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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Minimally invasive surgery has greatly changed surgical practices since the 1980s, especially in urology where laparoscopy and robot-assisted surgery have advanced treatment of conditions like prostate cancer. In France and other countries, robotic surgery became widespread without strong studies confirming its benefits or guidelines on quality and access. This trial aims to carefully evaluate robot-assisted prostate removal compared to traditional laparoscopic and open surgery techniques to provide clear evidence for patients and healthcare decision-makers. Participants will undergo radical prostatectomy using one of three approaches: robot-assisted laparoscopy, conventional laparoscopy, or open surgery (laparotomy). Urinary and erectile functions will be assessed before and after surgery to compare outcomes across the three groups. This large prospective study is conducted at multiple centers to gather reliable data on the benefits and impacts of each surgical method. During the study, patients will be evaluated for urinary function using the EPIC 50 score 45 days after surgery. Researchers will also assess erectile and urinary functions before and after the prostatectomy. The study focuses on understanding how each surgical technique affects recovery and function, helping to inform patients and health authorities about the real advantages of robot-assisted surgery. Participants must be hospitalized for planned radical prostatectomy and will be monitored throughout their treatment and recovery.
Actively Recruiting
Researchers are evaluating the performance and safety of the FHK4-CK knee prosthesis, designed for patients needing complex primary or revision knee arthroplasty due to gonarthrosis. This new medical device complements an existing first-line prosthesis range and aims to offer surgeons a versatile and reliable option for restoring mobility and quality of life. The study is a pilot with a follow-up period of two years to assess outcomes after implantation. The FHK4-CK prosthesis is a class III device that will be implanted using specialized instruments and surgical techniques defined by the manufacturer. It is intended for patients with major axial deviation, peripheral failure, or bone defects requiring either first-time arthroplasty or revision after failure of an earlier implant. The device and associated procedures are designed to simplify surgery, improve compatibility with existing prostheses, and reduce risks. Participants will undergo functional performance assessments before surgery and at 6 weeks, 6 months, 12 months, and 24 months post-surgery. During the study, patients will complete questionnaires and be monitored for safety and prosthetic function. The study requires informed consent, health insurance coverage, and the ability to participate in follow-up visits over two years to evaluate the device's effectiveness and safety.
Actively Recruiting
This research aims to evaluate the safety and performance of the SYMBOL range of medical devices used in total hip arthroplasty (THA) procedures. It focuses on patients undergoing either primary or revision total hip replacements due to various hip conditions, including degenerative hip joint disease, post-traumatic osteoarthritis, hip arthritis, femoral neck fractures, avascular necrosis of the femoral head, or failure of previous joint implants. The study will follow patients for a period of 10 years to assess long-term outcomes. Participants will receive total hip arthroplasty using at least one medical device from the SYMBOL range. The study monitors the survivorship of 13 individual SYMBOL orthopedic components over the 10 years following surgery. Both primary and revision hip replacement procedures are included, and the devices used are those manufactured by DEDIENNE Santé under the SYMBOL range. During the study, patients will be regularly assessed to monitor the performance and safety of the implanted devices. Researchers will track the longevity of the implants and watch for any complications or failures. Participants must be able to read, write, and understand French and will provide informed consent. The study excludes those unable to follow procedures or who have previously participated with a SYMBOL device. The total duration of participation is 10 years post-operation, allowing comprehensive long-term monitoring.
Actively Recruiting
Rotator cuff injuries are common, affecting about 30% of the general population. When initial rotator cuff repair does not heal properly, patients may continue to experience pain. During revision surgery, bacteria can be found in about 30% of cases without clear infection symptoms, called unexpected positive cultures (UPC). The impact of UPC on healing and outcomes after rotator cuff revision surgery is not well understood, and there is no consensus on how to manage these cases, especially regarding antibiotic use. This study will prospectively compare patients undergoing rotator cuff revision surgery who have either positive or negative bacteria cultures from samples taken during their surgery. The research involves collecting normally discarded samples such as sutures, tendon debridement tissue, and cleaning products for bacteriological analysis. Antibiotic treatment will not be started immediately after surgery or during the first month unless a pathogenic microorganism is identified, in which case antibiotics will be given and the patient will stop the study. Participants will be followed and assessed at 1 month, 3 months, 6 months, and 1 year after surgery. Researchers will evaluate shoulder function, tendon healing, post-operative complications, and other functional scores over this time. They will also describe the types of bacteria found in positive cultures. The study aims to better understand the effect of unexpected positive cultures on recovery and healing after rotator cuff revision.