NCT04408885

Brief Summary

The purpose with this present study is to investigate the effect og a non-surgical regime in patients with an Anterior Cruciate ligament injury. The effect will be measured by patient reported outcome scores, level of function and how many of the patients are converting to operative treatment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Aug 2020

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

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Study Timeline

Key milestones and dates

Study Progress55%
Aug 2020Dec 2030

First Submitted

Initial submission to the registry

May 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

7.4 years

First QC Date

May 26, 2020

Last Update Submit

September 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in patient reported outcome score (IKDC)

    The International Knee Documentation Committee (0-100)

    Baseline - 2 Years

Secondary Outcomes (3)

  • Changes in patient reported outcome score (KOOS)

    Baseline - 2 Years

  • Changes in patient reported outcome score (KNEES-ACL)

    Baseline - 2 Years

  • Changes in patient reported outcome score (TEGNER)

    Baseline - 2 Years

Interventions

Non-surgical interventions to patients with an Anterior cruciate ligament injury. Rehabilitation regime is the regime provided by the physician at the rehabilitation clinic.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

We will include 400 patients with Anterior cruciate ligament injury. Patients will be included at different orthopaedic Clinics at 5 hospitals in Region Midtjylland.

You may qualify if:

  • Anterior cruciate ligament injury where rehabilitation regime is selected as treatment.

You may not qualify if:

  • Other knee ligament instability
  • Rheumatoid arthritis
  • Morbus Bechterews Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Sports Trauma, Palle Juul-Jensens Boulevard 99

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Torsten G Nielsen, PT

CONTACT

Martin Lind, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 26, 2020

First Posted

May 29, 2020

Study Start

August 15, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2030

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Data will not be available for other researchers

Locations