MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads

Zimmer Biomet

Status: Not yet enrolling

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

Treatments: Device: RingLoc Bipolar Acetabular Cup; Device: Endo II 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 and the Endo II Femoral Head 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 and the Endo II Femoral Head 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: 116 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 have undergone hip hemiarthroplasty surgery with the RingLoc Bipolar Acetabular Cup or Endo II Femoral Head for a cleared indication, greater than or equal to eight years previous to the date of study consent. Cleared indications for the RingLoc Bipolar and Endo II Heads include the following:

  • Noninflammatory 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 using other techniques.

Exclusion criteria

• Any medical diagnosis present at the time of surgery that, at the Investigator's discretion, could compromise the implant's survivability
• Off-label use or not according to the approved instructions for use (IFU) of study devices
• Revision procedures where other treatment or devices have failed
• Uncooperative patient or patient with neurologic disorders who is incapable of following directions
• Patient has a psychiatric illness or

Trial design

116 participants in 2 patient groups

RingLoc Bipolar Acetabular Cup

Description:

Patients that have been implanted with the RingLoc Bipolar acetabular cup to repair hip malfunction/disease/injury.

Treatment:

Device: RingLoc Bipolar Acetabular Cup

Endo II Femoral Heads

Description:

Subjects who were implanted with the Endo II Femoral head during hemiarthroplasty

Treatment:

Device: Endo II Femoral Head