None listed
Conditions
Brief summary
Background and study aims The hip joint has two bones that fit together like a ball in a socket. In some people these bones press against each other and can cause pain called "femororacetabular impingement" (FAI). Parts of the hip called the 'labrum' and 'cartilage' cushion the hip joint and allow the smooth friction-free movement. FAI can injure both the labrum and cartilage and also cause pain. There is good evidence to suggest a link between FAI and the development of premature osteoarthritis of the hip, but we do not know the best treatment for FAI. There has been a rapid increase in the use of keyhole surgery to treat this condition called 'hip arthroscopy'. During hip arthroscopy the patient is put to sleep and the surgeon passes a small telescope and tools into the hip joint through small cuts in the skin. The tools are used to reshape bone around the hip to prevent further impingement. Many patients have already undergone surgery and had improvements in pain and hip function in the short to medium term. However, this research was not compared to conventional care and it is possible that they may have similar levels of improvement without an operation. An alternative treatment option for patients is a course of best conventional care (a structured programme of exercise-based care supervised by a physiotherapist - this has been called personalised hip therapy) aimed at improving the muscle strength and control around the hip joint. There are fewer risks associated with this type of treatment and it is less expensive. We therefore propose a study to find out which of these two treatments is most effective for treating patients with FAI up to 12 months after treatment. Who can participate? The study aims to recruit 140 patients in Australia with hip pain, aged 16 and above. What does the study involve? Patients are randomly allocated to either undergo arthroscopic surgery or receive usual care. Participants will receive their allocated treatment and will then be required to complete some questionnaires at baseline, 6 and 12 months. Participants will be asked about further procedures required for their hip condition at 2 and 3 years following recruitment. At 12 months we will conduct our first analysis to measure the effectiveness of the two treatments. Australian FASHIon study participants will have specialised MRI scans using a contrast agent (gadolinium) used to investigate changes in the hip joint cartilage health. We will ask participants to have these scans when they join the study and after 12 months. Participants at the Melbourne study centres will be asked to attend the gait laboratory at the University of Melbourne where hip range of motion, muscle strength and movement patterns will be assessed. These measures will be taken at baseline and 12 months. An addition subset of 20 participants will be asked to perform some functional tasks with fine wires inserted in their muscles to provide information about their muscle activity.
Interventions
140 participants will be recruited from sites in Australia. Participation will be over a 3-year period. Participants will be allocated to either:
1. Hip Arthroscopic Surgery - performed by an experienced trained surgeon will involve viewing and treatment of the hip joint through a minimally invasive arthroscope inserted into the hip joint. Detailed guidelines for acetabular rim trimming, labral repair, labral resection, chondroplasty, microfracture and osteochondroplasty of the femoral head-neck
140 participants will be recruited from sites in Australia. Participation will be over a 3-year period. Participants will be allocated to either: 1. Hip Arthroscopic Surgery - performed by an experienced trained surgeon will involve viewing and treatment of the hip joint through a minimally invasive arthroscope inserted into the hip joint. Detailed guidelines for acetabular rim trimming, labral repair, labral resection, chondroplasty, microfracture and osteochondroplasty of the femoral head-neck junction will be followed by all surgeons consistent with the FASHIoN trial protocol. This procedure takes approximately 1.5- 2 hours Pre-operative: Patients will undergo routine preoperative care, including an anaesthetic consult assessing fitness for surgery and general anaesthesia. Peri-operative: Arthroscopic hip surgery will be performed under general anaesthesia in a lateral or supine position. Arthroscopic portals will be established in the central and peripheral compartment under radiographic guidance according to the surgeon’s usual practice. Shape abnormalities and consequent labral and cartilage pathology will be treated. Bony resection at the acetabular rim and at the head-neck junction will be assessed by intraoperative image intensifier radiograph and/or satisfactory impingement free range of movement of the hip. Osteo-integrative anchors will be used during the surgical procedure to avoid any issues with post-op MRI quality and dGEMRIC accuracy. Post-operative: Patients will be allowed home when they can walk safely with crutches (usually within 24h hours). On discharge all patients will be referred to outpatient physiotherapy services for a course of rehabilitation as per usual care for that surgeon. We will not specify a protocol for the duration, mode and format of this post-operative physiotherapy. These post-operative physiotherapists will be distinct from those providing PHT to avoid contamination between groups. Patients will also have a post-op MRI done at 12 months. 2. Best Conservative Care - a package of physiotherapy-led therapy entitled 'Personalised Hip Therapy' given over a 12-week period with an option of booster sessions up to 6 months.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: 16 years or over (no upper age limit) 2. Symptoms of hip pain - patients may also have symptoms of clicking, catching or giving way 3. Radiographic signs, demonstrated on cross sectional imaging following a plain radiograph, of either: * Cam morphology: Defined as an alpha angle over 55 degrees and/or * Pincer morphology: Defined as a lateral centre edge angle over 40 degrees or other radiographic signs of pincer; including positive cross over sign 4. The treating surgeon believes the patient would benefit from arthroscopic FAI surgery 5. The patient is able to give written informed consent and to participate fully in the interventions and follow-up procedures
Exclusion criteria
1. Evidence of pre-existing osteoarthritis, defined as Tonnis grade >1, or more than 2 mm loss of superior joint space width on AP pelvic radiograph 2. Previous significant hip pathology such as Perthes' disease, slipped upper femoral epiphysis, or avascular necrosis 3. Previous hip injury such as acetabular fracture, hip dislocation or femoral neck fracture 4. Previous shape changing surgery (open or arthroscopic) in the hip being considered for treatment 5. Renal impairment precluding use of contrast injection with MRI 6. Pregnant or breast-feeding patients
Outcome results
None listed