patient-Reported Outcomes Pain after Intra-articular Injection of Micro-Fragmented Adipose Tissue for Knee Osteoarthritis

BackgroundTo evaluate changes in pain, function, and quality of life after treatment with injected micro-fragmented adipose tissue (MFAT) for knee osteoarthritis in a large cohort of individuals treated at multiple centers. MethodsOne hundred ten individuals were recruited from three private outpatient clinics. Participants had to be diagnosed with symptomatic knee OA (defined by persistent knee pain associated with clinical symptoms of OA and/ or classic imaging findings) and who had not received prior knee surgery or treatment with platelet-rich plasma, cortisone, or hyaluronic acid within the previous 6 weeks. Data from 120 knees were included in the analysis. Outcome measures included Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales (pain, symptoms, activities of daily living [ADL], sports and recreation, quality of life [QOL]) and an 11-point Numerical Rating Scale (NRS) for average knee pain over the past week. Outcomes were collected at baseline and 3, 6, and 12 months. ResultsSignificant increases and decreases in KOOS subscale and NRS scores were observed, respectively, in the cohort as a whole (p&lt; .05). Lower BMI was associated with more significant improvements in pain, sports/recreation, and ADL KOOS subscale scores (p&lt; .05). Greater age was associated with more significant improvements in symptoms and QOL subscale scores (p&lt; .05). ConclusionsA single injection of MFAT improved pain, function, and QOL outcome measures up to 12 months in this cohort for more than half of the participants. Greater BMI and lower age negatively influenced outcomes. It is not known whether improvements continue after this timeframe or why many participants reported little-to-no improvement.

A pilot study to evaluate micro-fragmented adipose tissue injection under ultrasound guidance for the treatment of refractory rotator cuff disease in wheelchair users with spinal cord injury

Context/Objectives Wheelchair users with chronic shoulder pain have few options after conservative treatments fail. This pilot study’s purpose was to establish safety and treatment effects of micro-fragmented adipose tissue (MFAT) injections under ultrasound guidance for treatment of refractory shoulder pain caused by rotator cuff disease in wheelchair users with spinal cord injury (SCI) to prepare for a larger trial. Design Pilot clinical trial. Setting Rehabilitation hospital outpatient clinic. Participants Ten wheelchair users with chronic SCI who had moderate-to-severe shoulder pain caused by refractory rotator cuff disease (diagnosed via ultrasound) for greater than 6 months. Interventions Ultrasound-guided injections of MFAT into the pathologic rotator cuff tendons and other abnormal shoulder structures (e.g. acromioclavicular and glenohumeral joints; subacromial bursa). Outcome Measures 6- and 12-month changes in 11-point Numerical Rating Scale (NRS); Wheelchair User’s Shoulder Pain Index (WUSPI); Brief Pain Inventory pain interference items (BPI-I7); Patient Global Impression of Change (PGIC); ultrasound and physical exams; and adverse events. Conclusions There were no significant adverse events throughout the study period. WUSPI, NRS, and BPI-I7 scores were significantly lower 6 and 12 months post-procedure (P < .05). Of those who remained in the trial, clinically meaningful changes (≥30% decrease) in WUSPI, NRS, and BPI-I7 scores were observed in 77.8%, 77.8%, and 66.7% of participants, respectively. All but one participant reported improvement in clinical status. MFAT injection under ultrasound guidance is potentially a safe and efficacious treatment for refractory shoulder pain caused by rotator cuff disease in wheelchair users with SCI. A larger, randomized controlled trial has been initiated. Trial registration: ClinicalTrials.gov identifier: NCT03167138

Temporomandibular Joint Arthrocentesis and Microfragmented Adipose Tissue Injection for the Treatment of Internal Derangement and Osteoarthritis: A Randomized Clinical Trial

