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Radius Fractures clinical trials

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NCT ID: NCT06313489 Active, not recruiting - Pathology Clinical Trials

Rupture of Thumb's Long Extensor Tendon After Fracture of the Distal Radius, Study of Muscle and Tendon Pathology

Start date: February 1, 2023
Phase:
Study type: Observational

Fractures of the wrist (fractures of the distal radius) are one of the most common fractures with almost 60 000 injuries per year in Sweden. One known complication following these fractures is that the long extensor tendon of the thumb ruptures (extensor pollicis longus tendon, EPL tendon). This leads to disability to stretch the thumb in order to grip bigger objects. Earlier studies show that the tendon ruptures in about 3-5% of all wrist fractures. These ruptures occur some weeks to months after the fracture. There are different theories about the cause of the rupture. One theory is that the fracture creates a bleeding in the tight area that the tendon lies, leading to high pressure and therefore low blood supply to the tendon. Another theory is that the tendon comes in contact with some sharp bonny fragments in this area that injures the tendon when it moves. Such tendon ruptures need almost always some type of surgical intervention in order to reconstruct the function of the thumb. A common problem is that the quality of the tendon is insufficient for just suturing it. Another problem is that the muscle becomes stiff after the rupture. However, there is no objective method to determine how stiff the muscle is. The most common treatment option is the transfer of one of the two extensor tendons of the index finger to the thumb, a so-called extensor indicis proprius to extensor pollicis longus transfer. The motivation behind this operation is that the muscle of EPL is so stiff that cannot be used to lift the thumb. However, there is no consensus about the time period after which the EPL muscle can be used to reconstruct the function of thumb. The study aims to investigate the microscopical changes in the muscle and tendon of EPL after such a rupture. Better knowledge of these factors could lead to better understanding of the treatment options. The investigators plan to include in the study all patients that would get operated for an EPL tendon rupture after a fracture of the distal radius at the institution the study is conducted. After oral and written information to the patient and written consent the investigators will take some samples from the ruptured tendon and muscle for microscopical analysis.

NCT ID: NCT06067074 Active, not recruiting - Quality of Life Clinical Trials

Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture

HE-VOCAL
Start date: February 8, 2022
Phase: N/A
Study type: Interventional

A cost-utility analysis based on an earlier published RCT comparing surgery with volar locking plate to non-operative treatment for the elderly with a displaced distal radius fracture.

NCT ID: NCT05987033 Active, not recruiting - Clinical trials for Distal Radius Fractures

Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.

Start date: August 9, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from distal radius fracture. NVDX3 will be implanted during a single surgical intervention.

NCT ID: NCT05722808 Active, not recruiting - Clinical trials for Distal Radius Fracture

What is the Rate of Surgical Treatment in Adult Patients With Displaced Distal Radius Fractures Managed According to the Danish National Clinical Practice Guidelines? - A Single Center Retrospective Cohort Study

Start date: January 1, 2018
Phase:
Study type: Observational

Through this study we aim to investigate the rate of DRFs initially treated with successful closed reduction (to an acceptable position, then immobilized in a plaster cast), that re-displace and end up requiring surgery. This study will clarify the incidence of DRFs where surgical intervention could potentially be avoided if the initial closed reduction lasted until sufficient bone healing was attained. As DRFs are the most common fracture of the adult population treated in the Danish emergency departments, the aim of this study is to examine the amount of people with DRFs that could potentially avoid surgery and thereby lowering the cost to the health care system, as well as save the patient invasive surgery. Furthermore, we expect to classify which specific types of fractures according to Arbeitsgemeinschaft für Osteosynthesefragen/ Orthopaedic Trauma Association (AO/OTA) classification system have a high or low incidence of secondary surgery after primary closed reduction.

NCT ID: NCT05716438 Active, not recruiting - Clinical trials for Distal Radius Fracture

Prospective Evaluation of Cast Bivalving for Pediatric Distal Radius Fractures

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

Pediatric patients with distal radius fractures are most commonly treated non-operatively with fracture reduction and cast immobilization. In order to prevent complications from increased swelling after the injury (or fracture manipulation) casts may be split along their length to relieve pressure. However, this can compromise the casts' structural integrity, predisposing fractures to loss of reduction. The goal of this study was to investigate if cast bivalving, or splitting the cast longitudinally on both sides, resulted in any immediate change to bony alignment and to assess if bivalving effected cast parameters associated with loss of reduction.

NCT ID: NCT04716309 Active, not recruiting - Clinical trials for Distal Radius Fractures

Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP).

Start date: February 16, 2021
Phase: N/A
Study type: Interventional

120 patients age 18-64 years with dorsally displaced distal radius fractures AO-type A2, A3 and C1 are recruited from Oslo Casualty Medical Centre (Oslo Skadelegevakt). Patients are randomized to surgery with closed reduction and pins (CRPP) or open reduction and volar locking plate (VLP). The hypotheses is that CRPP will give equal function and satisfaction to VLP. Patients are followed by current practice of follow-ups until 5 weeks postoperatively, and in addition due to the study with functional tests after 2, 3, 6 and 12 months. These follow-ups will be performed by hand therapist. Scores are also recorded from Patient-Reported Wrist and Hand Evaluation (PRWHE), Quick-Dash (Q-d) and EuroQol Questionnaire (EQ-5D) questionnaires. The main efficacy measure in the study is PRWHE scores after 12 months. There will be X-ray initially, postoperatively and after 12 months. Sub-objectives in the study are analyses of cost-effectiveness (measured by EQ 5D, personnel use, use of additional healthcare service and absence from work), and differences in complications between the two methods.

NCT ID: NCT04653051 Active, not recruiting - Clinical trials for Distal Radius Fracture

PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System

Start date: March 12, 2021
Phase:
Study type: Observational

The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objective is the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events.

NCT ID: NCT03349216 Active, not recruiting - Clinical trials for Distal Radius Fracture

Bier's Block Versus Systemic Analgesia

Start date: October 20, 2017
Phase: Phase 2
Study type: Interventional

Background: There are three methods for procedural sedation in upper extremity traumas; systemic, regional and local anesthesia. There is controversy in the literature regarding the method of choice for this purpose. Objectives: The aim of this study was to compare conscious sedation and Bier's block methods for pain reduction in upper extremity trauma patients. Patients and Methods: This was a randomized clinical trial. Patients were randomly allocated to either the Bier's block or the conscious sedation group. Pain reduction was assessed by a numerical rating scale; patients, surgeons and physicians responsible for analgesia satisfaction were assessed using a five-point Likert scale. In this study, we aimed to compare the effectiveness, complications, duration, hemodynamic stability and patient and physician satisfaction between systemic analgesia and Bier's block method performed at the emergency department.

NCT ID: NCT03076034 Active, not recruiting - Osteoporosis Clinical Trials

Utility of Cortical Bone Tissue Properties in the Assessment of Fracture Risk

Start date: January 26, 2015
Phase: N/A
Study type: Interventional

The objective of this study is to determine whether a new minimally invasive method for in vivo measurement of cortical bone tissue properties can identify those who are at risk for fragility fractures of the hip and radius. The investigators hypothesis is that women with fragility fractures of the hip and radius have altered cortical bone tissue properties compared to non-fracture controls independent of standard clinical tests, such as bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA).

NCT ID: NCT02336035 Active, not recruiting - Clinical trials for Distal Radius Fracture

Distal Radius Fractures in Patients Over 65 Years, Operation or Cast?

DROC
Start date: January 2015
Phase: N/A
Study type: Interventional

Eligible patients that sign an informed consent will be randomized to operation with volar locking plate or cast immobilization. Primary follow-up after 1 year.