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This study is a post-market follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (IFU).
This study is a post-market follow-up study to fulfil the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12/2 and the Medical Devices Regulation (MDR 2017/745). The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (IFU).
The objectives of the study are to calculate the overall clinical success rate and the performance, and confirm the safety of the JuggerStitch Meniscal Repair Device. The primary endpoint of this study is defined by the absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at one year.
Meniscus Tear, Tibial
JuggerStitch Meniscal Repair Device
Not yet recruiting
Published on BioPortfolio: 2020-01-21T11:32:36-0500
There are two cartilage structures in each knee joint called a meniscus. A torn meniscus can be caused by either a smaller or larger trauma or be a degenerative age-related tear. Arthrosco...
Meniscal repair resulting in meniscal preservation is the most desirable treatment of a torn meniscus and is one of the most commonly performed arthroscopic procedures. The inside-out men...
This is a retrospective study of meniscal tear repairs at least one-year post repair status. All patients were treated with Ceterix NovoStitch devices. The primary objectives of this study...
The menisci in the knee joint are important for normal functioning of the knee. Meniscus tears are amongst the commonest of injuries to the knee. The pattern and blood supply of the menisc...
The aim of this study is to evaluate and analyze the role of magnetic resonance imaging in the diagnosis of medial meniscal posterior root tears, including the normal variations in menisca...
The purpose of this study was to evaluate the healing rate of repaired meniscus and functional outcomes of patients who received all-inside meniscal repair using sutures or devices with concomitant ar...
: Meniscal injury and loss of meniscus tissue lead to osteoarthritis development. Therefore, novel biologic strategies are needed to enhance meniscus tissue repair. The purpose of this study was to id...
Meniscal tears are common knee injuries that occur in different populations and particularly among athletes. Either isolated or accompanied with anterior cruciate ligament injury, meniscal tears can b...
One of the factors affecting the healing of a meniscus repair is the primary stability of the tear. The purpose of this study is to compare single and double vertical loop (SVL vs. DVL) meniscal sutur...
The efficacy and outcomes for the concurrent repair of medial meniscus posterior horn root tear (MMPHRT) during open wedge high tibial osteotomy (OWHTO) are unclear. This study compared the radiologic...
Injuries to the TIBIAL MENISCUS of the leg.
The tear-forming and tear-conducting system which includes the lacrimal glands, eyelid margins, conjunctival sac, and the tear drainage system.
Disease of the TIBIAL NERVE (also referred to as the posterior tibial nerve). The most commonly associated condition is the TARSAL TUNNEL SYNDROME. However, LEG INJURIES; ISCHEMIA; and inflammatory conditions (e.g., COLLAGEN DISEASES) may also affect the nerve. Clinical features include PARALYSIS of plantar flexion, ankle inversion and toe flexion as well as loss of sensation over the sole of the foot. (From Joynt, Clinical Neurology, 1995, Ch51, p32)
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
The reconstruction of a continuous two-stranded DNA molecule without mismatch from a molecule which contained damaged regions. The major repair mechanisms are excision repair, in which defective regions in one strand are excised and resynthesized using the complementary base pairing information in the intact strand; photoreactivation repair, in which the lethal and mutagenic effects of ultraviolet light are eliminated; and post-replication repair, in which the primary lesions are not repaired, but the gaps in one daughter duplex are filled in by incorporation of portions of the other (undamaged) daughter duplex. Excision repair and post-replication repair are sometimes referred to as "dark repair" because they do not require light.
The role of medical devices in healthcare is essential. The diversity and innovativeness of this sector contribute significantly to enhance the quality and efficacy of healthcare. Covering a wide range of products, from simple bandages to the...