None listed
Conditions
Brief summary
This is a parallel randomised controlled trial analysing the effect of adding a singular intra-operative platelet-rich plasma (PRP) injection into the gluteus medius tendon to current surgical standard of care consisting of endoscopic iliotibial band release and trochanteric bursectomy for recalcitrant greater trochanteric pain syndrome (GTPS). The singular PRP injection will be administered at the time of surgery while the patient is anaesthetised. The study aims to investigate whether adding PRP injection to surgery confers any additional reduction in pain and improvement in function compared to surgery alone. This study will be conducted as a randomised controlled trial with the control arm receiving the current surgical standard of care, consisting of endoscopic iliotibial band release and trochanteric bursectomy, without PRP. The experimental arm will receive the same surgical intervention but with an additional single PRP injection into the gluteus medius tendon. Our hypothesis is there will be an improvement in the experimental group with the addition of PRP. We are hoping this will result in a change in standard practice for this group of patients, whereby patients who undergo this operation receive PRP concurrently.
Interventions
Arm 1: Surgical release of iliotibial band and excision of trochanteric bursa (control)
Arm 2: Surgical release of iliotibial band and excision of trochanteric bursa with single intraoperative injection of platelet-rich plasma into gluteus medius musculotendinous junction
The procedure is performed with the patient lying on their unaffected side. If the patient is to receive PRP, 55ml of blood is extracted from a patient's vein while they are anaesthetised and spun down using a device to gain
Arm 1: Surgical release of iliotibial band and excision of trochanteric bursa (control) Arm 2: Surgical release of iliotibial band and excision of trochanteric bursa with single intraoperative injection of platelet-rich plasma into gluteus medius musculotendinous junction The procedure is performed with the patient lying on their unaffected side. If the patient is to receive PRP, 55ml of blood is extracted from a patient's vein while they are anaesthetised and spun down using a device to gain 6ml of platelet-rich plasma which is injected immediately after the surgical intervention is complete, via the endoscopic portals. The procedure involves a longitudinal split of the ITB and excision of the bursa and take approximately 30 minutes.
Sponsors
Western Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult > 18yrs old Greater trochanteric pain syndrome (GTPS) diagnosed clinically by principal investigator according to following criteria (must have number 1+2 and 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 down thigh Have had minimum 6 months of symptoms Failed minimum of 6 months of non-operative management (including rest, physiotherapy and corticosteroid injection) Undergone minimum of 1 previous corticosteroid injection into area about greater trochanter Have optimised medical management (control of medical comorbidities, on appropriate analgesics as required) Have ultrasound or MRI showing signs of GTPS (gluteal tendinopathy and/or bursitis) without a full thickness gluteal muscle or tendon tear Have hip X-ray showing no or mild arthritis (Tonnis grade 0 or 1)
Exclusion criteria
Any previous surgery on affected hip (e.g. arthroscopy, total hip replacement) Previous platelet-rich plasma (PRP) injection into affected hip region Other pathology involving affected hip that can mimic pain of GTPS (e.g. hip arthritis grade 2-3, labral tear, femoroacetabular impingement, ligamentum teres tear, lumbar radiculopathy, hip dysplasia, fibromyalgia Full thickness gluteal muscle/tendon tear on affected side 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 Conditions where PRP is contraindicated and patient will be excluded: 1. History of severe uncontrolled diabetes mellitus 2. Platelet abnormality or platelet count < 100 x 109 /L 3. Haematological disorder 4. Serum haemoglobin < 11 g/dL 5. Use of systemic cortisone 6. Use of any anticoagulant 7. Evidence of gangrene/ulcers or peripheral vascular disease 8. History of hepatic or renal impairment or dialysis 9. History of alcohol or drug abuse 10. Person has a religious or cultural conflict with the use of platelet gel treatment or blood products 11. Has inadequate venous access for blood draw 12. Is currently receiving or has received radiation or chemotherapy within the last 3 months prior to the study 13. Pregnant women, or women who are lactating or planning pregnancy during the course of the study
Outcome results
None listed