Rehabilitation Treatment of Anterior Cruciate Ligament Rupture

ACL Injury Clinical Trial

Official title:

Rehabilitation Treatment of Anterior Cruciate Ligament Rupture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04408885
• Other study ID #: Danish EC: 1-10-72-25-20
• Status: Recruiting
• Start date: August 15, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: July 2023
• Source: Aarhus University Hospital
• Contact: Torsten G Nielsen, PT
• Phone: +4540491184
• Email: torsne[@]rm.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries
• Rupture

Intervention

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

Locations

Country	Name	City	State
Denmark	Division of Sports Trauma, Palle Juul-Jensens Boulevard 99	Aarhus N

Sponsors (5)

Lead Sponsor	Collaborator
Aarhus University Hospital	Central Jutland Regional Hospital, Herning Hospital, Horsens Hospital, Regionshospitalet Silkeborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in patient reported outcome score (IKDC)	The International Knee Documentation Committee (0-100)	Baseline - 2 Years
Secondary	Changes in patient reported outcome score (KOOS)	Knee injury and Osteoarthritis Outcome Score (0-100)	Baseline - 2 Years
Secondary	Changes in patient reported outcome score (KNEES-ACL)	Knee Numeric-Entity Evaluation Score (0-100)	Baseline - 2 Years
Secondary	Changes in patient reported outcome score (TEGNER)	Activity scale (0-10)	Baseline - 2 Years