A Phase 4 interventional study of PRP and Whole Blood in Tendinopathy and Hip Pain, sponsored by Hospital for Special Surgery, New York. Terminated at 1 site in United States. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by Hospital for Special Surgery, New York · Phase 4, Interventional, and Treatment
Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by side lying, stair climbing, and walking. Treatment is currently limited to lifestyle modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical repair. Platelet rich plasma (PRP) injections contain important growth factors that are essential in the healing and tissue formation processes. However, the extent to which PRP is more efficacious than whole blood in tendinopathy remains unclear. In this double-blind randomized trial, patients will be allocated to receive either a PRP or whole-blood injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months, and 1 year.
413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.
This study's enrollment of 2 is below the median of 50 across 339 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: PRP · Device: Ultrasound
Biological: Whole Blood
Improvement in Pain
The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.
Time frame: Up to 1 year post-injection
Improvement in Function
The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.
Time frame: Up to 1 year post-injection
Patient Satisfaction
The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from "very dissatisfied" to "extremely satisfied".
Time frame: Up to 1 year post-injection
Quality of Movement During the Forward Step-down Test
The quality of movement will be assessed on a scale of 0-4+, where 4+="good", 2-3="moderate", and 0-1="poor".
Time frame: Up to 1 year post-injection
Pain During Side-lying Hip Abduction
Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".
Time frame: Up to 1 year post-injection
Pain During Forward Step-down Test
Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".
Time frame: Up to 1 year post-injection
| Milestone | Platelet-rich Plasma | Whole Blood |
|---|---|---|
| Started | 1 | 1 |
| Completed | 0 | 0 |
| Not completed | 1 | 1 |
| Withdrew: Study terminated | 1 | 1 |
The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.
No measurements were reported for this outcome.
The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.
No measurements were reported for this outcome.
The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from "very dissatisfied" to "extremely satisfied".
No measurements were reported for this outcome.
The quality of movement will be assessed on a scale of 0-4+, where 4+="good", 2-3="moderate", and 0-1="poor".
No measurements were reported for this outcome.
Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".
No measurements were reported for this outcome.
Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".
No measurements were reported for this outcome.
Collected over This study was terminated early. Adverse event data were not collected to completion for each of the patients.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Platelet-rich Plasma | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Whole Blood | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Platelet-rich Plasma | Whole Blood | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Platelet-rich Plasma | Whole Blood | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Platelet-rich Plasma | Whole Blood | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Platelet-rich Plasma | Whole Blood | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
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Hospital for Special Surgery, New York