Purpose Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis. Microfragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint. The purpose of this randomized clinical trial is to compare standard treatment conducted by injecting hyaluronic acid after the procedure to the new treatment relying upon microfragmented adipose tissue injection using the Lipogems technology. Materials and Methods A randomized clinical trial was designed enrolling 20 patients in the control group receiving the standard treatment and 20 patients in the experimental group receiving microfragmented adipose tissue obtained through the Lipogems technology after arthrocentesis. Two main outcomes were defined, pain (visual analogic scale) and function (maximum interincisal opening). Both were measured in the immediate preoperative time, and 10 days, 1 month, and 6 months after the procedure. Results In both groups, pain reduction and mouth opening significantly improved compared with the preoperative situation (P = .001). At 6-month follow-up, there was an almost statistically significant reduction of pain compared with preoperative visual analogic scale (P = .0546) and a statistically significant improvement of mouth opening (P = .0327). Overall, statistical analyses showed that the experimental group had a statistically significant superiority in the success rate of the procedure compared with the control group (P = .018). Conclusions Preliminary results of this clinical trial show that the injection of microfragmented adipose tissue can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic. Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function. Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis. Microfragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint. The purpose of this randomized clinical trial is to compare standard treatment conducted by injecting hyaluronic acid after the procedure to the new treatment relying upon microfragmented adipose tissue injection using the Lipogems technology. A randomized clinical trial was designed enrolling 20 patients in the control group receiving the standard treatment and 20 patients in the experimental group receiving microfragmented adipose tissue obtained through the Lipogems technology after arthrocentesis. Two main outcomes were defined, pain (visual analogic scale) and function (maximum interincisal opening). Both were measured in the immediate preoperative time, and 10 days, 1 month, and 6 months after the procedure. In both groups, pain reduction and mouth opening significantly improved compared with the preoperative situation (P = .001). At 6-month follow-up, there was an almost statistically significant reduction of pain compared with preoperative visual analogic scale (P = .0546) and a statistically significant improvement of mouth opening (P = .0327). Overall, statistical analyses showed that the experimental group had a statistically significant superiority in the success rate of the procedure compared with the control group (P = .018). Preliminary results of this clinical trial show that the injection of microfragmented adipose tissue can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic. Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function.

Preliminary Study on the Echo-Assisted Intersphincteric Autologous Microfragmented Adipose Tissue Injection to Control Fecal Incontinence in Children Operated for Anorectal Malformations.

Aim of the study: To assess the efficacy of a novel technique (echo-assisted intersphincteric autologous microfragmented adipose tissue injection, also called “anal-lipofilling”) in the management of non-responsive fecal incontinence in children born with anorectal malformations (ARMs). Methods: Following ethical committee approval (CHPED-MAR-18-02), anal-lipofilling was proposed to patients with fecal incontinence not responsive to medications or bowel management (bowel enema and/or transanal irrigation automatic systems), then a prospective study was conducted. Anal-lipofilling consisted of three phases: lipoaspiration from the abdominal wall, processing of the lipoaspirate with a Lipogems system and intersphincteric injection of the processed fat tissue via endosonographic assistance. A questionnaire based on Krickenbeck’s scale (KS) was administered to the patients to evaluate the clinical outcome. Main Results: Four male patients (three recto-urethral fistula, and one recto-perineal fistula) underwent the anal-lipofilling procedure at a mean age of 13.0 ± 4.2 yrs. There were no complications during or after the procedure. From an initial assessment of the patients there was an improvement in the bowel function at a median follow up of 6 months, with better scores at KS (100% Soiling grade three pre-treatment vs. 75% grade one post-treatment). Conclusions: Even if our Study is preliminary, echo-assisted anal-lipofilling could be considered as a feasible and safe alternative technique in the management of the fecal incontinence in non-responding ARMs patients. More studies are still necessary to support the validity of the implant of autologous adipose tissue in the anal sphincter as a therapy for fecal incontinence in children born with ARMs.

