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slow enrollment, lack of patients
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP | Experimental |
| |
| Whole Blood | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP | Biological |
| ||
| Whole Blood |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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". | Up to 1 year post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Up to 1 year post-injection |
| Pain During Side-lying Hip Abduction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Moley, M.D. | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Platelet-rich Plasma | PRP Ultrasound |
| FG001 | Whole Blood | Whole Blood |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Platelet-rich Plasma | PRP Ultrasound |
| BG001 | Whole Blood | Whole Blood |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This study was terminated early, and data collection could not be completed. Thus, no data were analyzed. | Posted | Up to 1 year post-injection |
|
|
This study was terminated early. Adverse event data were not collected to completion for each of the patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Platelet-rich Plasma | PRP Ultrasound | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Cheng | Hospital for Special Surgery | 6467146870 | chengj@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 6, 2018 | Aug 6, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 6, 2018 | Aug 6, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Ultrasound | Device |
|
Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".
| 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". | Up to 1 year post-injection |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
| Primary | Improvement in Function | The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function. | This study was terminated early, and data collection could not be completed. Thus, no data were analyzed. | Posted | Up to 1 year post-injection |
|
|
| Primary | Patient Satisfaction | The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from "very dissatisfied" to "extremely satisfied". | This study was terminated early, and data collection could not be completed. Thus, no data were analyzed. | Posted | Up to 1 year post-injection |
|
|
| Secondary | 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". | This study was terminated early, and data collection could not be completed. Thus, no data were analyzed. | Posted | Up to 1 year post-injection |
|
|
| Secondary | 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". | This study was terminated early, and data collection could not be completed. Thus, no data were analyzed. | Posted | Up to 1 year post-injection |
|
|
| Secondary | 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". | This study was terminated early, and data collection could not be completed. Thus, no data were analyzed. | Posted | Up to 1 year post-injection |
|
|
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Whole Blood | Whole Blood | 0 | 1 | 0 | 1 | 0 | 1 |
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