Anterior Cruciate Ligament Injuries
Conditions
Keywords
Focused Shockwave, Bone-patellar tendon-bone autograft, Quadriceps tendon autograft
Brief summary
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.
Interventions
OTHERFocused Shockwave
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
OTHERSham Focused Shockwave
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults ≥18 years of age. * Have undergone primary ACL-R with BTB or QT autograft. * Have not previously undergone FSW or radial pressure wave (RPW) in the past for any indication * Must speak English * Capacity to provide consent
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score | Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in The Kujala Anterior Knee Pain Scale (AKPS) score | Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months | 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. |
| Tegner activity scale score | Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months | 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. |
| Change in Visual Analog Scale (VAS) pain score | Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoshua M. Romero, M.D.
Mayo Clinic
Outcome results
None listed