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

NCT05199870 | Enrolling By Invitation FDA Device

• 1 other identifier: MDRG2017-89MS-43H
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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 and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Device Performance and Benefits evaluated through the Oxford Hip Score and Patient Assessment.

  Greater than or equal to 8 years.

Study Arms (2)

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

Endo II Femoral Heads

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

Device: Endo II Femoral Head

Interventions

RingLoc Bipolar Acetabular Cup DEVICE

Patients that have been implanted with a RingLoc Bipolar acetabular cup.

RingLoc Bipolar Acetabular Cup

Endo II Femoral Head DEVICE

Subjects that have been implanted with an Endo II Femoral Head

Endo II Femoral Heads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Hip Fractures; Hip Injuries

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Lynsey Boyle

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 20, 2022
• Study Start: March 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)