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

November 27, 2023 updated by: Lorenz Pichler, MD, Medical University of Vienna
Psychological parameters among patients undergoing ACL reconstruction and their impact on the patient-reported and functional outcome of reconstruction will be prospectively evaluated

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACL Reconstruction
Patients undergoing ACL reconstruction
Procedure: ACL Reconstruction
Reconstruction of the anterior cruciate ligament

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported Knee Function (Lysholm Knee Score, Points)
Time Frame: 0 to 12 months after surgery
Established patient-reported knee related score
0 to 12 months after surgery
Objective Knee Function
Time Frame: 0 to 12 months after surgery
Standardized physiotherapeutical return to sports test battery, (pass/no pass)
0 to 12 months after surgery
Psychological Status (ACL-RSI, points)
Time Frame: 0 to 12 months after surgery
Established psychological self-awareness score
0 to 12 months after surgery
Patient Pain (Visual Analoge Scale (points)
Time Frame: 0 to 12 months after surgery
Patient reported pain
0 to 12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft Maturation
Time Frame: 6 months postoperative
Knee MRI assessing graft maturation
6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100391

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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