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The purpose of this research project is to assess the effectiveness of intra-articular injections of autologous platelet-rich plasma (PRP) after arthroscopic microfracture. Our hypothesis is that platelet-rich plasma will improve patient's clinical outcomes and chondral healing following microfracture performed during femoroacetabular impingement (FAI) hip arthroscopy.
The purpose of this research project is to assess the effectiveness of intra-articular injections of autologous platelet-rich plasma (PRP) after arthroscopic microfracture. Our hypothesis is that platelet-rich plasma will improve patient's clinical outcomes and chondral healing following microfracture performed during femoroacetabular impingement (FAI) hip arthroscopy.
This study has two aims:
Microfracture has shown good results with chondral lesions of the hip. However, microfracture does not regenerate normal hyaline cartilage. There is growing evidence that PRP can improve articular cartilage healing. Injection of PRP following microfracture may help regeneration to normal hyaline like articular cartilage together with soft tissue healing, thereby improving patients' early and long-term outcomes of chondral healing.
Patients will be randomized to one of two study arms - microfracture with PRP (treatment arm) and microfracture with saline (control arm) in a 1:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-rich plasma (PRP) | Experimental | Intra-articular injections in the hip of autologous platelet-rich plasma (PRP) at week 1 and 2 post-operatively. Dose 5 mL. PRP is derived from the patient's own blood. |
|
| Saline | Placebo Comparator | Intra-articular injections in the hip of saline, solution week 1 and 2 post-operatively. Dose: 5 mL at each injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-rich plasma (PRP) | Biological |
|
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| Measure | Description | Time Frame |
|---|---|---|
| MRI dGEMRIC | MRI dGEMRIC will be utilized to assess chondral healing. Change is being assessed between measurement time points. | 12 and 24 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| PA Hip X-Ray | Change is being assessed between measurement time points. | Baseline, 12 and 24 months post-operative |
| International Hip Outcome Tool (IHOT) | Patient reported outcomes assessed from patient completed surveys. Change is being assessed between measurement time points. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecilia Pascual-Garrido, M.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver, CU Sports Medicine | Boulder | Colorado | 80304 | United States |
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| ID | Term |
|---|---|
| D057925 | Femoracetabular Impingement |
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug |
|
|
| Pre-operative; and 3, 6, 12, and 24 month post-operative |
| Western Ontario and McMaster (WOMAC) osteoarthritis index | Patient reported outcomes assessed with patient completed survey.Change is being assessed between measurement time points. | Pre-operative; and 3, 6, 12, and 24 month post-operative |
| Non-arthritic hip score | Patient reported outcomes assessed with patient completed survey. Change is being assessed between measurement time points. | Pre-operative; and 3, 6, 12, and 24 month post-operative |
| Range of Motion (ROM) | ROM assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points. | Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative |
| Flexion Abduction and External Rotation (FABER) | FABER assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points. | Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative |
| Bicycle Kicks | Bicycle kicks assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points. | Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D017670 |
| Sodium Compounds |