NCT06635668

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 12 months following baseline testing for the occurrence of new musculoskeletal injuries, with a particular emphasis on ACL injuries.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
87mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jul 2022Jul 2033

Study Start

First participant enrolled

July 19, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2032

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2033

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

10 years

First QC Date

October 8, 2024

Last Update Submit

April 14, 2026

Conditions

Keywords

AthletesBiomechanics

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months from baseline

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sampling.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanford Health

Fargo, North Dakota, 58103, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Colin Bond, PhD, MBA

    Sanford Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 10, 2024

Study Start

July 19, 2022

Primary Completion (Estimated)

July 1, 2032

Study Completion (Estimated)

July 1, 2033

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations