Micro-fragmented adipose tissue injection associated with arthroscopic procedures in patients with symptomatic knee osteoarthritis

G. Cattaneo1* , A. De Caro1, F. Napoli1, D. Chiapale2, P. Trada2 and A. Camera1

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Background: The social impact of degenerative diseases is steadily increasing, because of the continued rise in the mean age of the active population. Articular cartilage lesions are generally associated with disability and symptoms such as joint pain and reduced function, and remain a challenge for the orthopaedic surgeon. Several non-invasive solution have been proposed, but the results achieved to date are far from being completely satisfactory. Recently, new therapeutic approaches, such as the use of mesenchymal stem cells, have been developed. Among the many sources, the adipose tissue is nowadays considered one of the smartest, due to its abundance and easy access. The aim of this retrospective study is to explore whether patients affected by symptomatic knee osteoarthritis treated with micro-fragmented adipose tissue associated with a chondral shaving procedure experience an improvement in symptoms and function.

Methods: Thirty-eight patients affected by symptomatic knee osteoarthritis were treated in 2015 with an arthroscopic procedure associated with an injection of autologous and micro-fragmented adipose tissue. Micro-fragmented adipose tissue was obtained using a minimal manipulation technique in a closed system. Clinical outcomes were determined at 1, 3, 6, and 12 months follow-up using Knee Injury and Osteoarthritis Outcome Score questionnaire and direct physical examination. Safety of the procedure, recording type and incidence of any adverse event, was also assessed.

Results: A steady and statistically significant improvement of all the clinical scores from pre-operative evaluation to 1, 3, 6, and 12 months follow-up was observed, with KOOS sport and quality of life being the most improved scores. On average, 92% of the patients clinically improved and 100% of them were satisfied with the treatment. No adverse events nor relevant complications were recorded.

Conclusion: The result of the study pointed to micro-fragmented adipose tissue as a safe and beneficial adjuvant in the surgical treatment of degenerative knee chondropathy. The procedure is simple, sustainable, quick, minimally invasive, one-step, and safe. After one year, the results are very satisfactory and promising. A longer follow-up is needed to draw definitive conclusions and enlarge the indications.

Trial registration: Registered at clinicaltrials.gov as NCT03527693 on 27 April 2018 (retrospectively registered).


Non-Responding Knee Pain with Osteoarthritis, Meniscus and Ligament Tears Treated with Ultrasound Guided Autologous, Micro-Fragmented and Minimally Manipulated Adipose Tissue

Richard David Striano, Valeria Battista, Norma Bilboo

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Background: Chronic knee pain from advanced osteoarthritis is often associated with tears in the fibro-cartilaginous meniscus and cruciate ligaments. The result is substantial pain and impairments and loss of daily function, thus limiting activity and quality of life. These often include pain, loss of range of 116 motion, inability to elevate the leg, pain increased with activity and gradual worsening over time. This represents a challenging clinical picture for which few non-surgical options are available. Most patients failing to respond to current methods of care are offered arthroplasty. Current therapies are focused on the relief of the symptoms but cannot repair the damage nor stop the degenerative process.

Objective: This is a case study of the first subject in a continuing IRB to reach a 2.5 year end-point. Our intention was to investigate the potential benefits of using autologous, minimally manipulated fat graft in subjects with advanced osteoarthritis and meniscus pathology who had failed to obtain benefit from previous, standards of care.

Study description: 73 YO male, end stage bone-on-bone right knee pain. First subject to reach the 2 1/2 year follow up after Lipogems® precision ultrasound guided injections.

Material and Methods: Micro-fragmented fat was obtained using a minimal manipulation technology in a closed system, Lipogems®, without the addition of enzymes or other additives. Fat graft was injected under continuous ultrasound guidance.

Results: VAS pain, KOOS function, range of motion and quadriceps strength improved after treatment.

Conclusion: Autologous, micronized, and minimally manipulated adipose tissue resulted in significant improvement in pain, function and quality of life. No adverse events were reported.

Non-Responsive Knee Pain with Osteoarthritis and Concurrent Meniscal Disease Treated With Autologous Micro-Fragmented Adipose Tissue Under Continuous Ultrasound Guidance

R.D. Striano, H. Chen, N. Bilbool, K. Azatullah, J. Hilado, K. Horan

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Background: Adipose tissue has gained increased interest in the medical and scientific community over the last few years as a source for ortho-biologic therapies. It is readily accessible and simple to harvest. Adipose can be used to provide cushioning and filling of structural defects and has been shown to have an abundance of bioactive elements and regenerative perivascular cells.

