View clinical trials related to Compartment Syndrome.
Filter by:Chronic Compartment Syndrome (CCS) is a pathology that affects more specifically subjects exposed to repeated movements, particularly in a professional life or sports. The diagnosis is difficult and often delayed. Currently, the reference technique is invasive. It consists of measuring by a intramuscular puncture (IMP) pressure in the offending compartment early after effort (usually between 1 and 5 minutes post-exercise). A value greater than or equal to 30 mmHg in the first 5 minutes is used as a diagnostic criterion for CCS. Other less invasive techniques (scintigraphy) exist but are subject to certain discordances of interpretation. The advent of new assessment tools, like the MyotonPRO, pave the way for a non-invasive diagnostic approach.
Compartment syndrome (CS) is a condition resulting from increased pressure within a compartment, which compromises circulation and can lead to critical limb ischemia. CS is one of the biggest medical challenges that our soldiers face after battlefield related injuries. Chronic or exercise-induced compartment syndrome (CS)rarely requires treatment; acute compartment syndrome is a medical emergency requiring surgery. Treatment of compartment syndrome is limited to fasciotomy, which relieves the pressure.The study purpose is to evaluate the feasibility and safety of the administration of marrow-derived autologous bone marrow concentrate and PRP gel generated by a point of care marrow separation system for the treatment of compartment syndrome. And to show this treatment possibly enhances wound healing, bone healing, perfusion, infection control, and the return of limb function in patients with CS. Stem Cell and regenerative medicine development efforts for therapeutic angiogenesis and wound healing have predominantly focused on the mechanism of action of a single stem cell population to achieve neovascularization and improve tissue perfusion. It is well documented that other cells, including platelets, are efficient carriers of growth factors (VEGF-PDGF, bFGF, and SDF-1) and play active roles in angiogenesis and wound healing. Arteriocyte's development efforts focus on concentration of autologous bone marrow-derived stem cells and platelets for delivery to the site of injury in a concentration sufficient to effect local tissue revascularization and repair. These products provide for the rapid, bedside preparation of autologous PRP and bone marrow stem cell concentrate. This clinical trial with the Magellan® System is for the preparation of autologous cell concentrate for the treatment of wound, tissue and bone healing, improved perfusion, infection control, and the return of limb function in patients at risk of amputation.
The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time. We hypothesize that this technology, combined with vital signs, intracompartmental pressures and clinical examinations, will be useful in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS, and evaluating the adequacy of fasciotomy in patients treated for ACS.
This study aims to determine how infrared spectroscopy compares to continuous compartment pressure monitoring in the detection of compartment syndrome. Individuals meeting the study eligibility criteria will be identified at time of admission by the receiving Trauma and Orthopaedics Registrar who will be trained in the study design and protocols. Eligible individuals will be approached about participating in the study either at time of admission or shortly afterwards, either by the chief investigator or another doctor trained in the research protocol. Where the individual is unconscious or otherwise incapacitated, which is likely in many major trauma victims, inclusion in the study will be discussed with the patient's legal representative and/or family. The consent process for the study will consist of having the study protocol explained by either the chief investigator, or another doctor trained in the study design. Patients will be allowed to read a participant information sheet, and permitted as much time as they require to decide if they wish to participate in the study. Verbal and written consent will be taken using a study specific consent form. In the case of incapacitated patients, the study design will be explained to their relatives' legal representatives as appropriate and advice sought from them as to whether they know of any reason why the patient might object to participate in the study. Upon regain capacity consent will be sought from the patient for storage and analysis of their study data. Once consented, the patient will undergo monitoring with both continuous compartment pressures, and NIRS measurements. Recordings for both techniques will be taken each hour, as part of the patients normal observations, from the point of consent until 24 hours after their first operation. Where patients do not have an operation the total duration of monitoring will be 24 hours. The measurements will be taken by nursing staff who have received training in both techniques. The procedure for each technique is described below: 1. Continuous compartment pressures will be recorded in the broken leg, in case of tibial fractures, in all other patients fitting the inclusion criteria measurements will be taken from both legs (as both legs are at risk of compartment syndrome). Compartment pressures will be recorded using a slit catheter technique. Insertion of the slit catheter will be performed by either the chief investigator or Orthopaedic Registrar who will have been trained in the technique. The slit catheter is inserted using a sterile technique - the skin over the front outer part of the leg is cleaned and a catheter inserted into the anterior muscle compartment at this point. The catheter should be sited at the approximate midpoint of the leg, although this can be adjusted up or down if this would lead to insertion into a fracture site. The catheter is secured with a sterile dressing and connected to a monitor from which recordings can be taken, the catheter can be left in place for the duration of the study with no need to re-site it unless it stops recording accurately. At the same time as compartment pressure measurements are taken the patient's blood pressure will be monitored and the 'Perfusion Pressure' for the leg calculated, where: Perfusion pressure = diastolic blood pressure - leg compartment pressure 2. NIRS measurements will be taken with an the INVOS system, produced by Somentics. These measurements will be taken from both legs, the affected leg and other other leg used as a control for comparison. Where both legs are at risk measurements will be taken from both legs and the midpoint of the forearm used as a control. The INVOS probe is a small adhesive patch that is stuck to the skin. The probe is sterile and will be attached using the same sterile technique as the compartment pressure catheter. Where the overlying skin is hairy the hair overlying the area for the probe should be clipped before attaching the probe, to ensure adequate adhesion and accurate readings. The probe is to be sited just below the compartment pressure catheter, although if there is an underlying haematoma (blood clot), then the probe should be positioned so at to avoid this but still remaining over the front outer part of the leg. This technique conforms with the manufacturers recommended use of the equipment and is similar protocol to previous studies. At the end of the monitoring period both measuring devices are removed. If the patient has developed compartment syndrome during this period and required an operation, the NIRS probe and compartment pressure catheter will be replaced for a further 12 hours of monitoring to monitor the changes post-operatively and ensure compartment pressures stay low.
This study will test the safety of a new treatment method called tissue ultrafiltration. We will test this method in the treatment of compartment syndrome, a condition that occurs when pressure within the muscles builds to dangerous levels. In the legs and other parts of the body, a tough, stiff membrane covers groups of muscles and the nerves and blood vessels that run next to and through them. The entire unit is called a compartment. The causes of compartment syndrome include traumatic leg injuries and loss of blood supply. In tissue ultrafiltration, a doctor places hollow probes, or catheters, directly into the muscle compartment in the injured area of the lower leg. The probes remove fluid from the compartment (extra fluid can cause increased pressure). We will do an initial safety study in a group of patients who have had surgery for a broken tibia (the inner, larger bone of the lower leg) and are at high risk for developing compartment syndrome. The goals of this initial study are to show that inserting tissue ultrafiltration catheters in the muscle compartment is safe and can be done repeatedly without problems; to show that tissue ultrafiltration can be used to monitor the biochemical environment inside tissues; and to show that the catheter apparatus provides an accurate measurement of pressure in the compartment.