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

Post-Market Clinical Follow-Up Study to Provide Safety, Performance and Clinical Benefits Data of the RingLoc Bipolar Acetabular Cup or Endo II Heads (Implants and Instrumentation) in Hip Hemiarthroplasty - A Retrospective Enrollment/Prospective Follow-Up Consecutive Series Study

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Hip Pain Chronic; Hip Fractures; Hip Injuries; Hip Disease; Hip Arthritis
• Intervention / Treatment: Device: RingLoc Bipolar Acetabular Cup; Device: Endo II Femoral Head

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 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).

• Study Type: Observational
• Enrollment (Estimated): 116

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A consecutive series of patients implanted with the RingLoc Bipolar acetabular cup or the Endo II Femoral Head.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RingLoc Bipolar Acetabular Cup; Patients that have been implanted with the RingLoc Bipolar acetabular cup to repair hip malfunction/disease/injury.	Device: RingLoc Bipolar Acetabular Cup; Patients that have been implanted with a RingLoc Bipolar acetabular cup.
Endo II Femoral Heads; Subjects who were implanted with the Endo II Femoral head during hemiarthroplasty	Device: Endo II Femoral Head; Subjects that have been implanted with an Endo II Femoral Head

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Greater than or equal to 8 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Performance and Benefits evaluated through the Oxford Hip Score and Patient Assessment.	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.	Greater than or equal to 8 years.

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Lynsey Boyle, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Fractures; Hip Injuries
• Other Study ID Numbers: MDRG2017-89MS-43H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes