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Cartilage Injury and Remodeling After ACL Rupture and Reconstruction: Functional Imaging and Biomarkers

Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction: A Correlational Study of Functional Imaging and Biomarkers

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04970706
Enrollment
76
Registered
2021-07-21
Start date
2021-01-01
Completion date
2023-01-01
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries

Brief summary

The proposed study will establish novel relationships between intra-articular MSC recruitment, synovial inflammation, biomarkers of cartilage degeneration and joint inflammation, clinical patient factors, and downstream alterations in cartilage composition and morphology to provide novel insights into the pathoetiology of PTOA after ACL injury and reconstruction.

Detailed description

In efforts to study the pathoetiology of post-traumatic osteoarthritis (PTOA), we propose a collaborative, prospective cohort study of 38 patients undergoing primary anterior cruciate ligament (ACL) reconstruction after ACL rupture. We will assess the longitudinal progression of patient-reported outcomes, knee laxity, MRI-based articular cartilage morphology and composition, and serum-borne biomarkers of cartilage degeneration up to 1 year of follow-up. Furthermore, stem cell mobilization, chemokine and pro-inflammatory cytokine concentrations, and inflammatory cell recruitment into synovial tissue will be measured from intraoperatively-collected samples. We will perform mixed multivariate linear regression modeling to elucidate potentially novel relationships between patient demographics, anatomy, biological factors, and downstream alterations in articular cartilage morphology and composition. We request $200,000 in funding over a two-year duration.

Interventions

PROCEDUREACL reconstruction

All patients will undergo a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft.

Sponsors

University of Michigan
CollaboratorOTHER
Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* \- Males and females, aged 18 - 30 years * Isolated, traumatic primary anterior cruciate ligament rupture requiring surgical reconstruction * Surgical reconstruction performed using a single-bundle technique utilizing an autograft * No history of ipsilateral traumatic knee injury or fracture * No evidence of PCL injury or more than grade 1 injury to the MCL or LCL

Exclusion criteria

* \- BMI \< 18.5 or \>35 kg/m2 * Injury occurred longer than 4 weeks before enrollment * Intra-articular steroid injection within 3 months of injury * Chondral defects greater than 3 cm2 or Outerbridge grade II or higher lesions

Design outcomes

Primary

MeasureTime frameDescription
Magnetic resonance imaging12 months after operationQuantitative MRI of Cartilage Composition
MMP-112 months after operationSoft Tissue Protease and Protease Inhibitor Analysis in Synovial Fluid
colony-forming units (CFU)12 months after operationThe CFU assay is a common means of analyzing MSC concentration in bodily fluids
Cartilage morphology12 months after operationQuantitative MRI of cartilage morphology
Objectives measure of knee stability3 months, 6 months, 12 monthsKnee stability (anterior-posterior laxity) will be measured utilizing the KT-2000 arthrometer, based on the side-to-side difference (SSD) observed between the injured and the healthy, contralateral knee. Subjects will be tested at 90 days, 180 days, and 1 year after surgery, with maximum manual force performed at 30 and 90 degrees of knee flexion.
COMP12 months after operationCartilage Biomarker Analysis;
Interleukin-112 months after operationChemokines and Pro-Inflammatory Cytokines in Synovial Fluid;

Secondary

MeasureTime frameDescription
Lysholm Knee Scale12 months after operationknee evaluation are commonly used to document a patient's functional outcomes
International Knee Documentation Committee (IKDC) subjective Scale12 months after operationknee evaluation are commonly used to document a patient's functional outcomes
Tegner Activity Scale12 months after operationknee evaluation are commonly used to document a patient's activity level

Countries

China

Contacts

Primary Contactyanfang jiang, Msc.
anthea_jiang@126.com15011420759

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026