None listed
Conditions
Brief summary
Gluteal tendinopathy is a degenerative condition of the hip. A recent randomized control trial showed that a single injection of platelet-rich plasma was associated with improvement of gluteal tendinopathy. This study will aim to assess whether imaging changes can be identified in the study population. The aim is to assess whether single LR-PRP or corticosteroid injection for gluteal tendinopathy results in improvement in gluteal tendon appearance on MRI at 2 years post intervention. The primary outcome measure will be statistically significant improvement in tendon imaging abnormalities on 2 year follow up MRI compared to pre-treatment MRI. MRIs will be reviewed and graded by an experienced radiologist. Gluteal tendon changes will be graded based upon a previously published gluteal tendinopathy MRI grading score. A secondary outcome measure will be statistically significant correlation with clinical improvement as described in the original randomised control trial by Fitzpatrick et al . This will be a single-centre trial conducted as a follow up of a double-blind randomised control trial. The subjects will be all subjects from the double-blind randomised control trial that weren’t lost to follow up along with those who were in the open labelled extension to the trial who had a pre-study MRI. An experienced radiologist will assess pre and post LR-PRP RCT MRI using a validated grading system. The radiologist will be blinded to the identity of the patient and to which post-trial MRI relates to which pre-trial MRI. Once the imaging has been scored statistical analysis will be used to determine whether the changes are significant. They will also be compared to the clinical changes seen in the randomised control trial to assess any statistical correlation in the two measures.
Interventions
This study will aim to answer the question of whether single LR-PRP injection for gluteal tendinopathy results in long term radiological improvement in imaging abnormalities to the tendons.
This will be a single-centre trial conducted as a follow up of a double-blind randomised control trial.
The subjects will be drawn from the double-blind randomised control trial along with those who were in the open labelled extension to the trial, who had a pre-study MRI.
Participants will be asked to give
This study will aim to answer the question of whether single LR-PRP injection for gluteal tendinopathy results in long term radiological improvement in imaging abnormalities to the tendons. This will be a single-centre trial conducted as a follow up of a double-blind randomised control trial. The subjects will be drawn from the double-blind randomised control trial along with those who were in the open labelled extension to the trial, who had a pre-study MRI. Participants will be asked to give consent for researchers to access pre and post-treatment MRI scans. For those who have not had a post-treatment MRI, they will be asked to have an MRI scan performed. There will be no requirement for participants to attend for visits (other than to have an MRI if needed). A radiologist will assess pre and post treatments MRI scans using a grading system. The radiologist will be blinded to the identity of the patient and to which post-trial MRI relates to which pre-trial MRI. Once the imaging has been scored statistical analysis will be used to determine whether the changes are significant. This is anticipated to be completed over a 9 month period.
Sponsors
A/Prof Jane Fitzpatrick
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All subjects from the initial LR-PRP or CSI arms of the double-blind randomised control trial that weren’t lost to follow up along with those who were in the open labelled extension to the trial who had a pre-study MRI.
Exclusion criteria
Subjects who did not have a pre-study MRI in the RCT
Outcome results
None listed