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

NCT04970706 | Unknown DMC

• 1 other identifier: M2017401
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (7)

• 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

• COMP

  Cartilage Biomarker Analysis;

  12 months after operation

• Interleukin-1

  Chemokines and Pro-Inflammatory Cytokines in Synovial Fluid;

  12 months after operation

• MMP-1

  Soft Tissue Protease and Protease Inhibitor Analysis in Synovial Fluid

  12 months after operation

• colony-forming units (CFU)

  The CFU assay is a common means of analyzing MSC concentration in bodily fluids

  12 months after operation

• Cartilage morphology

  Quantitative MRI of cartilage morphology

  12 months after operation

• Magnetic resonance imaging

  Quantitative MRI of Cartilage Composition

  12 months after operation

Secondary Outcomes (3)

• Tegner Activity Scale

  12 months after operation

• Lysholm Knee Scale

  12 months after operation

• International Knee Documentation Committee (IKDC) subjective Scale

  12 months after operation

Study Arms (2)

Healthy Volunteers

Volunteers were healthy people without ACL rupture

Patients with ACL Rupture

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

Procedure: ACL reconstruction

Interventions

ACL reconstruction PROCEDURE

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

Patients with ACL Rupture

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• University of Michigan: collaborator

Study Sites (1)

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• yingfang ao, M.D.

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

yanfang jiang, Msc.

CONTACT

15011420759; anthea_jiang@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 21, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: July 21, 2021

Record last verified: 2021-06

Locations

CN (1)