Objectives: To evaluate the potential benefits of injecting a severely arthritic knee with concurrent meniscal disease with micro-fragmented non-digested adipose tissue using a novel technique by obtaining minimally manipulated and micronized fat tissue with intact stromal vascular niches harboring regenerative cellular elements. The case is non-responsive knee pain with osteoarthritis and concurrent meniscal disease.

Case Description: This case is the first of a 100- subject IRB study approved by IRCM. The patient is a 59-year-old male with severe knee pain who has failed a multitude of treatments, including arthroscopic meniscal surgery. The MRI prior to surgery revealed evidence of osteoarthritis, medial meniscal tear, and chondromalacia patella. The patient was followed for 6 months, and will continue to be followed for two years.

Materials and Methods: Micro-fragmented fat was obtained by using a minimal manipulation technique in a closed system (Lipogems®), without the addition of enzymes or any other additives. The final product consisted of micronized fat tissue yielding fat clusters with preserved vascular stroma of about 500 microns with intact stromal vascular niches and harboring regenerative cellular elements. In this treatment protocol, the micronized fat was injected with a 22- gauge needle under continuous ultrasound guidance into the joint and filling the hypoechoic defects in the medial meniscus. No other biological or pharmacological agents were used in combination with the micronized fat. Outcomes were measured immediately following the treatment, 24 hours, 1 week, 5 weeks, 3 months, 6 months and 1 year after the injections. At 6 months, a repeat MRI of the joint was performed.

Results: One year after the treatment, we found improvement in all measured scores. VAS pain score on a 1-10 scale, with 10 being worse, improved from 8 to 0; the KOOS (Knee Injury and Osteoarthritis Score) outcome, with a score of 100 being perfect, improved from 45 to 92.9. MRIs taken at 6 months post-treatment, revealed improved signal and thickness of the cartilaginous tissue over the medial femoral condyle, with a widened joint space. Radiologist initial measure of articular cartilage reported as 0.75 mm and at 6 months reported as 1.5 mm.

Conclusion: The injection of autologous microfragmented adipose tissue obtained with the new technique, Lipogems® in the case of non-responsive knee pain appears to be a promising and viable treatment. Due to the arthroscopic surgery taking place following the original MRI and prior to the treatment with micronized fat, the change in the meniscus after 6 months is not comparable. Further studies are underway.

Injection of autologous micro-fragmented adipose tissue for the treatment of post-traumatic degenerative lesion of knee cartilage: a case report

M. Franceschini, C. Castellaneta, G. Mineo

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Background: The chondral lesion of the knee represents a challenge for the orthopedic surgeon because of the limited regenerative properties of the affected tissue. A variety of treatments has been proposed with variable success rates. Recently, new therapeutic approaches, such as the use of mesenchymal stem cells (MSCs), seem to have promising results when applied in the context of joint degeneration, and an ideal source could be the adipose tissue, due to its abundance, the easy access, and the simple isolation procedures.

Objective: To evaluate the potential benefits of injecting autologous, micro-fragmented, and minimally manipulated adipose tissue (Lipogems®) in a severe case of a multi-operated cartilage degeneration.

Case description: The patient is a 33 years-old man, semi-professional snowboarder, with a knee trauma due to a ski fall who has failed a number of treatments. The patient was injected with Lipogems® and followed up for 30 months.

Patients and Methods: Micro-fragmented adipose tissue was obtained using a minimal manipulation technique in a closed system (Lipogems®), without the addition of enzymes or any other additives.

Results: After a first period of worsening of pain, symptoms got progressively better, and the pain completely disappeared in 6 weeks. The Oxford Knee Score at 12 weeks improved from 36 (baseline) to 46. The clinical improvement was confirmed by the MRI at 12 months. Thirty months after Lipogems® treatment the patient was able to ski with no pain and no restrictions.

Conclusion: Although this is a single case report, our results suggest that the autologous, micro-fragmented and minimally manipulated adipose tissue injected in a joint affected by a chondral lesion provides support and potential healing, improves joint functionality and determines pain relief.