None listed
Conditions
Brief summary
This is a parallel randomised controlled trial comparing operative versus nonoperative management for recalcitrant greater trochanteric pain syndrome (GTPS). While the majority of cases of GTPS improve significantly or resolve with nonoperative management, there is no evidence that compares operative to nonoperative management when the condition is deemed recalcitrant (after 6 months of symptoms). We are looking to investigate the natural history of the condition (what occurs when no treatment is given over a period of time). To do this, we are comparing nonoperative management consisting only of advice to continue your normal daily life with surgical treatment for the condition. Current surgical standard of care for recalcitrant GTPS consists of endoscopic iliotibial band release and trochanteric bursectomy. The study aims to investigate whether surgical intervention leads to reduced pain and improved function compared with continued nonoperative management in the treatment of recalcitrant greater trochanteric pain syndrome. This study will be conducted as a randomised controlled trial with the control arm receiving advice to continue along their daily life for the period of the trial. The intervention arm will receive the current surgical standard of care, consisting of endoscopic iliotibial band release and trochanteric bursectomy. Our hypothesis is there will be an improvement in the pain and function in the intervention group receiving the surgery compared to the control group. We are hoping this will result in a change in standard practice for this group of patients, whereby patients with severe recalcitrant GTPS symptoms undergo an appropriate intervention for their pain. At the end of the trial, any patients with ongoing pain despite the continued non-operative treatment will be offered the surgical treatment if they desire.
Interventions
Intervention group: Will receive the surgical standard of care for greater trochanteric pain syndrome, consisting of endoscopic iliotibial band release and trochanteric bursectomy
This will be performed under general anaesthesia by the principal investigator, a consultant orthopaedic surgeon and will take approximately 30 minutes. There is no need to monitor adherence to this intervention.
Sponsors
Western Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients (age >18yrs) GTPS diagnosed clinically by the principal investigator (according to following criteria – must have 1 & 2, as well as one of 3-5): 1. History of aching pain on lateral aspect of hip 2. Distinct tenderness about the greater trochanter 3. Pain at extremes of hip rotation 4. Pain on strong contraction of hip abductors 5. Pseudoradiculopathy (pain radiating down lateral thigh) Have had minimum 6 months of symptoms Failed minimum of 6 months of non-operative treatment for their symptoms (rest/physiotherapy/corticosteroid injection) Have had minimum one previous corticosteroid injection into area of affected hip (not intra-articular) Have optimised non-operative management (e.g. on appropriate analgesics, have medical comorbidities well controlled) Have an ultrasound or MRI scan showing signs of GTPS (gluteal tendinopathy, bursitis) without a full thickness gluteal muscle or tendon tear Have had hip x-ray prior to intervention showing no or mild arthritis (Tonnis grade 0 or 1) Have no clinical signs of other pathology not related to GTPS that can cause lateral hip/thigh or groin pain on their affected side
Exclusion criteria
Any previous surgery on affected hip (e.g. arthroscopy, total hip replacement) Other pathology involving affected hip region that can mimic pain of GTPS, for example: Moderate to severe hip arthritis (Tonnis grade 2-3) Labral tear Femoroacetabular impingement Lumbar radiculopathy Hip dysplasia Fibromyalgia Full thickness gluteal muscle tear on affected side (diagnosed clinically and on US/MRI) Does not speak English Unable to complete questionnaires due to mental/physical comorbidities Person is known to have a psychological, developmental, physical, emotional or social disorder that may interfere with compliance with study requirements
Outcome results
None listed