MDR - PMCF Study for Echo FX Stem With RingLoc Bipolar Acetabular Cup &

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

The objective of this retrospective enrollment and prospective follow-up study is to confirm safety, performance, and clinical benefits of the Echo FX Stem with the RingLoc Bipolar Acetabular Cup and Femoral Head in hip hemiarthroplasty (implants and instrumentation) at a minimum of 10 years follow-up. All available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point. The primary objective is to confirm the safety of the implants. This will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events. Relationship of the events to either implant or instrumentation will be specified. The secondary objective is the assessment of performance and clinical benefits by analyzing recorded Patient Reported Outcomes Measures (PROMs). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05199870
Study type	Observational
Source	Zimmer Biomet
Contact	Richard Marek
Phone	574-453-7567
Email	richard.marek@zimmerbiomet.com
Status	Recruiting
Phase
Start date	December 17, 2021
Completion date	September 3, 2030

View Details

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

MDR - PMCF Study for Echo FX Stem With RingLoc Bipolar Acetabular Cup and Femoral Head

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms