Filter Results
Clinical Studies
Results filtered:Study status:
Open
Closed for Enrollment
Open
-
ASCLEPIOS Autologous Stem CelL Expansion and Prospective Injection for Osteoarthritic hip Symptoms: A Phase I Safety and Feasibility Trial of Autologous Culture Expanded Adipose Derived Mesenchymal Stromal Cells in the Treatment of Painful Hip Osteoarthritis
Rochester, Minn.
Will injection(s) of autologous culture-expanded AMSCs be safe and efficacious for treatment of painful Hip OA, and if so, which dosing regimen is most effective?
-
Knee Biologic Preservation: Functional and Clinical Outcome
Rochester, Minn.
The main purpose of this study is to evaluate the clinical and functional outcomes of patients undergoing biologic knee preservation surgery. Secondary purpose is to identify possible correlation between outcome and pre-operative radiological findings (i.e. bony abnormalities such as mal-alignment, size of cartilage defect).
-
Molecular Characterization of Musculoskeletal Tissues
Rochester, Minn.
The purpose of this investigation is to characterize the genetic and epigenetic characteristics of different musculoskeletal tissues, as well as their associated disease states. Epigenetic markers represent promising therapeutic targets, as well as diagnostic biomarkers with important clinical utility.
-
Shoulder Arthroscopy: Functional and Clinical Outcomes
Rochester, Minn.
The purpose of this study is to evaluate the clinical and functional outcomes of patients undergoing arthroscopic shoulder surgery.
-
STABILITY 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs. Quad Tendon
Rochester, Minn.
The overall primary objective of this 21-site international randomized trial is to determine if graft type (QT, BPTB or HT) with or without a lateral extra-articular tenodesis (LET) will affect the rate of Anterior Cruciate Ligament (ACL) clinical failure 2 years after surgery.
Closed for Enrollment
-
A Multi-Center Feasibility Trial Establishing Imaging and Biochemical Technologies as Measures of Knee Cartilage Composition Following Acute ACL Injury
Rochester, Minn.
This study will evaluate the bio-mechanical and biochemical abnormalities in acute ACL-injured knees over time. Data will be collected through advanced quantitative MR imaging, functional testing, and bio-specimen collection. Researchers will collect this data from the time of baseline visit, which is within 28 days of injury, through the temporal sequence of post-operative or post-injury recovery and return to activity.
The hypotheses for this study are (1) that T1ρ and T2 will be significantly elevated in the lateral side of ACL-injured knees immediately after injury (indicating damage caused by initial injury), and will not fully recover at 6-month, 1-year follow ups; (2) that T1ρ and T2 will be significantly elevated in the medial side of ACL-injured knees at 1-year follow-up; and (3) that differences in the bio-marker expression patterns can be correlated with the initial MRI findings, which would provide information regarding the full spectrum of intra-articular pathology and the subsequent clinical outcomes.
-
A Phase III, Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART 3D Compared to Microfracture in the Treatment of Articular Cartilage Defects (N3D)
Rochester, Minn.
The purpose of this research study is to gather information on the safety and effectiveness of Autologous Chondrocyte Transplantation system, Novocart® 3D, in comparison to standard microfracture treatment for injured knee.
-
A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee
Rochester, Minn.
The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee. The patient population is heterogeneous, involving different kinds of joint surface lesions: focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including multiple defects.
-
A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears (STITCH Study) (STITCH)
Rochester, Minn.
Horizontal meniscus tears meeting specified criteria will be repaired by any commonly used suture technique. Subjects will be followed for 2 years to evaluate the effectiveness of the repair, by assessing the re-operation rate, and by assessing improvements in knee pain and knee function.
-
A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee
Rochester, Minn.
This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.
-
Bony Bankart Lesions in Middle Age and Elderly Patients
Rochester, Minn.
The purpose of this study is to investigate the outcomes for middle-aged and elderly patients who have a traumatic shoulder dislocation resulting in a bony Bankart injury.
-
Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears (NOVOSTITCH PRO)
Rochester, Minn.
The purpose of this study is to understand the benefits and safety of the NOVOSTITCH PRO Meniscal Repair (NOVOSTITCH PRO) system. The meniscus is a tissue in the knee joint. The NOVOSTITCH PRO is used during surgery to fix meniscus tears in the knee. It is unknown whether fixing a meniscus tear is better than the approach of removing the tear. Data will be collected on participants prior to surgery, at surgery, and for 2 years after surgery.
