Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction:
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 30 |
| Updated: | 4/17/2018 |
| Start Date: | February 1, 2018 |
| End Date: | February 1, 2021 |
| Contact: | Elizabeth Enselman, ATC |
| Email: | esiblisk@med.umich.edu |
| Phone: | 734-615-0768 |
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
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.
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.
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.
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.
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
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