Anterior Cruciate Ligament InjuriesNCT07580157
A Study Of Focused Shockwave For Anterior Knee Pain Following Anterior Cruciate Ligament Reconstruction
A study testing Focused Shockwave in people with Anterior Cruciate Ligament Injuries, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Focused Shockwave
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Focused Shockwave For Anterior Knee Pain Following Anterior Cruciate Ligament Reconstruction (ACL-R)
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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Focused Shockwave, Sham Focused Shockwave
- Keywords
- Focused Shockwave, Bone-patellar tendon-bone autograft, Quadriceps tendon autograft
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Focused shockwave | Experimental | Focused shockwave (FSW) will be applied to the autograft harvest site for 3 consecutive weekly sessions. Receives: 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. Receives: Other: Sham Focused Shockwave |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months
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.
Measured: 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.
Measured: Baseline, 7 days, 14 days, 21 days, 6 months, 9 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Aug 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua M. Romero, Mayo Clinic
- Investigators
- Joshua M. Romero, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580157
- Sponsor's protocol ID
- 26-001203
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Shockwave For Anterior Knee Pain Following Anterior Cruciate Ligament Reconstruction (ACL-R)
- ClinicalTrials.gov ID
- NCT07580157
- Acronym / sponsor ID
- 26-001203
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- Focused Shockwave, Bone-patellar tendon-bone autograft, Quadriceps tendon autograft
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focused shockwave | Experimental | Other: Focused ShockwaveFocused shockwave (FSW) will be applied to the autograft harvest site for 3 consecutive weekly sessions. |
| Sham focused shockwave | Sham comparator | Other: Sham Focused ShockwaveThe sham focused shockwave will be applied to the autograft harvest site for 3 consecutive weekly sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused ShockwaveFocused 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 | Focused shockwave |
| Sham Focused ShockwaveThe 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. | Other | Sham focused shockwave |
Primary outcome
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
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua M. Romero, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Shockwave in people with Anterior Cruciate Ligament Injuries, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.