An observational study in ACL - Anterior Cruciate Ligament Rupture, ACL Injury and Healthy, sponsored by University of Michigan. Terminated at 2 sites in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-05.
Sponsored by University of Michigan · Observational
Among 11 studies in Anterior Cruciate Ligament Injuries by University of Michigan — 1 open to participants now, 1 under way, none of them phase 3. Anterior Cruciate Ligament Injuries · University of Michigan.
Among the 11 studies in Anterior Cruciate Ligament Injuries by University of Michigan, this one is one of 2 that started in 2018, is the only observational one, and was the 6th registered.
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
This study's enrollment of 13 is below the median of 98 across 153 observational studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →1 of the 11 studies in Anterior Cruciate Ligament Injuries by University of Michigan is open now, in 1 country. Each count lists the studies.
Of the 121 Anterior Cruciate Ligament Injuries studies recruiting now, 27 (22%) set no upper age limit and 91 (75%) stop at 75 or younger; 46 take children under 18; 21 take healthy volunteers.
This study: 18 Years to 30 Years · all sexes · healthy volunteers too.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2018.
Median enrollment 31 across the 10 interventional studies, 13 across the 1 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
1 of the studies in Anterior Cruciate Ligament Injuries by University of Michigan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06529692University of MichiganMichigan Split-belt Treadmill Training Program to Improve Long-Term Knee Biomechanics After ACL Reconstruction | 2026-12 |
Among the 11 studies in Anterior Cruciate Ligament Injuries by University of Michigan, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Community sample
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with ACL tears
Procedure: Anterior cruciate ligament reconstruction
Healthy subjects
Primary surgical reconstruction of the rupture anterior cruciate ligament
Change in Articular cartilage surface roughness
One-year change in articular cartilage surface roughness based on quantitative morphological assessment with 3D MRI.
Time frame: Baseline (preop), 12 months
Change in Serum Cartilage Oligomeric Matrix Protein (COMP) concentration
One-year change in the serum concentration of COMP, a biomarker of articular cartilage degeneration.
Time frame: Baseline (preop), 12 months
Change in International Knee Documentation Committee (IKDC) score
One year change in IKDC, a patient-reported outcome measure specific to knee injuries.
Time frame: Baseline (preop), 12 months
Change in quantitative T2 mapping and T1rho mapping relaxation times from MRI.
Time frame: Baseline (preop), 12 months
Change in concentration of biomarkers of inflammation and cartilage metabolism.
Time frame: Baseline (preop), 12 months
Change in patient-reported outcome measures
Time frame: Baseline (preop), 12 months
Change in knee laxity
Knee laxity will be measured with KT-2000 testing
Time frame: Baseline (preop), 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2018 to primary completion in Mar 2021, 28 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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