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Proximal Humeral Fracture clinical trials

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NCT ID: NCT06133920 Recruiting - Clinical trials for Proximal Humeral Fracture

Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures

Start date: February 24, 2021
Phase:
Study type: Observational

The purpose of this study is to evaluate compare postoperative range of motion in patients who are given a sling for comfort only and allowed to start early active range of motion compared to patients who are placed in a sling for 4 weeks with passive range of motion only. Once enrolled, the patients will be randomized through computer randomization then placed in paper packets into either the immobilization group or the early range of motion group.

NCT ID: NCT06062797 Recruiting - Ankle Fractures Clinical Trials

Improving Patient Understanding in Preoperative Informed Consent Process of Trauma Patients Using a Mixed Reality Viewer

Start date: April 18, 2023
Phase: N/A
Study type: Interventional

This clinical trial aims to compare a Mixed Reality Viewer in the preoperative informed consent process to standard fracture visualization. The participants population are patients with an indication for surgery of a distal radius fracture, upper ankle fracture or proximal humerus fracture using plate osteosynthesis. The main questions aim to answer are: - Does the use of the Mixed Reality Viewer improve patient understanding? - Does the use of the Mixed Reality Viewer improve patient satisfaction? - Does the use of the Mixed Reality Viewer reduce patient preoperative anxiety? Participants will have their fracture presented via the Mixed Reality Viewer. Researchers will compare standard fracture imaging using X-ray or CT scans to see if there is any difference in understanding, satisfaction and anxiety.

NCT ID: NCT05703958 Recruiting - Clinical trials for Proximal Humeral Fracture

Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up

Start date: April 19, 2023
Phase:
Study type: Observational

The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This study will follow subjects for a period of up to 10 years post-surgery.

NCT ID: NCT05437822 Recruiting - Clinical trials for Proximal Humeral Fracture

Tranexamic Acid in Proximal Humeral Fractures

Start date: June 29, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the effect of tranexamic acid (on blood loss and transfusion requirements in patients with proximal humeral fractures requiring open surgical approaches. This a blinded, controlled, therapeutic trial in which the patients will be randomized to receive TXA or no drug intervention. The primary outcome is the estimated total blood loss. This study presents only minimal risks for the included patients.

NCT ID: NCT05002959 Recruiting - Clinical trials for Rheumatoid Arthritis

TESS V3 Modular Total Shoulder System PMCF

Start date: February 1, 2022
Phase:
Study type: Observational

This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and Reverse Modular Total shoulder prosthesis and its instrumentation.

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: 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: 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.