-
CREST: A Randomized Controlled Trial Comparing Inter-portal Hip Capsular Repair vs. No Repair Following Hip Arthroscopy
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
Capsular REpair randomiSed controlled Trial (CREST) is a multi-center, randomized controlled trial with a sample size of 240 patients (120 patients in each group). The primary outcome measure is functional outcome as measured by the change in Hip Outcome Score at 6 months with secondary outcomes being hip range of motion, i-HOT 12, overall satisfaction, and VAS. Patients are stratified based on gender. Patients, outcome assessors, and data analysts are blinded to surgical allocation. Using an intention-to-treat approach, outcome analyses will be performed using an analysis of covariance and descriptive statistics.
-
Hip RECLAIM: A Phase I Safety and Feasibility Trial of REcycled CartiLage Auto/Allo IMplantation for the Treatment and Repair of Focal Hip Cartilage Defects
Rochester, Minn.
The primary objective of the study is to assess the local and systemic safety of a single operative application of autologous chondrons mixed with culture expanded allogeneic AMSCs (RECLAIM) in the treatment of symptomatic focal cartilage defects of the hip.
The secondary objectives of the study are to assess the effect of RECLAIM on pain and function in the target hip, and to assess the effect of RECLAIM on bone and cartilage structures within the target hip using MRI.
-
Metrics of Osteochondral Allografts (MOCA) Registry of the Knee
Rochester, Minn.
The primary objective of this registry is to obtain long-term survivorship data for the use of fresh OCAs in cartilage repair and reconstruction procedures.
-
Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Athletes
Rochester, Minn.,
Minneapolis, Minn.
The overall goal of this project is to reduce risk of second anterior cruciate ligament (ACL) injury in vulnerable populations (active athletes between 14 = 24 years old) through the identification of relative injury risk groups based on subject-specific movement patterns prior to second injury, as well as through the determination of effect for differential rehabilitation protocols following initial ACL reconstruction and prior to return to sport. As nearly one-third of athletes who have a primary ACL injury and return to sport will experience a secondary injury, results from the proposed work will allow us to prospectively identify high risk patients who are the most appropriate recipients of enhanced treatment, including targeted training, which may reduce the risk of second ACL injury. Secondary ACL injury has the potential to end athletic careers, promote the development of osteoarthritis, and have debilitating effects on quality of life. Hence, the information gathered in this investigation will offer ACL injured athletes the optimal potential to reduce or potentially prevent these negative health effects before they are initiated.
-
Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter International Trial
Rochester, Minn.
The purpose of this study is to compare individuals with meniscal root tears that are treated surgically with a meniscal root repair compared to those that are treated without surgery and instead receive anti-inflammatory medications, physical therapy and have a temporary period in which they do not put any weight on the leg.
-
Prospective Study of Patellofemoral Articular Cartilage Defects of the Knee Treated with Cartiform®
Rochester, Minn.
The purpose of this study is to gather clinical outcomes data and imaging for patients who are receiving Cartiform for articular cartilage defects as a standard of care treatment.
-
RECLAIM: A Phase I Safety and Feasibility Trial of REcycled CartiLage Auto/Allo IMplantation for the Treatment and Repair of Focal Knee Cartilage Defects (RECLAIM)
Rochester, Minn.
The purpose of this study is to test the safety of this novel cell, combination- based regenerative therapy for use in patients with symptomatic focal cartilage defects of the knee.
-
Utilization of Tonal Exercise System to Improve Short- and Long-term Low Back Pain (LBP) Outcomes (UTESISLLBPO)
Rochester, Minn.,
Minneapolis, Minn.
This study will assess the effect of incorporating a tonal exercise device into clinical and chiropractic care for lower back pain.
-
Validation of the PAKA (Patient Approved Knee Assessment) for Sports-Related Knee Surgery
Rochester, Minn.
The purpose of this study is to validate the patient approved knee assessment (PAKA) by providing the questionnaire to patients to assess patient needs, formulate a questionnaire based on this information, and finally validate the questionnaire in assessing the same outcomes as existing questionnaires for clinical use.
.