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The purpose of this study is to investigate whether Focused Shockwave (FSW) therapy reduces anterior knee pain following anterior cruciate ligament reconstruction (ACL-R) with bone-patellar tendon-bone (BTB) or quadriceps tendon (QT) autografts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focused shockwave | Experimental | Focused shockwave (FSW) will be applied to the autograft harvest site for 3 consecutive weekly sessions. |
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| Sham focused shockwave | Sham Comparator | The sham focused shockwave will be applied to the autograft harvest site for 3 consecutive weekly sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focused Shockwave | Other | Focused shockwave will be administered to the autograft harvest site following anterior cruciate ligament reconstruction (ACL-R) using either bone-patellar tendon-bone (BTB) or quadriceps tendon (QT) autografts |
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score | The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation is a patient-reported outcome measure focusing on knee symptoms, function, and sports activity. It is scored on a 0-100 scale, where higher scores indicate higher function and lower symptoms. | Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in The Kujala Anterior Knee Pain Scale (AKPS) score | The Kujala Score or Anterior Knee Pain Scale (AKPS) is a 13-item a patient-reported questionnaire that assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome. The AKPS is graded on a scale of 0 to 100, with higher scores indicating better function and less pain. | Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or breastfeeding.
Revision ACL-R.
History of previous ipsilateral knee surgery.
Multi-ligament knee injury requiring surgical intervention beyond ACL.
o Not including concomitant meniscal or chondral injuries addressed at the time of surgery.
History of deep vein thrombosis.
Active infection at or near the harvest site.
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| Name | Affiliation | Role |
|---|---|---|
| Joshua M. Romero, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Sham Focused Shockwave | Other | The applicator tip will be placed on the skin with sterile gel and an audio recording of the focused shockwave will be turned on to mimic the sound of the machine. |
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| Tegner activity scale score | The Tegner Activity Scale (TAS) is a 2 item patient-reported questionnaire. Questions are answered with 0-10 rating system, used to standardize the measurement of work and sporting activity levels. Subjects select the highest activity level they can perform, where 0 represents disability and 10 represents national elite competitive sports. | Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months |
| Change in Visual Analog Scale (VAS) pain score | The Visual Analog Scale (VAS) is a 1-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 10, lower scores indicating lower pain and higher scores indicating greater pain. | Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months |