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NCT06156501 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

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
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