Clinical Trials Logo

Clinical Trial Summary

This is an observational, prospective and multicenter clinical investigation that is part of the active materiovigilance plan that Orthofix Srl, in agreement with its Notified Body. The sponsor has planned to actively collect clinical data relating to the use of Chimaera Intramedullary Nail in a representative number of users and elderly patients with fractures of the proximal femur. The data obtained from this clinical investigation will be used to complete the pre-market clinical evaluation carried out on the Chimaera with post-market clinical data from the use of the device in normal clinical practice.


Clinical Trial Description

Orthofix Srl has developed and placed on the European market the Chimaera Intramedullary Nail after having evaluated the clinical performance and safety of the medical device based on biomechanical tests and clinical data obtained from scientific publications on equivalent products. The outcome of this pre-market assessment established that Chimaera possesses the requirements for CE marking, in particular, it possesses an acceptable risk/benefit ratio if used according to the manufacturer's directions for use. The enrolled patients, as would happen even if they did not decide to participate in this study, will proceed by undergoing the surgery necessary for the application of the medical device under observation (Chimaera), which coincides with the start of the treatment period. After the surgery and the hospital discharge, the patient will undergo subsequent follow-up visits. The follow-up visits carried out respectively at 1 month and 3 months after the date of surgery, conclude the treatment period which, barring complications, is expected within 8 - 12 weeks from the date of surgery with the consolidation of the fracture of the proximal femur treated. Healing will be verified by the Investigator based on an X-ray check through which he/she will make a qualitative assessment of the bone density at the fracture site and the positioning of the bone stumps. Starting from the 3-month visit and up to 1-year visit, the Investigator will compile the Bowers & Parker functional score (a measure of effectiveness) for the evaluation of the patient's functional recovery. The score obtained at the follow-up visits will be compared to the score compiled during the discharge visit representative of the pre-fracture patient's status. For patients that undergo this treatment, the removal of the device is not planned except for serious adverse events that require a second surgery to complete the treatment of the fracture (safety measure). Once the treatment period has ended, the control period begins during which 2 visits will be made, respectively 6 months and 1 year after the date of the surgery. During these visits, clinical data will be collected to follow the evolution of the fracture consolidation and the functional recovery of the patient and the occurrence of any adverse events in the medium term. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05197335
Study type Observational
Source Orthofix s.r.l.
Contact
Status Active, not recruiting
Phase
Start date July 9, 2020
Completion date July 31, 2022

See also
  Status Clinical Trial Phase
Completed NCT02507609 - Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium N/A
Completed NCT03906864 - Care Pathway for Sub-acute Hip Rehabilitation N/A
Recruiting NCT04063891 - Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients N/A
Completed NCT05039879 - Life Improving Factors After a Hip Fracture
Not yet recruiting NCT03887494 - Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY) N/A
Terminated NCT03065101 - Trigen InterTAN vs Sliding Hip Screw RCT N/A
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Completed NCT03545347 - Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture. Phase 2
Recruiting NCT05971173 - Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery Early Phase 1
Active, not recruiting NCT04957251 - Anterior vs Posterior Approach for Hip Hemiarthroplasty N/A
Terminated NCT04372966 - Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures N/A
Withdrawn NCT05030688 - Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty N/A
Completed NCT04424186 - 'Rehabilitation for Life' N/A
Not yet recruiting NCT04183075 - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture N/A
Withdrawn NCT05518279 - Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures Phase 3
Not yet recruiting NCT02892968 - ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients N/A
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Active, not recruiting NCT02247791 - Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty N/A
Completed NCT00746876 - Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. N/A
Completed NCT00058864 - The HIP Impact Protection Program (HIP PRO) N/A