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Fractures, Closed clinical trials

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NCT ID: NCT06304649 Not yet recruiting - Fracture Clinical Trials

Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures

Cast21 SAP
Start date: April 2024
Phase: N/A
Study type: Interventional

The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients. A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product.

NCT ID: NCT06209242 Completed - Clinical trials for Closed Fracture of Lower End of Radius

Cast Immobilization Versus Percutaneous Pinning for Fracture of Radius in an Elderly Patient

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Distal radius fractures, particularly in elderly individuals, are a common problem associated with increasing age and hormonal changes. The choice of treatment, such as cast immobilization or percutaneous pinning, plays a crucial role in achieving optimal functional outcomes and facilitating a return to normal activities. This study aimed to compare the radiological and clinical outcomes of cast immobilization and percutaneous pinning in elderly patients with distal radius fractures.

NCT ID: NCT06130397 Recruiting - Fracture Clinical Trials

AI Assisted Detection of Fractures on X-Rays (FRACT-AI)

FRACT-AI
Start date: February 8, 2024
Phase:
Study type: Observational

This study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838). This work aims to evaluate the impact of an Artificial Intelligence (AI)-enhanced algorithm called Boneview on the diagnostic accuracy of clinicians in the detection of fractures on plain XR (X-Ray). The study will create a dataset of 500 plain X-Rays involving standard images of all bones other than the skull and cervical spine, with 50% normal cases and 50% containing fractures. A reference 'ground truth' for each image to confirm the presence or absence of a fracture will be established by a senior radiologist panel. This dataset will then be inferenced by the Gleamer Boneview algorithm to identify fractures. Performance of the algorithm will be compared against the reference standard. The study will then undertake a Multiple-Reader Multiple-Case study in which clinicians interpret all images without AI and then subsequently with access to the output of the AI algorithm. 18 clinicians will be recruited as readers with 3 from each of six distinct clinical groups: Emergency Medicine, Trauma and Orthopedic Surgery, Emergency Nurse Practitioners, Physiotherapy, Radiology and Radiographers, with three levels of seniority in each group. Changes in reporting accuracy (sensitivity, specificity), confidence, and speed of readers in two sessions will be compared. The results will be analyzed in a pooled analysis for all readers as well as for the following subgroups: Clinical role, Level of seniority, Pathological finding, Difficulty of image. The study will demonstrate the impact of an AI interpretation as compared with interpretation by clinicians, and as compared with clinicians using the AI as an adjunct to their interpretation. The study will represent a range of professional backgrounds and levels of experience among the clinical element. The study will use plain film x-rays that will represent a range of anatomical views and pathological presentations, however x-rays will present equal numbers of pathological and non-pathological x-rays, giving equal weight to assessment of specificity and sensitivity. Ethics approval has already been granted, and the study will be disseminated through publication in peer-reviewed journals and presentation at relevant conferences.

NCT ID: NCT05655130 Terminated - Fractures, Bone Clinical Trials

Distal Radius Steroid

Start date: November 6, 2018
Phase: Phase 1
Study type: Interventional

The primary goal of this study is to compare functional outcomes (range of motion [flexion, extension, supination, pronation], return to work, of patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. Secondary goals include comparison of pain control (number of pain pills consumed, visual analog scale (VAS) pain scores) between patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. The primary endpoint of this study will occur when 18 patients in each test-group complete the 6 month follow up visit for study.

NCT ID: NCT05525988 Active, not recruiting - Clinical trials for Closed Fracture Scaphoid, Proximal Pole

Proximal Pole Scaphoid Reconstruction Using Proximal Hamate

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

Recently, A novel surgical technique was illustrated by Elhassan BT et al. in 2016 utilizing the Hemi-hamate autograft for the reconstruction of scaphoid bone proximal pole non-union with avascular necrosis. The technique showed promising results but is still limited to case reports and anatomical studies In this study, we aim to: 1. Evaluate the surgical technique steps and suggest any possible modifications to the original description of the technique. 2. Assessment of clinical outcomes of this novel technique in terms of; bone union rate, time to union, and wrist function. 3. Report any complications of the usage of the proximal hamate for the proximal pole of the scaphoid reconstruction.

NCT ID: NCT05260463 Recruiting - Clinical trials for Surgical Site Infection

LOQTEQ® Antibacterial Pre-Market Study

Start date: December 9, 2021
Phase: N/A
Study type: Interventional

aap001 is a randomized, controlled, subject-blinded, multi-center study to show the safety of the LOQTEQ® antibacterial silver-coated system is non-inferior in comparison with the uncoated LOQTEQ® system

NCT ID: NCT05086224 Enrolling by invitation - Clinical trials for Distal Radius Fractures

Hematoma Block Versus Bier Block for Closed Fracture Reduction

Start date: July 15, 2021
Phase: Early Phase 1
Study type: Interventional

The investigators objective of this study is to evaluate the effectiveness of hematoma block versus intravenous regional anesthesia (Bier block) during closed reduction of distal radius fractures.

NCT ID: NCT04730739 Recruiting - Fracture Clinical Trials

FastFrame Knee Spanning and Damage Control Kit PMCF

Start date: June 18, 2021
Phase: N/A
Study type: Interventional

The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.

NCT ID: NCT04482205 Completed - Economic Burden Clinical Trials

Covid -19 Pandemic: Economic Burden on Patients Operated for Traumatic Close Fractures

Start date: March 16, 2020
Phase:
Study type: Observational

Covid-19 has adversely impacted the health care organizations by over burdening with Covid patients and suspending the elective surgeries and clinics A single center retrospective study was conducted to quantify losses due to postponement of elective surgeries and extra cost for procurement of PPEs. The secondary objective was to see the effect of Covid -19 on the total costs of inpatient care during Covid era.

NCT ID: NCT04274530 Recruiting - Pain, Postoperative Clinical Trials

Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial

COPE
Start date: January 25, 2021
Phase: N/A
Study type: Interventional

Psychological factors such as stress, distress, anxiety, depression, and poor coping strategies may be associated with ongoing pain following injuries such as fractures. To study this relationship, patients will undergo cognitive behavioural therapy (CBT) which is designed to modify such thoughts with the goal of reducing ongoing pain and improving quality of life. The goal of this study is to determine if CBT, versus usual care, reduces the prevalence of moderate to severe persistent post-surgical pain (PPSP) over 12-months post-fracture in patients with an open or closed fracture of the appendicular skeleton, treated with internal fixation.