NCT06156501

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

November 15, 2023

Last Update Submit

November 27, 2023

Conditions

ACL Tear

Keywords

PsychologyGender Medicine

Outcome Measures

Primary Outcomes (4)

  • Patient-reported Knee Function (Lysholm Knee Score, Points)

    Established patient-reported knee related score

    0 to 12 months after surgery

  • Objective Knee Function

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

    0 to 12 months after surgery

  • Psychological Status (ACL-RSI, points)

    Established psychological self-awareness score

    0 to 12 months after surgery

  • Patient Pain (Visual Analoge Scale (points)

    Patient reported pain

    0 to 12 months after surgery

Secondary Outcomes (1)

  • Graft Maturation

    6 months postoperative

Study Arms (1)

ACL Reconstruction

EXPERIMENTAL

Patients undergoing ACL reconstruction

Procedure: ACL Reconstruction

Interventions

ACL ReconstructionPROCEDURE

Reconstruction of the anterior cruciate ligament

ACL Reconstruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ACL tear
  • Over 18 years
  • Patient information and consent
  • No preexisting knee conditions prior ACL tear;

You may not qualify if:

  • Under 18 years
  • Preexisting knee conditions
  • Accompanying knee injuries apart from ACL tear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Lorenz Pichler, MD

CONTACT

+43 1 40400-56190lorenz.pichler@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

November 15, 2023

First Posted

December 5, 2023

Study Start

August 1, 2023

Primary Completion

January 1, 2025

Study Completion

June 1, 2025

Last Updated

December 5, 2023

Record last verified: 2023-11

Locations

AU(1)