ACL InjuryNCT06635668
Baseline ACL Injury Risk Screening and Normative Data
An observational study of ACL Injury and Anterior Cruciate Ligament Injuries, run by Sanford Health at 1 site in United States.
Trial summary
This is a prospective, observational cohort study aimed at establishing a database of normative biomechanics for healthy athletes and surveying these athletes for 12 months following baseline testing for the occurrence of new musculoskeletal injuries, with a particular emphasis on ACL injuries. Read more about this study
- Who is it for?
- Ages 10 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury, Anterior Cruciate Ligament Injuries, Musculoskeletal Injury
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2022to 1 Jul 2033
- Phase
- Observational
- 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 10 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Community sampling.
Who may be able to join
- Healthy athletes participating in formal, organized, competitive sports between the ages of 10 and 65 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katie Jensen contact
United States1 site, 1 recruiting
- Recruiting
Sanford Health
Fargo, North Dakota, 58103
Colin Bond, PhD, MBA, 701-417-6170, colin.bond@sanfordhealth.org
About this study
This is a prospective, observational cohort study aimed at establishing a database of normative biomechanics for healthy athletes and surveying these athletes for 12 months following baseline testing for the occurrence of new musculoskeletal injuries, with a particular emphasis on ACL injuries.
Read the detailed description
This study is a prospective, observational cohort study aimed at establishing a database of normative biomechanics data for healthy athletes. The primary focus is on quantifying muscle strength, movement patterns, and biomechanics in relation to the risk of musculoskeletal injuries, particularly ACL injuries. The study will also explore the relationship between these biomechanical factors and the occurrence of new injuries over a 12 month follow-up period.
The research will involve a large sample size of athletes within the Sanford Health service area, including those participating in organized sports at middle schools, high schools, and universities. Advanced marker less three-dimensional motion capture technology will be employed to gather high-fidelity biomechanical data. This will allow for the development of sophisticated algorithms to assess individual injury risk and facilitate targeted interventions aimed at reducing the likelihood of ACL injuries.
Participants will undergo an injury risk screen, which is a standard component of the athletic camps sponsored by Sanford Sports and Sanford Orthopedics and Sports Medicine. This screen includes assessments of muscle strength and movement biomechanics, along with the collection of demographic and sports participation data. Participants will then receive a follow-up surveys at six and twelve months to report any new injuries.
The study is designed to provide essential normative data, which is currently lacking, particularly for tests used in the assessment of ACLR patients. This data will enhance clinicians' ability to evaluate a patient's readiness for return to sport by comparing their performance to robust normative values. Additionally, the study will collect data on other risk factors, such as a history of concussions, to better understand the interplay between these factors and biomechanics in ACL injury risk.
By establishing this comprehensive database, the study aims to improve patient care by informing ACL and ACLR treatment and return-to-play guidelines, ultimately reducing the risk of ACL re-injury in athletes.
- Keywords
- Athletes, Biomechanics
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of injury
The primary outcome measure will assess the incidence of ACL injuries among participants. This metric will be determined by responses to a follow-up survey administered at 6 and 12 months post-injury risk screen. Participants will be asked whether they sustained an injury that prevented them from participating in their sport or activity for 10 or more consecutive days. The measure will capture any new ACL injuries occurring within the specified follow-up period.
Measured: 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start19 Jul 2022
- Primary completion1 Jul 2032 (estimated)
- Study completion1 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colin Bond, PhD, MBA, Principal investigator, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635668
- Sponsor's protocol ID
- ACL- BUS
- Status last verified
- Apr 2026
- First submitted
- 8 Oct 2024
- Last updated
- 17 Apr 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline ACL Injury Risk Screening and Normative Data
- ClinicalTrials.gov ID
- NCT06635668
- Acronym / sponsor ID
- ACL- BUS
- Keywords
- Athletes, Biomechanics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 1 Jul 2032 (estimated)
- Study completion
- 1 Jul 2033 (estimated)
- First posted
- 10 Oct 2024 (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.
This is a prospective, observational cohort study aimed at establishing a database of normative biomechanics for healthy athletes and surveying these athletes for 12 months following baseline testing for the occurrence of new musculoskeletal injuries, with a particular emphasis on ACL injuries.
Detailed description
This study is a prospective, observational cohort study aimed at establishing a database of normative biomechanics data for healthy athletes. The primary focus is on quantifying muscle strength, movement patterns, and biomechanics in relation to the risk of musculoskeletal injuries, particularly ACL injuries. The study will also explore the relationship between these biomechanical factors and the occurrence of new injuries over a 12 month follow-up period.
The research will involve a large sample size of athletes within the Sanford Health service area, including those participating in organized sports at middle schools, high schools, and universities. Advanced marker less three-dimensional motion capture technology will be employed to gather high-fidelity biomechanical data. This will allow for the development of sophisticated algorithms to assess individual injury risk and facilitate targeted interventions aimed at reducing the likelihood of ACL injuries.
Participants will undergo an injury risk screen, which is a standard component of the athletic camps sponsored by Sanford Sports and Sanford Orthopedics and Sports Medicine. This screen includes assessments of muscle strength and movement biomechanics, along with the collection of demographic and sports participation data. Participants will then receive a follow-up surveys at six and twelve months to report any new injuries.
The study is designed to provide essential normative data, which is currently lacking, particularly for tests used in the assessment of ACLR patients. This data will enhance clinicians' ability to evaluate a patient's readiness for return to sport by comparing their performance to robust normative values. Additionally, the study will collect data on other risk factors, such as a history of concussions, to better understand the interplay between these factors and biomechanics in ACL injury risk.
By establishing this comprehensive database, the study aims to improve patient care by informing ACL and ACLR treatment and return-to-play guidelines, ultimately reducing the risk of ACL re-injury in athletes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community sampling.
Key inclusion criteria (1 listed)
- Healthy athletes participating in formal, organized, competitive sports between the ages of 10 and 65 years old
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of injury
Time frame: 12 months from baseline
The primary outcome measure will assess the incidence of ACL injuries among participants. This metric will be determined by responses to a follow-up survey administered at 6 and 12 months post-injury risk screen. Participants will be asked whether they sustained an injury that prevented them from participating in their sport or activity for 10 or more consecutive days. The measure will capture any new ACL injuries occurring within the specified follow-up period.
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 17 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for ACL Injury
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Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
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Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
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BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
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Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
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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.
Katie Jensen contact
Colin Bond, PhD, MBA principal investigator
Sanford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Injury and Anterior Cruciate Ligament Injuries, run by Sanford Health 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 1 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 17 Apr 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. 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?
Contact Colin Bond, PhD, MBA (701-417-6170, colin.bond@sanfordhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of injury (time frame: 12 months from baseline). 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 17 Apr 2026.