ACL TearNCT06156501
Psychological Factors Influencing the Patient-reported and Functional Outcome of ACL Reconstruction and Their Sex-specific Differences
A study testing ACL Reconstruction in people with ACL Tear, run by Medical University of Vienna at 1 site in Austria.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACL Tear
- What is being tested?
- ACL Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACL tear
- Over 18 years
- Patient information and consent
- No preexisting knee conditions prior ACL tear;
Who cannot join
- Under 18 years
- Preexisting knee conditions
- Accompanying knee injuries apart from ACL tear
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Lorenz Pichler, MD, +43 1 40400-56190, lorenz.pichler@meduwien.ac.at
About this study
Psychological parameters among patients undergoing ACL reconstruction and their impact on the patient-reported and functional outcome of reconstruction will be prospectively evaluated
- Conditions
- ACL Tear
- Being tested
- ACL Reconstruction
- Keywords
- Psychology, Gender Medicine
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL ReconstructionProcedure or surgery
Reconstruction of the anterior cruciate ligament
| Study group | Role | What they receive |
|---|---|---|
| ACL Reconstruction | Experimental | Patients undergoing ACL reconstruction Receives: Procedure: ACL Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported Knee Function (Lysholm Knee Score, Points)
Established patient-reported knee related score
Measured: 0 to 12 months after surgery
Objective Knee Function
Standardized physiotherapeutical return to sports test battery, (pass/no pass)
Measured: 0 to 12 months after surgery
Psychological Status (ACL-RSI, points)
Established psychological self-awareness score
Measured: 0 to 12 months after surgery
Patient Pain (Visual Analoge Scale (points)
Patient reported pain
Measured: 0 to 12 months after surgery
Secondary outcomes (1)
Graft Maturation
Knee MRI assessing graft maturation
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Aug 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL TearStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenz Pichler, MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156501
- Sponsor's protocol ID
- 100391
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Factors Influencing the Patient-reported and Functional Outcome of ACL Reconstruction and Their Sex-specific Differences
- ClinicalTrials.gov ID
- NCT06156501
- Acronym / sponsor ID
- 100391
- Conditions
- ACL Tear
- Keywords
- Psychology, Gender Medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psychological parameters among patients undergoing ACL reconstruction and their impact on the patient-reported and functional outcome of reconstruction will be prospectively evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL Reconstruction | Experimental | Procedure: ACL ReconstructionPatients undergoing ACL reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ACL tear
- Over 18 years
- Patient information and consent
- No preexisting knee conditions prior ACL tear;
Key exclusion criteria (3 listed)
- Under 18 years
- Preexisting knee conditions
- Accompanying knee injuries apart from ACL tear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL ReconstructionReconstruction of the anterior cruciate ligament | Procedure or surgery | ACL Reconstruction |
Primary outcome
Patient-reported Knee Function (Lysholm Knee Score, Points)
Time frame: 0 to 12 months after surgery
Established patient-reported knee related score
Objective Knee Function
Time frame: 0 to 12 months after surgery
Standardized physiotherapeutical return to sports test battery, (pass/no pass)
Psychological Status (ACL-RSI, points)
Time frame: 0 to 12 months after surgery
Established psychological self-awareness score
Patient Pain (Visual Analoge Scale (points)
Time frame: 0 to 12 months after surgery
Patient reported pain
1 secondary outcome
Graft Maturation
Time frame: 6 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL Reconstruction in people with ACL Tear, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenz Pichler, MD (+43 1 40400-56190, lorenz.pichler@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported Knee Function (Lysholm Knee Score, Points) (time frame: 0 to 12 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.