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UnknownNCT04970706

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
Phase
Study type
Observational
Enrollment
76 (estimated)
Sponsor
Peking University Third Hospital · Academic / Other
Sex
All
Age
18 Years – 30 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

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

Timeline

Start date
2021-01-01
Primary completion
2023-01-01
Completion
2023-01-01
First posted
2021-07-21
Last updated
2021-07-21

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04970706. Inclusion in this directory is not an endorsement.