Cartilage Injury Clinical Trial
Official title:
Prospective, Randomized, Single Blind Clinical Trial to Investigate the Impact of Autologous Bone Marrow Concentrate in Knee Osteochondral Allograft Transplantation
NCT number | NCT04739930 |
Other study ID # | 17121805 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2, 2018 |
Est. completion date | January 12, 2023 |
Verified date | January 2023 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study is to establish if mesenchymal stem cell augmentation improves graft incorporation and to analyze the cytokine environment of the joint after osteochondral allograft transplantation (OCA) with and without intra-articular bone marrow aspirate concentrate (BMAC) injection. Information learned from this study can be used to biochemically compare treatment response and to assess emerging therapeutic options that may positively alter the biochemical environment in patients who suffer from articular cartilage disorders.
Status | Completed |
Enrollment | 33 |
Est. completion date | January 12, 2023 |
Est. primary completion date | January 12, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: • Patients aged 18-50 with a cartilage defect indicated for treatment with osteochondral allograft Exclusion Criteria: - Patients with known rheumatoid arthritis, any other inflammatory arthropathy or synovial tissue disorder. - Patients with known bipolar osteoarthritis of the knee as determined by the treating physician, greater than Kellegren-Lawrence Grade 3 on x-ray imaging - Patient with a known infection or history of infection in the affected knee |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center | Joint Restoration Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Radiographic analysis | Changes in graft status will be analysed using radiographic analysis | Day 1, Post-operative 2 weeks, 6 weeks, 12, weeks, 24 weeks, 52 weeks | |
Other | Computed Tomography (CT) analysis | Changes in graft status will be analysed using Computed Tomography (CT) analysis | Post-operative 24 weeks | |
Primary | Synovial Fluid Cytokine Measurement | To measure the amount of cytokines and cartilage biomarkers in the synovial fluid of patients undergoing osteochondral allograft transplantation with and without BMAC augmentation at different time points | Up to 52 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03479775 -
Muscle Function and Traumatic Knee Injury in Sports
|
||
Recruiting |
NCT03321812 -
Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee
|
N/A | |
Recruiting |
NCT06082531 -
Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis
|
N/A | |
Completed |
NCT06078072 -
Biomaterials and Mesenchymal Stem/Stromal Cells in the Treatment of Knee Articular Surface Lesions
|
||
Completed |
NCT04889443 -
Spontaneous Healing of ARticular Cartilage (SHARC)
|
||
Completed |
NCT04118023 -
7T MRI to Evaluate Cartilage Defects in the Knee
|
||
Active, not recruiting |
NCT01458782 -
ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee
|
N/A | |
Recruiting |
NCT03477942 -
Impact of Mesenchymal Stem Cells in Knee Osteoarthritis
|
Phase 1 | |
Completed |
NCT01473199 -
BioPoly RS Knee Registry Study for Cartilage Defect Replacement
|
N/A | |
Recruiting |
NCT05124613 -
The Impact of Covid-19 on Patients Waiting for Knee Surgery
|
||
Recruiting |
NCT06344481 -
The Hyalex First-in-Human Study
|
Phase 1 | |
Active, not recruiting |
NCT03873545 -
Prospective Evaluation of ProChondrix CR for Repair of Articular Cartilage Defects on Femoral Condyle and Patella
|
||
Recruiting |
NCT05328674 -
Clinical and Comparative Evaluation of the Treatment Results of Arthroscopic Reconstruction of Cartilage Defects in the Knee Joint With the Use of Autogenous Cartilage Graft With PRP GF (Platelet-rich Plasma With Growth Factors)
|
N/A | |
Recruiting |
NCT04184687 -
The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
|
N/A | |
Terminated |
NCT04301258 -
ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry
|
||
Completed |
NCT02696876 -
Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair
|
N/A | |
Completed |
NCT02637505 -
Norwegian Cartilage Project - Microfracture
|
N/A | |
Recruiting |
NCT04135950 -
Prospective Registry of Anterior Cruciate Ligament Reconstructions
|
||
Completed |
NCT03024801 -
Effectiveness of Autologous Platelet-rich Plasma on Knee Cartilage Injury
|
N/A | |
Completed |
NCT01041001 -
Study to Compare Efficacy and Safety of Cartistem and Microfracture in Patients With Knee Articular Cartilage Injury
|
Phase 3 |