Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635668
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Baseline ACL Injury Risk Screening and Normative Data
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Baseline ACL Injury Risk Screening and Normative Data
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective observational cohort study aimed at establishing a database of normative biomechanics for healthy athletes and surveying these athletes for one year 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 one-year 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 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 patients 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
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 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None