Clinical evaluation of micro-fragmented adipose tissue as a treatment option for patients with meniscus tears with osteoarthritis: a prospective pilot study

PurposeThe management of knee pain secondary to meniscal tears with osteoarthritis is limited by the poor inherent healing potential of the meniscus. Previous studies have reported on the benefit of autologous micro-fragmented fat as a therapeutic for various knee pathologies. The goal of this prospective pilot study was to determine the safety and potential treatment effect of micro-fragmented adipose tissue injection for patients with knee pain secondary to osteoarthritis and meniscal tears who have failed conservative management.MethodsTwenty subjects with knee pain secondary to osteoarthritis with associated meniscal tear after failed conservative management were enrolled in the study. Numeric Pain Scale (NPS) and Knee Injury and Osteoarthritis Outcome Scale (KOOS) following ultrasound-guided intra-meniscal and intra-articular micro-fragmented adipose tissue injections were examined at three, six and 12 months.ResultsThe mean NPS revealed a significant decrease in patient pain at the 1-year time point compared with baseline (5.45 to 2.21, p < .001). Similarly, overall, mean KOOS symptoms significantly improved from 57.7 to 78.2 (p < .001), with all 4 KOOS subscales demonstrating significant improvement at the final one year follow-up. One subject developed uncomplicated cellulitis at the harvest site which was treated with oral antibiotics. Other complications were minor and mostly limited to adipose harvest.ConclusionThis study demonstrated that micro-fragmented adipose tissue injected directly into a torn meniscus and knee joint using ultrasound guidance represents a safe and potentially efficacious treatment option for patients with knee pain suffering from degenerative arthritis and degenerative meniscal tears. A larger, randomized, controlled trial is warranted to determine efficacy.Trial registrationClinicaltrials.org Identifier: NCT03714659

Treatment of fistula-in-ano: Outcome comparison between traditional surgery and novel approaches. A retrospective cohort study in a single center

Aim: Fistula-in-ano is a well described disease but no definitive surgical technique has been developed. We conducted a retrospective cohort study in a single center to evaluate patients who underwent surgical treatment of a perianal fistula from 2012 to 2018 in our hospital. The aim of the study was to compare the outcome of different surgical techniques (Fistulotomy/fistulectomy and seton, Video-Assisted Anal Fistula Treatment (VAAFT), Micro-fragmented adipose tissue injection, Lipogems®).Methods: A cohort of 103 patients with anal fistula who qualified for elective surgery between 2012 and 2018 were recruited at Sant’Anna Hospital in Ferrara. All patients underwent a digital rectal examination and preoperative magnetic resonance imaging (MRI) to identify the fistula tract and internal opening. Patients were divided into 4 groups, one for each type of surgery they underwent: Fistulotomy/fistulectomy and seton, Video-Assisted Anal Fistula Treatment (VAAFT), Micro-fragmented adipose tissue injection, Lipogems®). Numerical rating scale (NRS) was used to assess subjective pain one week after surgery and documented. The scale ranged from 0 to 10, where 0 stands for no pain and 10 stands for worst pain ever faced. Primary end point was fistula recurrence at 1 year of follow-up. Secondary end point was evaluation of post-operative pain. Results: There were 71 males and 32 females, with a median age of 50 years (range 21-89 years). Among them, 79 patients were newly diagnosed, the other 24 patients had undergone previous surgery and had recurrence. In total, 118 surgical operation were performed for anal fistula. During the follow-up period, anal fistula recurrence was observed in 13 patients after VAAFT, 3 patients after Micro-fragmented adipose tissue injection, 4 after fistulotomy, 12 after fistulectomy, 10 after seton placement and 8 after Lipogems® technique. One week after surgery, pain was evaluated by all patients on a scale from 0 to 10. The mean scores of patients who underwent VAAFT, micro-fragmented adipose tissue injection, fistulotomy, fistulectomy, seton placement and Lipogems® technique were 1 (0-5), 1.5 (0-8), 5 (3-8), 6.8 (5-9), 4.2 (2-6) and 0 (0-2), respectively. Conclusion: This study presents the difficulties in managing anal fistulas and the variety of surgical options. VAAFT and Micro-fragmented adipose tissue injection appear to be safe and feasible options in the management of anal fistula, and short-term healing rates are acceptable with no sustained effect on continence. There is, however, a paucity of robust data with long-term outcomes. These techniques are thus welcome additions. Lipogems ® technique is a safe and reproducible procedure, unfortunately according to our experience, it does not promote fistula healing in patients with recurrent inter-sphincteric anal fistula. We do not suggest the use of this technique as a first-line treatment.