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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04970706
• Other study ID #: M2017401
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: yanfang jiang, Msc.
• Phone: 15011420759
• Email: anthea_jiang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Rupture
• Wounds and Injuries

Intervention

Procedure:
• ACL reconstruction
All patients will undergo a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft.

Locations

Country	Name	City	State
China	Peking university third hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	University of Michigan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objectives measure of knee stability	Knee 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.	3 months, 6 months, 12 months
Primary	COMP	Cartilage Biomarker Analysis;	12 months after operation
Primary	Interleukin-1	Chemokines and Pro-Inflammatory Cytokines in Synovial Fluid;	12 months after operation
Primary	MMP-1	Soft Tissue Protease and Protease Inhibitor Analysis in Synovial Fluid	12 months after operation
Primary	colony-forming units (CFU)	The CFU assay is a common means of analyzing MSC concentration in bodily fluids	12 months after operation
Primary	Cartilage morphology	Quantitative MRI of cartilage morphology	12 months after operation
Primary	Magnetic resonance imaging	Quantitative MRI of Cartilage Composition	12 months after operation
Secondary	Tegner Activity Scale	knee evaluation are commonly used to document a patient's activity level	12 months after operation
Secondary	Lysholm Knee Scale	knee evaluation are commonly used to document a patient's functional outcomes	12 months after operation
Secondary	International Knee Documentation Committee (IKDC) subjective Scale	knee evaluation are commonly used to document a patient's functional outcomes	12 months after operation