NCT07580157Enrolling By InvitationNot Applicable
Focused Shockwave For Anterior Knee Pain Following Anterior Cruciate Ligament Reconstruction (ACL-R)
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Mayo Clinic
- Enrollment
- 20
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Focused shockwave
Experimental
Focused shockwave (FSW) will be applied to the autograft harvest site for 3 consecutive weekly sessions.
Intervention: Focused Shockwave (Other)
Sham focused shockwave
Sham Comparator
The sham focused shockwave will be applied to the autograft harvest site for 3 consecutive weekly sessions.
Intervention: Sham Focused Shockwave (Other)
Investigators
Joshua M. Romero
Principal Investigator
Mayo Clinic
Study Sites (1)
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