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

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT06156501
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
22
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: ACL Reconstruction
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Psychological Factors Influencing the Patient-reported and Functional Outcome of ACL Reconstruction and Their Sex-specific Differences
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: ACL Reconstruction

Patients undergoing ACL reconstruction

Procedure: ACL Reconstruction
Reconstruction of the anterior cruciate ligament

Outcome Measures

Primary Outcome Measures

  1. Patient-reported Knee Function (Lysholm Knee Score, Points) [0 to 12 months after surgery]

    Established patient-reported knee related score

  2. Objective Knee Function [0 to 12 months after surgery]

    Standardized physiotherapeutical return to sports test battery, (pass/no pass)

  3. Psychological Status (ACL-RSI, points) [0 to 12 months after surgery]

    Established psychological self-awareness score

  4. Patient Pain (Visual Analoge Scale (points) [0 to 12 months after surgery]

    Patient reported pain

Secondary Outcome Measures

  1. Graft Maturation [6 months postoperative]

    Knee MRI assessing graft maturation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lorenz Pichler, MD, Resident Doctor, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT06156501
Other Study ID Numbers:
  • 100391
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lorenz Pichler, MD, Resident Doctor, Medical University of Vienna
Psychology
Gender Medicine
Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Dec 5, 2023