NCT04847258

Brief Summary

The aim is to determine the sensitivity and specificity of a screening tool to identify patients who undergo ACL reconstruction (non-copers) after 3 months of standard rehabilitation following an anterior Cruciate ligament (ACL) injury.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
357

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Mar 2021Sep 2027

Study Start

First participant enrolled

March 19, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

5.5 years

First QC Date

April 8, 2021

Last Update Submit

June 30, 2026

Conditions

Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (1)

  • Number of patients undergoing ACL reconstruction after 3 months of standard rehabilitation

    Patients undergoing ACL reconstruction after 3 months of standard rehabilitation are defined as non-copers to the non-surgical treatment, which will define the sensitivity and specificity of the screening examination.

    3 months

Interventions

Standard rehabilitationOTHER

Patients follow standard municipal rehabilitation

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from the outpatient clinic at the Department of Orthopaedic Surgery at Vejle Hospital, Denmark

You may qualify if:

  • unilateral primary ACL injury
  • Index injury no older than 6 months

You may not qualify if:

  • Multiligament rupture
  • Large cartillage or meniscus injuries
  • Scheduled ACL reconstruction within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vejle Hospital

Vejle, Region Syddanmark, 7100, Denmark

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Claus Varnum, ph.d.

    Vejle Hosptal

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 19, 2021

Study Start

March 19, 2021

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

July 1, 2026

Record last verified: 2026-06

Locations

DK(1)