Active clinical trials for "Shoulder Fractures"

To investigate the assumption that reversed shoulder prosthetic replacement will give a better functional outcome compared to open reduction and internal fixation with an angular stable plate in displaced proximal humeral fractures. Short name: The DelPhi trial.

The hypothesis of this study is to determine whether the technique of intramedullary locking nail presents clinical results comparable to the technique of locking plates, based on the Constant Score.

Fractures of the shoulder, the so-called proximal humeral fractures, can be treated with locking plates that have shown good results in clinical practice, but complications can occur. In order to further improve the treatment of proximal humerus fractures and decrease the rate of fixation failures, further research is necessary. As a first step, the reasons for potential implant failures need to be understood. This study has been initiated by scientists at the AO Research Institute Davos (ARI), Switzerland, which is the research center of the AO Foundation (www.aofoundation.org), an international non-profit organization led by surgeons specialized in fractures such as these. Researchers at the ARI have been developing a computational simulation tool to predict fixation failure and demonstrated its efficiency in laboratory conditions. This clinical study has been organised to validate this tool using patient data, by comparing the risk of mechanical failure predicted by the computer simulated model with the clinically observed fixation failure. In future, this computer simulation tool is expected to help surgeons to select the best fixation for a given patient and to develop improved implants.

The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture healing in postmenopausal women with fractures of the hip or shoulder.

Proximal humeral fractures are with an incidence of 4-5% the third most common fractures in the elderly. Compared to fractures of the upper limb it is the second most common fracture after distal radial fractures. 65% of all patients with a proximal humeral fracture are older than 60 years. Being aware of the demographic change there will even be an increase of incidence of these fractures. Kannus et al. showed an incidence of 298 per 100,000 in the at least 80 years old patients in 2007. Palvanen et al. predict an increase of incidence of 50% until 2030. Approximately 80% of all humeral fractures are minimally or non-displaced and can be treated conservatively with a good functional result. In 20% of humeral fractures there is an indication for surgical treatment according to the modified Neer-Criteria. These criteria are fulfilled if there is an angulation of at least 45 degrees between fracture fragments, a displacement of the humeral shaft against the humeral head of at least 1 cm or a dislocation of the tuberculum of at least 5 mm. Up to now there is evidence for superiority of any surgical treatment in literature. At the moment the most frequently used surgical technique for treatment of proximal humeral fractures is the angle stable plate fixation. There are various publications concerning this topic published by the investigators research group. In their 10-years results a majority of patients showed excellent and good, but also 16% showed unsatisfactory results after locking plate fixation. Main risk for poor outcome was revision surgery caused by secondary displacement (14%) which is also confirmed by results of other studies. In a further study investigators could show that there is a higher risk for secondary displacement in 2-part-fractures with a gross primary dislocation or a large metaphyseal fracture zone (AO 11-A3), especially in osteoporotic patients. More over these are common fractures and because of that a problem in surgical treatment. A secondary varus dislocation of the head fragment and cutting-out are the most common complications of angle stable locking plates in AO 11-A3 fractures of the elderly. The primary reason for this mechanism of failure is certain instability of transmetaphyseal fractures in the region of the surgical neck caused by loss of impaction in a porous spongiosa. Because of that the forces on the head screws are high while the so called screw-bone-interface is rather weak after a surgical treatment. Currently there exist various approaches to avoid a failure of the primary screw implantation. One possibility to increase the stability of the screw-bone-interface is the cement augmentation of the screw tips. To date there exist no clinical study that reports the results of locking plate fixation and the augmentation of cannulated head screws although it is a widely used method in everyday surgery, especially in the elderly. A second possibility to prevent secondary displacement after surgical treatment of 2-fragment-fractures is the use of an intramedullary nails. A further development of intramedullary nails is multiplanar nailing. Screws can be inserted in various different levels and directions which can lead to a clearly higher stability. A comparison of these two treatment options augmented locking plate versus multiplanar angle stable locking nail in 2-part proximal humeral fractures has not been carried out up to now.

The Conventus CAGE™ PH (PH Cage) System Post-Approval Observational Data Collection Study (Study) is a single center, prospective, post-approval clinical study designed to collect device and procedure experience in everyday clinical practice.

Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making. The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and non-surgical management, 2) compare the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus impacted' and 'classical' four-part fracture patterns. The investigators will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two year period. Patients will be randomised to non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy. Patients will be followed at least one year and will be assessed blindly according to a standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score, and Short Form-36.

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty.

Degenerative diseases and traumatic injuries of the shoulder joint, lead to dysfunction of the arm. Arthroplasty has recently become an increasingly popular operation for severe damage to the shoulder joint. In clinical practice, the most effective operation today is the reverse shoulder arthroplasty (RSA), after the installation of which the pain syndrome disappears in patients and a satisfactory range of motion in the shoulder joint resumes. With the increasing use of reverse shoulder arthroplasty and its expanding indications, surgeons today are facing tougher reconstructive challenges while still providing the patient with a good clinical outcome. The damaged joint presents a problem for the surgeon during component positioning. Implants must place the in a location and orientation that optimizes range of motion and stability while minimizing impingement. In order to address this, surgeons can look to the use of 3D imaging in order to better understand each patient's pathology. All patients are performed computed tomography scans (CT) of the shoulder joint. Then, were reconstructed 3D model. To determine the position of the components is mounted a scapular plane was created based on 3 points on the 3D reconstructed scapula: center of the glenoid fossa, most medial point on the spinal border of the scapula, and most distal point on the inferior angle of the scapula. The investigators use a scapular plane for to determine the optimal angles of inclination of the reverse baseplate. Then the position and direction of the pilot pin is determined. The position of the fixing screws and their length are also calculated. A resection line is planned for the humerus. Preoperative virtual templating can be used to translate the preoperative plan into the operating suite in the form of patient specific instrumentation (PSI) and intraoperative navigation. PSI to reference the local anatomy in order to place the guide pin in the desired location, version, and inclination based on the preoperative plan. After surgery, all patients undergo a CT scan of the shoulder joint. These data are compared with CT scan of patients operated on according to the standard method. The range of motion is also assessed and compared.

The purpose of this study is to collect device and procedure experience in everyday clinical practice. The patients are being asked to participate in this study because they are a surgical candidate for the treatment of a broken shoulder and are considering treatment with the PH Cage device.