MDR - PMCF Study for RingLoc Bipolar Acetabular Cup

Suspended

• Conditions: Hip Fractures; Hip Pain Chronic; Hip Arthritis; Hip Disease; Hip Injuries
• Interventions: Device: Echo FX Stem with RingLoc Bipolar Acetabular Cup and Femoral Head

• Registration Number: NCT05199870
• Lead Sponsor: Zimmer Biomet

Brief Summary

The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup when used for hip hemiarthroplasty (implants and instrumentation).

Detailed Description

The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup when used for hip hemiarthroplasty (implants and instrumentation).

The primary objective of this study is the assessment of safety by analyzing implant survivorship at the longest follow-up timepoint available, greater than or equal to eight years post-implantation. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to implant, instrumentation and/or procedure should be specified.

The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs).

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Study Start: 2025-04
• Primary Completion: 2030-09-03
• Study Completion: 2030-09-03

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Echo FX Stem with RingLoc Bipolar Acetabular Cup and Femoral Head	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 to repair hip malfunction/disease/injury.

Primary Outcome Measures

Name	Time	Method
Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events.	Greater than or equal to 8 years.	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.

Secondary Outcome Measures

Name	Time	Method
Device Performance and Benefits evaluated through the Oxford Hip Score and Patient Assessment.	Greater than or equal to 8 years.	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. The Patient Assessment is patient completed and a 4-question evaluation.

Trial Locations

Locations (1)

Vicksburg Clinic, LLC; 🇺🇸 Vicksburg, Mississippi, United States