None listed
Conditions
Brief summary
Over the past two decades, obesity has morbidly increased in an alarming rate in the Gulf countries among adults and children. According to the World Health Organization (WHO), Kuwait, Bahrain, Saudi Arabia and United Arab Emirates are in the list of top ten countries worldwide in terms of obesity (ALNohair, 2014). Moreover, obesity is considered one of the greatest modifiable risk factor for OA. Obesity is strongly correlated with the incidence and progression of OA of both weight bearing and non-weight bearing joints. It increases the load of the weight-bearing joint, which may be the most important mechanical contribution. Therefore, over-weight can significantly improve the pain level and function of the knees for obese people with OA (King, March, & Anandacoomarasamy, 2013). Articular cartilage forms the bearing surfaces of all synovial joints. Human articular cartilage has a very limited repair potential which has always imposed a great challenge to orthopedic surgeons. Replacement by metal prostheses is reserved as a last resort given the finite durability of prostheses as well as the increasing life span and activity levels of the general population. While the outcomes of joint replacement for degenerative joint disease are often favorable, an increased incidence of prosthesis failure over time limits the use of this treatment modality for younger patients -especially highly active ones- for whom a desirable treatment would be the resurfacing of the joint with a biological tissue. 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 have been proposed (autologous graft, micro-fractures, physical stimulation, biomaterials, etc.) with variable success rates. Therefore, the availability of a minimally manipulated, autologous adipose tissue would have remarkable biomedical and clinical relevance. The proposed procedure is gentle and intra-operatively provides micro-fragmented adipose tissue in a short time (15-20 minutes), without expansion and/or enzymatic treatment, very rich in mature pericytes and which has been shown to be effective in the treatment of different pathologies. In this study, the aim of this study is to test if autologous, micro-fragmented and minimally manipulated adipose tissue can provide support and/or significant decrease pain in people with osteoarthritis of the knees.
Interventions
This procedure will be performed at the minor operation theatre at Aspire Medical Center – Kingdom of Bahrain. Each participant will have his or her own sterile kit that will be used and disposed after the completion of the procedure. Surgical items and instrument is not to be re-used for another procedure. The kit is sterile and the procedure is performed under aseptic technique.
One intravenous cannula will be inserted for the pre-operative analgesia and antibiotic then connected to a normal
This procedure will be performed at the minor operation theatre at Aspire Medical Center – Kingdom of Bahrain. Each participant will have his or her own sterile kit that will be used and disposed after the completion of the procedure. Surgical items and instrument is not to be re-used for another procedure. The kit is sterile and the procedure is performed under aseptic technique. One intravenous cannula will be inserted for the pre-operative analgesia and antibiotic then connected to a normal saline bag to keep the vein open. Thirty minutes before the procedure, a 1g of intravenous Paracetamol and 1g of Ceftriaxone- prophylactic dose of antibiotic intravenously administered to the participant. During the procedure, only local anesthesia is needed and it will be injected only in the participant’s abdomen- the lipo harvesting site. The participant will be fully awake and aware of what is happening during the procedure while being connected to a nasal cannula for two to four liters of oxygen and monitored via a pulse oximetry. The orthopedic consultant (the principal investigator (PI)) will perform the procedure solely with the assistance of one scrub nurse and one circulating nurse. In case of any difficulties in lipoaspiration, such as in a case of a very thin participant, a certified plastic surgeon will perform the lipoaspiration only and the remaining steps of the procedure from tissue handling, processing, and intra-articular knee injection will be completed by the PI. The participant will be lying supine on the theatre bed. They will be exposed from the xiphisternum up to the line drawn between the two anterior superior iliac spines. The harvest site of the procedure is the abdomen. The procedure will take place at both sides of the abdomen. The area will be scrubbed twice with Betadine- an antiseptic solution, and then dried with sterile gauze. Draping of the area will be done using sterile surgical sheets exposing only the area for liposuction. Procedure steps: STEP 1 - Harvesting of the adipose tissue The lower or the lateral abdomen will be chosen as donor site for adipose tissue harvesting. Before harvesting the fat, the site will be injected with Klein solution (1 vial adrenaline + 50 cc lidocaine 2% in 500 cc saline) using a disposable 17G blunt cannula connected to a luer-lock 60-cc syringe. The fat (50 cc) will be then harvested using a 13G blunt cannula, for a fast and a-traumatic suction, connected to a Vaclock"Registered Trademark" 20-ml syringe. STEP 2 - Processing of the adipose tissue with Lipogems"Registered Trademark" device The harvested fat will be immediately processed in the Lipogems"Registered Trademark" processing kit, a disposable device that progressively reduces the size of the adipose tissue clusters while eliminating oily substances and blood residues with pro-inflammatory properties. The entire process, carried out in one surgical step, will be performed in complete immersion in physiological solution minimizing any trauma to the cells. The resulting micro-fragmented fat will be collected in a 60-cc syringe and positioned for decanting the excess saline solution. The resulting product will be then transferred into several 1-cc syringes to be injected in the patient. STEP 3 - Injection in the joint Micro-fragmented fat (8-10 cc) will be injected to the supralateral angle of patella of each knee. At the end of the procedure, only first aid bandage will be applied to the injection site.
Sponsors
Aspire Medical Center
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Participant agreeing and able to give informed consent. 2. Symptomatic osteoarthritis of the knee (Grades II and III based on Kellgren and Lawrence system). 3. Age between 18 and 70 years. 4. Participants with body mass index (BMI) up to 35 kg/m2. 5. Failure of conservative treatments for at least 6 months. 6. No surgery for the same indication within 12 months prior to treatment.
Exclusion criteria
1. Participants younger than 18 years and older than 70 years. 2. Participants with BMI more than 35 kg/m2. 3. Participants whom underwent bilateral total knee replacement. 4. Bedridden patients. 5. Knee osteoarthritis with the following conditions: complex ligamentous knee joint instability, skeletal immaturity, and osteochondral tumor. 6. Axial malalignment (> 10/15 degrees of varus or valgus). 7. Existing infection in or around the joint. 8. Patients with inflammatory joint disease, autoimmune disease. 9. Patients allergic to Paracetamol. 10. Patients with contraindication to MRI. 11. Vulnerable population (pregnant women, prisoners, military, homeless, elderly, mentally disordered patients, emergency patients).
Outcome results
None listed