NCT07580157

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
17mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 26, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 12, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

April 23, 2026

Last Update Submit

May 6, 2026

Conditions

Anterior Cruciate Ligament Injuries

Keywords

Focused ShockwaveBone-patellar tendon-bone autograftQuadriceps tendon autograft

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change in The Kujala Anterior Knee Pain Scale (AKPS) score

    Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months

  • Tegner activity scale score

    Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months

  • Change in Visual Analog Scale (VAS) pain score

    Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months

Study Arms (2)

Focused shockwave

EXPERIMENTAL

Focused shockwave (FSW) will be applied to the autograft harvest site for 3 consecutive weekly sessions.

Other: Focused Shockwave

Sham focused shockwave

SHAM COMPARATOR

The sham focused shockwave will be applied to the autograft harvest site for 3 consecutive weekly sessions.

Other: Sham Focused Shockwave

Interventions

Focused ShockwaveOTHER

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

Focused shockwave
Sham Focused ShockwaveOTHER

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.

Sham focused shockwave

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Joshua M. Romero, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2026

First Posted

May 12, 2026

Study Start (Estimated)

June 26, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 12, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)