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Proximal Humeral Fracture clinical trials

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NCT ID: NCT04762667 Recruiting - Clinical trials for Proximal Humeral Fracture

Individual Preoperative Planning for RSA

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04748016 Recruiting - Clinical trials for Proximal Humeral Fracture

3D-printed Bone Models in Addition to CT Imaging for Intra-articular Fracture Repair

SPRINT
Start date: March 13, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effectiveness of 3D-printed bone models in addition to CT imaging versus CT imaging alone on surgical quality and operation time for patients undergoing surgical repair of intra-articular fractures.

NCT ID: NCT04675879 Completed - Clinical trials for Proximal Humeral Fracture

Clinical and Radiological Results of Conservative Treatments in Proximal Humerus Fractures.

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

In the investigators' prospective randomized study, the investigator will investigate the effect of different bandage types on functional and radiological results of proximal humerus fractures over 18 years of age, for whom conservative treatment is decided. In recent studies, it has been shown that surgical treatment in proximal humerus fractures has a high complication rate and is also not superior to conservative treatments in terms of functional results. Therefore, the importance of conservative treatment is increasing day by day in this group of fractures, especially in elderly patients with high risk for surgery. In these studies in the literature, the method in conservative treatment is not clearly specified, and the investigator will apply 3 different bandages to adjust the rotation of the shoulder in 3 different ways during the investigators' conservative treatment. The investigator will compare functional and radiological results between these groups.

NCT ID: NCT04623346 Active, not recruiting - Ankle Fractures Clinical Trials

Orthopaedic Conservative Treatment in the Time of Covid-19 Pandemic

Start date: March 11, 2020
Phase:
Study type: Observational

This is a one centered retrospective study. Tendency for surgical interventions in the pre-pandemic period was reduced to protect surgical team and patients. The investigators aimed to find out the answer to the following question: will conservative treatment be the shining star in the post pandemic period?

NCT ID: NCT04622852 Completed - Clinical trials for Implant Complication

Pegs for Osteofixation of Proximal Humeral Fractures

Start date: July 1, 2017
Phase:
Study type: Observational

Patients treated operative for Proximal humeral fractures with angular stable device (Philos plate or ALPS-PHP)

NCT ID: NCT04543682 Recruiting - Clinical trials for Proximal Humeral Fracture

A Clinical Trial Investigating Iloprost as Medication to Improve Bone Healing in Patients With Proximal Humeral Fracture

Ilobone
Start date: May 12, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The main objective of this study is to establish the safety as well as the efficacy of local insertion of Iloprost at the fracture site for bone healing of the proximal humeral fracture. The study will have two treatment groups and one control group. All patients will receive the standard of care procedure (reduction and angular stable (PHILOS) plate fixation). The two treatment groups will additionally be treated with two different Iloprost doses. Subjects will be assessed for study eligibility within 24h after admission (screening period). Eligible subjects will be assessed for baseline parameters on day 0. Within 96 hours of the study, subjects will undergo surgery, reduction, and angular stable (PHILOS) plate fixation. During the procedure, a catheter will be inserted in the fracture site of the treatment groups in order to deliver the Iloprost locally in the fracture site. The expected total duration of study participation for each subject comprises 52 weeks, among which 26 weeks include active study participation. At the study end, a telephone call with the subjects will be performed for safety assessment. Recruitment will be completed in approximately 18 months. Follow up visits following the surgical operation shall take place during weeks 3, 6, 12, and 26. The last follow-up will be a phone call during week 52 for the purpose of safety assessment.

NCT ID: NCT04523415 Recruiting - Clinical trials for Proximal Humeral Fracture

Researches About Proximal Humerus Fractures

Start date: January 1, 2019
Phase:
Study type: Observational

Majority of previous classifications based on two-dimensional images to analyze these complicated 3-D fractures. Small or delicate changes in rotation and positioning can result to considerable disagreement in the interpretation of standard radiographs. Therefore, a classification system which had a better reliability and reproducibility for the fractures is warranted and helpful for orthopedic surgeons. Furthermore, CT and 3-D CT construction images with high resolution give a much clearer view of the pattern of proximal humeral fractures. Edelson proposed a new three-dimensional classification for fractures of the proximal humerus. The results concluded that it was a useful in classifying these injuries with reasonable interobserver reliability. It could be hypothesized that patients with proximal humeral fractures would benefit from this 3D classification, but there is a scarcity of application of the classification in large samples. T

NCT ID: NCT04056351 Completed - Clinical trials for Proximal Humeral Fracture

A Research Study to Understand and Predict the Failure of Shoulder Fracture Fixations Using Computer Simulations

PHILOS-SIM
Start date: August 2, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03919422 Completed - Clinical trials for Proximal Humeral Fracture

Paravertebral Block for Proximal Humeral Fracture Surgery

Start date: May 5, 2019
Phase: N/A
Study type: Interventional

This study evaluates the effects of T2 paravertebral block block improving interscalene brachial plexus block and superficial cervical plexus block on the relief of pain intensity during elderly proximal humerus fracture fixation surgery. The brachial plexus and cervical plexus block(IC block) will be performed in half of participants, while the T2 paravertebral block combined with IC block will be performed in the other half.

NCT ID: NCT03786679 Recruiting - Clinical trials for Proximal Humeral Fracture

Non-operative Treatment in Sweden of Proximal Humeral Fractures

NOSWEPH
Start date: February 25, 2019
Phase: N/A
Study type: Interventional

Proximal humeral fractures are common especially in the elderly population. The majority of these fractures are minimally displaced and may be treated non-operatively. There is however a controversy about which fractures that need surgery and randomised trials have not been able to show a clinically important advantage in patient reported outcome measures for those operated. The trend is therefore that also displaced and comminute fractures are treated non-operatively. There is however very little scientific support for how the non-operative treatment should be designed and performed. Therefore this prospective multicenter study is aiming at investigating the benefit of a four week immobilisation orthosis as compared to early range of motion exercises for those patients not assigned for surgery one week after the trauma.