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

P

Peking University

Status

Unknown

Conditions

Anterior Cruciate Ligament Injuries

Treatments

Procedure: ACL reconstruction

Study type

Observational

Funder types

Other

Identifiers

NCT04970706
M2017401

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

76 participants in 2 patient groups

Healthy Volunteers
Description:
Volunteers were healthy people without ACL rupture
Patients with ACL Rupture
Description:
All patients will undergo a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft.
Treatment:
Procedure: ACL reconstruction

Trial contacts and locations

1

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Central trial contact

yanfang jiang, Msc.

Data sourced from clinicaltrials.gov

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