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Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction:

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03497780
Enrollment
13
Registered
2018-04-13
Start date
2018-11-08
Completion date
2021-03-25
Last updated
2023-04-05

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

Conditions

ACL - Anterior Cruciate Ligament Rupture, ACL Injury, Healthy

Keywords

Healthy Volunteers, ACL (Anterior Cruciate Ligament) tear

Brief summary

The proposed study will establish novel relationships between intra-articular mesenchymal stem cell (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 post-traumatic osteoarthritis (PTOA) after ACL injury and reconstruction. The study aims to enroll N=38 total patients with primary, isolated rupture to their anterior cruciate ligament (ACL), who have agreed to participate in the study and who will undergo primary surgical reconstruction by an orthopaedic physician at our two sites. Patients will undergo baseline magnetic resonance imaging (MRI), baseline clinical evaluation, and undergo a baseline blood draw. Subsequent imaging and clinical evaluations will be longitudinally performed at several postoperative timepoints up to 12 months postoperatively.

Detailed description

Overall Study Design: This is a prospective, longitudinal cohort study of patients undergoing primary ACL reconstruction following ACL rupture. Surgical treatment and treatment timelines do not deviate from the national and international standards of care. Enrolled patients for study participation will undergo assessments involving blood, urine, and synovial fluid collection, clinical evaluation involving questionnaires and joint laxity testing, and MRI analysis. Patient Selection and Enrollment: The participating physicians at each site will identify potential subjects from their clinics' patients according to the inclusion/exclusion criteria listed below. Based on surgical volumes at both sites, patients generally undergo ACL reconstruction 8-12 weeks after initial screening. In the preoperative timeframe, all patients will undergo standard physical therapy to address pain, swelling, and motion deficits, as is standard of care at both institutions. Arthroscopic ACL reconstruction will be performed by Dr. Bedi at the University of Michigan, by Professor Ao at Peking University, and by 5 additional surgeons at Peking University. All surgeons will utilize a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft.

Interventions

PROCEDUREAnterior cruciate ligament reconstruction

Primary surgical reconstruction of the rupture anterior cruciate ligament

Sponsors

Peking University Health Science Center
CollaboratorOTHER
University of Michigan
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

* 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 Posterior Cruciate Ligament injury or more than grade 1 injury to the Medial or Lateral Collateral Ligament

Exclusion criteria

* Body Mass Index \< 18.5 or \>35 - 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 * Pregnant women as they are not eligible for surgery

Design outcomes

Primary

MeasureTime frameDescription
Change in Articular cartilage surface roughnessBaseline (preop), 12 monthsOne-year change in articular cartilage surface roughness based on quantitative morphological assessment with 3D MRI.
Change in Serum Cartilage Oligomeric Matrix Protein (COMP) concentrationBaseline (preop), 12 monthsOne-year change in the serum concentration of COMP, a biomarker of articular cartilage degeneration.
Change in International Knee Documentation Committee (IKDC) scoreBaseline (preop), 12 monthsOne year change in IKDC, a patient-reported outcome measure specific to knee injuries.

Secondary

MeasureTime frameDescription
Change in quantitative T2 mapping and T1rho mapping relaxation times from MRI.Baseline (preop), 12 months
Change in knee laxityBaseline (preop), 12 monthsKnee laxity will be measured with KT-2000 testing
Change in concentration of biomarkers of inflammation and cartilage metabolism.Baseline (preop), 12 months
Change in patient-reported outcome measuresBaseline (preop), 12 months

Countries

United States

Outcome results

None listed

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