Psychological Factors Influencing the Patient-reported and Functional Outcome of ACL Reconstruction and Their Sex-specific Differences

ACL Tear Clinical Trial

Official title:

Psychological Factors Influencing the Patient-reported and Functional Outcome of ACL Reconstruction and Their Sex-specific Differences

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06156501
• Other study ID #: 100391
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: November 2023
• Source: Medical University of Vienna
• Contact: Lorenz Pichler, MD
• Phone: +43 1 40400-56190
• Email: lorenz.pichler[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Psychological parameters among patients undergoing ACL reconstruction and their impact on the patient-reported and functional outcome of reconstruction will be prospectively evaluated

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ACL tear

• Over 18 years

• Patient information and consent

• No preexisting knee conditions prior ACL tear;

Exclusion Criteria:

• Under 18 years

• Preexisting knee conditions

• Accompanying knee injuries apart from ACL tear

Related Conditions & MeSH terms

• ACL Tear
• Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• ACL Reconstruction
Reconstruction of the anterior cruciate ligament

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported Knee Function (Lysholm Knee Score, Points)	Established patient-reported knee related score	0 to 12 months after surgery
Primary	Objective Knee Function	Standardized physiotherapeutical return to sports test battery, (pass/no pass)	0 to 12 months after surgery
Primary	Psychological Status (ACL-RSI, points)	Established psychological self-awareness score	0 to 12 months after surgery
Primary	Patient Pain (Visual Analoge Scale (points)	Patient reported pain	0 to 12 months after surgery
Secondary	Graft Maturation	Knee MRI assessing graft maturation	6 months postoperative