None listed
Conditions
Brief summary
Tendons and Tendinopathy Tendons are the tough fibrous bands of tissue that connect our muscles to bony prominences on the human skeleton. They are extremely strong and allow muscles to work to allow movement and stability of the human body. Tendinopathy is degeneration of healthy tendons and is sometimes called tendonitis or tendinosis. It is usually caused by microtears within the tendon and a decrease in tendon repair cells. GTPS and Gluteal tendinopathy Greater trochanteric pain syndrome (GTPS) is a common condition that typically affects females in the 40-60 year age bracket. Patients complain of pain felt over the outer aspect of the hip. The condition was previously labelled trochanteric bursitis however modern imaging techniques and better understanding has revealed that a common cause of GTPS is tendinopathy or tears of the gluteal tendons around the hip. The reported incidence is 1.8 patients per 1000 per year. Current treatments Currently, initial treatments centre around non-steroidal anti-inflamatory drugs, physical therapy and weight loss. The next stage of treatment is often corticosteroid injections into the gluteal bursa. These may be targeted under xray control, or blind. Steroid injections often give short term relief of symptoms, for 6 to 12 weeks but relapse of symptoms is common. At present, common treatment methods have proven relatively ineffective. Tendinopathy Tendinopathy is also common in other areas of the body such as the achilles tendon, patella tendon, rotator cuff and tendons around the elbow that give rise to tennis elbow. Studies have shown that the process in these diseased tendons is similar. There are micro-tears in and around the tendon that lead to a decrease in tendon repair cells. Given that examination of tendinopathic tendons has revealed cell death there has been recent interest in developing cell technology to potentially aid repair and regeneration. The precursors to tendon cells can be harvested from normal tendons and grown in a laboratory. They can then be injected into diseased tendons. Preliminary animal studies have shown that this treatment can improve tendon remodelling, collagen content and tensile strength. Clinical pilot trials in human tendons for lateral epicondylitis (tennis elbow) have demonstrated safety and efficacy of the techninque, as well improved clinical and radiological outcomes. At present, there is a clinical trial being conducted into the injection of autologous tenocytes for achilles tendinopathy. (http://clinicaltrials.gov/ct2/show/NCT01343836) ATI therapy Autologous tenocyte implantation (ATI) is a new tissue engineering technique that involves an initial biopsy of healthy tendon cells. This is usually taken from the patella tendon. A very small piece of tendon is taken with a needle and then the cells within are cultured and grown over a period of 5-6 weeks in the Orthocell laboratory. The cells are then injected back into the injured tendon under ultrasound guidance. This delivers around 2 million tenocyte cells directly to the area of degenerate tendon. Given the promising work in animal studies and clinical studies in human tendons, we propose a pilot study to investigate the use of ATI in gluteal tendinopathy.
Interventions
Autologous tenocyte implantation is a two stage process: The ATI Tendon Biopsy The tendon biopsy is performed by a consultant radiologist. Under local anaesthetic and with suitable aseptic precautions a small piece of patella tendon will be harvested with a trucut needle. The biopsy is very small and will not cause significant problems to the integrity of the patella tendon. The biopsy will be placed in carrier medium and transported to the Orthocell facility. Orthocell has licencensed authorisation for the manufacture, storage and release for supple of Autologous Tenocytes by the Australian Therapeutic Goods Administration within the Department of Health and Aging. The tenocytes are cultured for 5-6 weeks. A vial of cultured tenocytes contains 2 million cultured cells. Autologous Tenocyte Implantation The second stage of treatment is implantation. This will also be performed at Perth Radiological Clinic by a Consultant radiologist. An ultrasound probe will be used to locate the diseased area of gluteal tendons. A needle will then be placed under ultrasound control into the tendon, and the tenocytes injected. This is an outpatient procedure and therefore the patient will go home the same day. Both procedures are performed just once and there are no current plans for repeat treatments
Sponsors
Study design
Eligibility
Inclusion criteria
Gluteal tendinopathy, with or without partial tears. Failure of normal conservative treatments
Exclusion criteria
Previous surgery Full thickness gluteal tendon tears Hip osteoarthritis Active infection