Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | ACL reconstruction | All 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.