17 Clinical Trials for Various Conditions
Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a historical control arm (microfracture) in the treatment of cartilage defects in the knee.
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.
The purpose of this study is to assess the potential benefit of enhancing knee surgery for cartilage injury using some of the patient's own cells, taken from fat tissue, that may be able to help cartilage to regenerate.
The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of patients aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.
The purpose of this study is to compare two biologic methods for the treatment of articular cartilage defects in the knee. The first method, microfracture, is the standard of care and is routinely used to recruit cells from the subchondral bone marrow to the site of cartilage loss. The second method is the application of adipose-derived stem cells (ADSCs) to the defect site. In theory, ADSCs on a collagen scaffold should enable the delivery of more specific progenitor cells to the site of injury, resulting in better regeneration and integration of articular cartilage at the site of a defect as compared to the microfracture method.
The purpose of this study is to determine whether CARTISTEM, a cell therapeutic product, is safe and effective in the treatment of articular cartilage defects of the knee as a result of ageing, trauma, or degenerative diseases.
ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to microfracture treatment.
The purpose of this study is to evaluate the long-term outcomes of DeNovo NT, a tissue product used for the repair of cartilage damage in the knee. This product has been on the market since 2007 and implanted in more than 10,000 patients around the country.
HST003 is a human extracellular matrix designed for injection into the subchondral bone following microfracture surgery by an injection into the interstices created by the surgical awl and filling the full defect to help restore-regenerate hyaline cartilage to a pre-injury state. In this Phase 1/2 clinical trial, we will be addressing the knee joint in conjunction with microfracture surgery. HST003 is human extracellular matrix secreted by human dermal fibroblasts under hypoxic conditions. The various matrix proteins produce a combination structural scaffold in addition to the natural secreted glycoproteins such as lubricin, fibronectin, laminins, hyaluronic acid, and collagens - all critical components of cartilage, particularly hyaline cartilage. This Phase 1/2 study will help design additional studies to support FDA approval for the use of HST003 in focal cartilage defects in the knee resulting from recent traumatic injury.
Subjects will be selected among the investigators' patient population who are already scheduled to receive a marrow stimulating procedure (MSP), with or without the addition of BioCartilage. During the surgical operation for MSP, a portion of the patient's blood is taken out and used to form a patch to cover a cartilage defect of the knee. Currently it is considered standard of care to either form the patch using only a portion of the patient's blood, or form the patch using a portion of the patient's blood combined with an FDA-approved augmentation such as BioCartilage. This study will collect outcomes data and MRI for patients that are undergoing MSP with and without BioCartilage augmentation, then compare the data between those who received BioCartilage and those who did not. The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (measured using quality of life indicators, functional outcomes, and MRI) compared to subjects who receive MSP without the use of BioCartilage.
The goal of this randomized controlled clinical trial is to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for the treatment of cartilage defects of the distal femur in adult patients with knee pain and symptoms who are candidates for surgical intervention of the knee compared to outcomes for the control group. The primary effectiveness endpoint is Month 24 composite clinical success (CCS) defined by: * no secondary surgical intervention (SSI) and * an improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points. Researchers will compare the CCS for the investigational device group to a control group receiving the standard of care, either microfracture or debridement). Subjects randomized to the investigational group will receive the BioPoly Knee device and those randomized to the control group will receive the current standard of care, either microfracture or debridement.
The purpose of this study is to evaluate the safety and efficacy of Hyalofast® scaffold with bone marrow aspirate concentrate (BMAC) compared to microfracture in the treatment of symptomatic cartilage defects of the knee.
The purpose of this study is to evaluate the long-term relief of pain and return to function for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed product and has been used in more than 7,500 patients over the last 7 years.
The Cartilage Autograft Implantation System (CAIS) is designed as a single surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region. CAIS is indicated for the repair of articular cartilage lesions and osteochondritis dissecans (OCD) of the knee through cartilage regeneration.
The overall study objective is to evaluate Chondrofix Osteochondral Allograft ("Chondrofix") for the repair of osteochondral lesions in the knee. This includes, but is not limited to primary cartilage lesion repair and revision of failed prior cartilage repair treatments. The study hypothesis is that Chondrofix Allograft will provide pain relief and functional improvement as demonstrated by a comparative analysis of baseline clinical evaluations at 24 months of follow-up.
Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee
The purpose of this study is to evaluate changes in clinical and imaging outcomes following arthroscopic treatment of a single medial femoral chondral lesion plus partial medial meniscectomy by Radiofrequency-Based debridement or Mechanical Debridement in subjects ≥ eighteen (18) years of age.