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

NCT ID: NCT05199870

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-30

Study Completion Date

2030-09-03

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Hip Arthritis Hip Disease Hip Fractures Hip Injuries Hip Pain Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RingLoc Bipolar Acetabular Cup

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

RingLoc Bipolar Acetabular Cup

Intervention Type DEVICE

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

Endo II Femoral Head

Intervention Type DEVICE

Subjects that have been implanted with an Endo II Femoral Head

Interventions

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RingLoc Bipolar Acetabular Cup

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

Intervention Type DEVICE

Endo II Femoral Head

Subjects that have been implanted with an Endo II Femoral Head

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lynsey Boyle

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status

Countries

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United States

Central Contacts

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Taylor Rowe

Role: CONTACT

Phone: 980-259-2813

Email: [email protected]

Facility Contacts

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Grag Gaski, MD

Role: primary

Other Identifiers

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MDRG2017-89MS-43H

Identifier Type: -

Identifier Source: org_study_id