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Recruiting NCT06635668

Baseline ACL Injury Risk Screening and Normative Data

Observational ACL Injury Anterior Cruciate Ligament Injuries Musculoskeletal Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: ACL Injury, Anterior Cruciate Ligament Injuries, Musculoskeletal Injury. Basic parameters: 10 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Incidence of injury [Time frame: 12 months from baseline]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Sanford Health — Fargo

Identifiers

NCT: NCT06635668 · ACL- BUS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