Personalized Digital Training Intervention to Reduce Inflammation by Correcting Pathological Movement Patterns in Pre-stage Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction

NCT06596824 | Recruiting DMC

• 2 other identifiers: PROTO-WP4101095635
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

ACL Reconstruction; Osteoarthritis (OA) of the Knee

Outcome Measures

Primary Outcomes (1)

• 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.

  at 6-month follow-up visit

Secondary Outcomes (7)

• Secondary Endpoint: Cartilage Thickness

  Baseline, 6, and 36 months follow-up visits

• Secondary Endpoint: Cartilage Volume

  Baseline, 6, and 36 months follow-up visits

• Secondary Endpoint: Cartilage Composition

  Baseline, 6, and 36 months follow-up visits

• Secondary Endpoint: Meniscus Position

  Baseline, 6, and 36 months follow-up visits

• Secondary Endpoint: Hoffa Synovitis

  Baseline, 6, and 36 months follow-up visits

Other Outcomes (3)

• Exploratory Endpoint: Biomarkers of Joint Tissue Remodeling

  Baseline, 6, and 36 months follow-up visits

• Exploratory Endpoint: Inflammatory Cytokines

  Baseline, 6, and 36 months follow-up visits

• Exploratory Endpoint: Cellular Biomarkers

  Baseline, 6, and 36 months follow-up visits

Study Arms (2)

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.

Behavioral: Training intervention

the control group

NO INTERVENTION

Standard-of-care physiotherapy program

Interventions

Training intervention BEHAVIORAL

Personalized digital training intervention aims to correct pathological knee movement and loading patterns and reduce inflammation in pre-stage knee osteoarthritis.

The treatment group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (2)

Charité - Universitätsmedizin Berlin, BeMoveD - Berlin Movement Diagnostics

Berlin, 10117, Germany

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Winkler, Prof. Dr.med.

CONTACT

+49 30 450 559084; tobias.winkler@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.med.

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)