MDR - PMCF Study for RingLoc Bipolar Acetabular Cup

Zimmer Biomet

Status: Suspended

Conditions: Hip Injuries; Hip Fractures; Hip Disease; Hip Arthritis; Hip Pain Chronic

Treatments: Device: Echo FX Stem with RingLoc Bipolar Acetabular Cup and Femoral Head

Study type: Observational

Funder types: Industry

Identifiers

NCT05199870

MDRG2017-89MS-43H

Details and patient eligibility

About

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).

Full 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).

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

58 participants in 1 patient group

Echo FX Stem with RingLoc Bipolar Acetabular Cup and Femoral Head

Description:

Patients that have been implanted with a Echo FX stem with RingLoc Bipolar acetabular cup and femoral head to repair hip malfunction/disease/injury.

Treatment:

Device: Echo FX Stem with RingLoc Bipolar Acetabular Cup and Femoral Head