Clinical trial NCT06635668: Baseline ACL Injury Risk Screening and Normative Data
Official title: Baseline ACL Injury Risk Screening and Normative Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ACL Injury
Anterior Cruciate Ligament Injuries
Musculoskeletal Injury
Keywords: Athletes
Biomechanics
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 5000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sampling.

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 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.

Eligibility criteria: Inclusion Criteria:

* Healthy athletes participating in formal, organized, competitive sports between the ages of 10 and 65 years old

Exclusion Criteria:

* Athletes who are injured at the time of consent and pregnant individuals

Primary outcomes:
measure: Incidence of injury
timeFrame: 6 and 12 months from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Sanford Health
state: North Dakota
Study officials:
affiliation: Sanford Health
name: Colin Bond, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: