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Enrolling by invitation NCT07580157

A Study Of Focused Shockwave For Anterior Knee Pain Following Anterior Cruciate Ligament Reconstruction

No phase Interventional Anterior Cruciate Ligament Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Focused Shockwave, Sham Focused Shockwave.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Injuries. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Focused Shockwave For Anterior Knee Pain Following Anterior Cruciate Ligament Reconstruction (ACL-R)

Overview

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

  • Other Focused 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
  • Other Sham 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.

Primary outcome measures

  • Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score [Time frame: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months]
Secondary outcome measures (3)
  • Change in The Kujala Anterior Knee Pain Scale (AKPS) score [Time frame: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months]
  • Tegner activity scale score [Time frame: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months]
  • Change in Visual Analog Scale (VAS) pain score [Time frame: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07580157 · 26-001203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