Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
Study NCT ID:
NCT04231357
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2020-01-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Greater Trochanteric Pain Syndrome: Efficacy of Ultrasound Guided Platelet-rich Plasma vs Needle Tenotomy.
Sponsor:
Isabel Andia
Organization:
Study Overview
Official Title:
Great Trochanteric Pain Syndrome: Parallel Group, Blind Randomised Clinical Trial to Assess the Efficacy and Safety of PRP Injection Versus Needle Tenotomy With Lidocaine
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRP-GTPS
Brief Summary:
Great trochanteric pain syndrome (GTPS) is a difficult problem to manage and results in significant patient morbidity. This study is a single-center, randomized double-blind controlled trial. Eighty patients will be allocated to have an ultrasound (US)-guided injection of pure platelet-rich plasma (PRP) or needle tenotomy. Outcome data will be collected before the intervention, and at 3, 6, and 12 months after intervention. Main outcome measure: percent of patients that experience a reduction of 25% in hip outcome score (HOS) (responders) at 6 months after the intervention. Secondary outcome measures include percent of responders at three and twelve months, and pain reduction (VAS) at 3, 6, and 12 months. Adverse reactions or events will be recorded.
Detailed Description:
Evaluation of gluteal tendon pathology, including superoposterior and lateral aspects of gluteus medius and gluteus minimus(changes in echotexture, partial tears, calcified deposits, thickness, and loss of fibrillar pattern were evaluated by ultrasound at baseline, six and 12 m post-treatment. Peritrochanteric pathology including tensor fascia lata, trochanteric bursa, and cortical irregularities were also recorded. To analyze the relationship between the possible predictor variables (including sociodemographic and clinical factors, and imaging biomarkers, such as tendon degeneration and abnormalities in the peritrochanteric space) and changes in pain (VAS score) and functionality (HOS score), multivariate analyses were performed using multiple linear regressions.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-000538-21 | EUDRACT_NUMBER | None | View |