Sanford Health
Fargo, North Dakota, 58103, United States
Location status: Recruiting
NCT Number: NCT06635668
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.
Interested in participating?
Request Info10 year–65 year
All sexes
Observational
Fargo, North Dakota, 58103, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Contact information is provided by the study sponsor or research team.
Sanford Health
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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