Wrist Fracture Clinical Trial
Official title:
Post-Market Clinical Follow-Up Study to Provide Safety, Performance and Clinical Benefits Data of the XtraFix® Small External Fixation System (Implants and Instrumentation) - A Retrospective Consecutive Series Study
The study is a monocentric, 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 XtraFix® Small External Fixation System (implants and instrumentation) when used to treat long bone fractures. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Subjects' outcomes will also be assessed.
The XtraFix® Small External Fixation System is intended to be used for the treatment of appropriately sized long bone fractures (in foot, arm, wrist and hand), which account for 20% of all fractures in emergency departments and are the most common fractures in all patients under the age of 75. In this study we will only collect data on wrist and proximal humerus fractures. One site will be involved in this study. The aim is to include a maximum of 91 consecutive series cases who received the XtraFix® Small External Fixation System at the Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" (Naples, Italy) starting from 2019 until 2021. All potential study subjects will be required to participate in the Informed Consent Process. Baseline data from the preoperative, intraoperative, immediate post-operative and device removal visit will be available in medical notes and collected retrospectively. During a follow up phone call at least 1 year post-operative the subject will be asked to complete a patient questionnaire and a clinical assessment of the fracture healing will be done. In addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected over the phone. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04046744 -
Axillary Block in Association With Analgesic Truncal Blocks at the Elbow for Wrist Surgery.
|
N/A | |
Completed |
NCT05883410 -
The Effect of Two Different Protocol in Wrist Joint Limitation After Distal Radius End Fractures
|
N/A | |
Terminated |
NCT02464280 -
Tomosynthesis of Pathologies of the Chest and Skeletal Structures in Comparison to CT
|
||
Not yet recruiting |
NCT03937492 -
EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY
|
N/A | |
Active, not recruiting |
NCT04623346 -
Orthopaedic Conservative Treatment in the Time of Covid-19 Pandemic
|
||
Completed |
NCT02802358 -
Evaluation of Health and Social Interventions Aimed to Old People Discharged From Hospital After a Hip or Wrist Fracture Due to a Fall
|
N/A | |
Completed |
NCT03649542 -
The Effects of Fluidotherapy® Exercise
|
N/A | |
Not yet recruiting |
NCT03316768 -
Measurement of Grip and Pinch Forces Needed for Activities of Daily Living, Work and Prehistoric Stone Tool Production
|
||
Completed |
NCT02015468 -
The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating
|
N/A | |
Active, not recruiting |
NCT06067074 -
Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture
|
N/A | |
Terminated |
NCT01293227 -
WRx Distal Radius Wrist Fracture Study
|
N/A | |
Completed |
NCT03126474 -
Defining Displacement Thresholds for Surgical Intervention for Distal Radius Fractures - a Delphi Study
|
||
Active, not recruiting |
NCT04716309 -
Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP).
|
N/A | |
Completed |
NCT02693288 -
Comparing Efficacity of Analgesia Between Ultrasound-guided Nerve Block and Local Infiltration After Wrist Fracture Surgery
|
N/A | |
Active, not recruiting |
NCT01268397 -
Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly
|
N/A | |
Recruiting |
NCT05183477 -
Fast Track for Wrist and Scaphoid Fractures
|
N/A | |
Withdrawn |
NCT04527588 -
Italian Translation of the Michigan Hand Outcomes Questionnaire
|
||
Completed |
NCT03555929 -
Impact on Sensitivity and Motor Block Duration of an Intravenous Dexamethasone an Axillary Block With Mepivacaine.
|
Phase 3 | |
Recruiting |
NCT04820114 -
Proprioception and Multi Sensory Training After DRF
|
N/A |