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

Hip Fractures Clinical Trial

Official title:

Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Echo FX Stem With the RingLoc Bipolar Acetabular Cup and Femoral Head (Implants and Instrumentation) in Hip Hemiarthroplasty - A Retrospective Enrollment/Prospective Follow-up Consecutive Series Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199870
• Other study ID #: MDRG2017-89MS-43H
• Status: Recruiting
• Start date: December 17, 2021
• Est. completion date: September 3, 2030

Study information

• Verified date: September 2023
• Source: Zimmer Biomet
• Contact: Richard Marek
• Phone: 574-453-7567
• Email: richard.marek[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: September 3, 2030
• Est. primary completion date: September 3, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient must be 18 years of age or older and skeletally mature
• Patient must be willing and able to sign IRB approved informed consent
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
• Revision procedures where other treatment or devices have failed

Exclusion Criteria:

• Off-label use
• Uncooperative patient or patient with neurological disorders who are incapable of following directions
• Osteoporosis
• Metabolic disorders which may impair bone formation
• Osteomalacia
• Distant foci of infections which may spread to the implant site
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• Vascular insufficiency, muscular atrophy, or neuromuscular disease
• Infection
• Sepsis
• Osteomyelitis
• Patient is known to be pregnant or nursing
• Patient is a prisoner
• Patient is a known alcohol or drug abuser
• Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
• Patient is unwilling to sign an informed consent

Related Conditions & MeSH terms

• Hip Arthritis
• Hip Disease
• Hip Fractures
• Hip Injuries
• Hip Pain Chronic

Intervention

Device:
• Echo FX Stem with RingLoc Bipolar Acetabular Cup and Femoral Head
Patients that have been implanted with a Echo FX stem with RingLoc Bipolar acetabular cup and femoral head.

Locations

Country	Name	City	State
United States	Vicksburg Clinic, LLC	Vicksburg	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events.	The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and Adverse Events. Relation of the events to either implant or instrumentation will be specified.	Out to 10 years.
Secondary	Device Performance and Benefits evaluated through the Oxford Hip Score.	The OHS is a patient-completed, 12-question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms.	Out to 10 years.