Osteoarthritis (OA) of the KneePROTO-WP4NCT06596824
Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction
A study testing Training intervention in people with Osteoarthritis (OA) of the Knee and ACL Reconstruction, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
Osteoarthritis (OA) is a condition that causes pain and stiffness in the joints, often due to injuries like torn ligaments. Even after surgery, these injuries can lead to long-term joint problems. Current treatments don\'t fully prevent OA from developing. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee, ACL Reconstruction
- What is being tested?
- Training intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed written informed consent
- Adult subjects between 18 to 50 years old at the time of screening
- Primary ACL reconstruction within a maximum of 6 months after a unilateral ACL injury
- Complete baseline assessment between 8 and 12 weeks after ACL reconstruction
Who cannot join
- Significant trauma to a weight-bearing joint within 12 months prior to study initiation (excluding the ACL injury)
- Previous surgeries on the study knee (except for the ACL reconstruction)
- Signs of knee OA as defined by the OARSI-Joint Space Narrowing (JSN) Score of two or more (standing AP x-ray)
- Physical activity level: Tegner activity score before injury of 0-2 (very low activity) or 8-10 (very high activity)
- Body mass index ≥ 30 kg/m2;
- Inflammatory arthropathies;
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- Immunosuppression due to illness or medication;
- Sepsis or hemostasis disorders;
- Severe uncontrolled inflammatory disease or autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc.);
- Having malignancy and undergoing treatment including chemotherapy, radiotherapy, or immunotherapy;
- Contraindications for MRI, including pacemakers, defibrillators, metal implants, pregnancy, sensorineural hearing loss above 30 dB, tinnitus and claustrophobia
- Unable to freely give their informed consent (e.g., individuals under legal guardianship).
- Currently enrolled in or has not yet completed a period of at least 5 times as the half-life time of the drug used in the previous trial since ending other investigational device or drug trial(s)
- Patients who are dependent on the sponsor, investigator, or study site;
- Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index < 1);
- Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel;
- Patients who are committed to an institution by virtue of an order issued by either the judicial or the administrative authorities;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin, BeMoveD - Berlin Movement Diagnostics
Berlin, 10117
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117
Winkler, Prof.Dr.med., +49 30 450 559084, tobias.winkler@charite.de
About this study
Official title: Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis (OA)
Osteoarthritis (OA) is a condition that causes pain and stiffness in the joints, often due to injuries like torn ligaments. Even after surgery, these injuries can lead to long-term joint problems. Current treatments don\'t fully prevent OA from developing. This study is testing a new 12-week exercise program designed to improve how the knee moves, using a special sensor-based system. The goal is to reduce joint inflammation and prevent the development of OA in patients who have had knee surgery.
- Being tested
- Training intervention
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training interventionBehavioural
Personalized digital training intervention aims to correct pathological knee movement and loading patterns and reduce inflammation in pre-stage knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| The treatment group | Experimental | In addition to the standard-of-care physiotherapy program, the treatment group will additionally receive a training intervention utilizing sensor-based technology that provides 3D avatar training, supported by an accompanying app, to deliver personalized exercise regimens. This intervention aims to correct the pathological knee movement and loading patterns that exacerbate joint inflammation and contribute to the development of knee OA. Receives: Behavioral: Training intervention |
| the control group | No intervention | Standard-of-care physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
Restoration of normal knee angle and moment patterns during walking at 6-month follow-up (compared to normative data), as determined by a machine learning-derived gait index.
Measured: at 6-month follow-up visit
Secondary outcomes (7)
Secondary Endpoint: Cartilage Thickness
Quantitative magnetic resonance imaging measurement of cartilage thickness, expressed in millimeters (mm), across predefined articular sub-regions of the knee.
Measured: Baseline, 6, and 36 months follow-up visits
Secondary Endpoint: Cartilage Volume
Quantitative magnetic resonance imaging measurement of cartilage volume, expressed in cubic millimeters (mm³), across predefined articular sub-regions of the knee.
Measured: Baseline, 6, and 36 months follow-up visits
Secondary Endpoint: Cartilage Composition
Quantitative magnetic resonance imaging measurement of cartilage composition using laminar T2 relaxation time, expressed in milliseconds (ms), reflecting cartilage water content and collagen organization across predefined articular sub-regions of the knee.
Measured: Baseline, 6, and 36 months follow-up visits
Secondary Endpoint: Meniscus Position
Quantitative magnetic resonance imaging measurement of meniscus extrusion, expressed in millimeters (mm), defined as the distance the meniscus extends beyond the edge of the tibial plateau.
Measured: Baseline, 6, and 36 months follow-up visits
Secondary Endpoint: Hoffa Synovitis
Quantitative magnetic resonance imaging measurement of Hoffa synovitis, expressed as a signal distribution pattern (dimensionless) within the infrapatellar (Hoffa's fat pad) region.
Measured: Baseline, 6, and 36 months follow-up visits
Secondary Endpoint: Effusion Synovitis
Quantitative magnetic resonance imaging measurement of joint effusion and synovitis, expressed as synovial fluid volume in cubic millimeters (mm³).
Measured: Baseline, 6, and 36 months follow-up visits
Secondary Endpoint: Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)
Semi-quantitative assessment of structural pathology using the Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS), where scores range from 0 (no cartilage damage) to 3 (severe cartilage damage), with higher scores indicating greater pathology, across fourteen articular sub-regions.
Measured: Baseline, 6, and 36 months follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Winkler, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596824
- Sponsor's protocol ID
- PROTO-WP4
- Other IDs
- 101095635
- Acronym
- PROTO-WP4
- Status last verified
- Feb 2026
- First submitted
- 9 Sep 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT06596824
- Acronym / sponsor ID
- PROTO-WP4 / PROTO-WP4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
Osteoarthritis (OA) is a condition that causes pain and stiffness in the joints, often due to injuries like torn ligaments. Even after surgery, these injuries can lead to long-term joint problems. Current treatments don\'t fully prevent OA from developing. This study is testing a new 12-week exercise program designed to improve how the knee moves, using a special sensor-based system. The goal is to reduce joint inflammation and prevent the development of OA in patients who have had knee surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The treatment group | Experimental | Behavioral: Training interventionIn addition to the standard-of-care physiotherapy program, the treatment group will additionally receive a training intervention utilizing sensor-based technology that provides 3D avatar training, supported by an accompanying app, to deliver personalized exercise regimens. This intervention aims to correct the pathological knee movement and loading patterns that exacerbate joint inflammation and contribute to the development of knee OA. |
| the control group | No intervention | –Standard-of-care physiotherapy program |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed written informed consent
- Adult subjects between 18 to 50 years old at the time of screening
- Primary ACL reconstruction within a maximum of 6 months after a unilateral ACL injury
- Complete baseline assessment between 8 and 12 weeks after ACL reconstruction
Key exclusion criteria (17 listed)
- Significant trauma to a weight-bearing joint within 12 months prior to study initiation (excluding the ACL injury)
- Previous surgeries on the study knee (except for the ACL reconstruction)
- Signs of knee OA as defined by the OARSI-Joint Space Narrowing (JSN) Score of two or more (standing AP x-ray)
- Physical activity level: Tegner activity score before injury of 0-2 (very low activity) or 8-10 (very high activity)
- Body mass index ≥ 30 kg/m2;
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 |
|---|---|---|
| Training interventionPersonalized digital training intervention aims to correct pathological knee movement and loading patterns and reduce inflammation in pre-stage knee osteoarthritis. | Behavioural | The treatment group |
Primary outcome
Primary Endpoint
Time frame: at 6-month follow-up visit
Restoration of normal knee angle and moment patterns during walking at 6-month follow-up (compared to normative data), as determined by a machine learning-derived gait index.
7 secondary outcomes
Secondary Endpoint: Cartilage Thickness
Time frame: Baseline, 6, and 36 months follow-up visits
Secondary Endpoint: Cartilage Volume
Time frame: Baseline, 6, and 36 months follow-up visits
Secondary Endpoint: Cartilage Composition
Time frame: Baseline, 6, and 36 months follow-up visits
Secondary Endpoint: Meniscus Position
Time frame: Baseline, 6, and 36 months follow-up visits
Secondary Endpoint: Hoffa Synovitis
Time frame: Baseline, 6, and 36 months follow-up visits
Secondary Endpoint: Effusion Synovitis
Time frame: Baseline, 6, and 36 months follow-up visits
Secondary Endpoint: Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)
Time frame: Baseline, 6, and 36 months follow-up visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training intervention in people with Osteoarthritis (OA) of the Knee and ACL Reconstruction, run by Charite University, Berlin, Germany at 2 sites in Germany.
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 17 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Winkler, Prof. Dr.med. (+49 30 450 559084, tobias.winkler@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: at 6-month follow-up visit). 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 2 Mar 2026.