NOT_YET_RECRUITING

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

Conditions

Hip Arthritis Hip Disease Hip Fractures Hip Injuries Hip Pain Chronic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-08

Study Completion:2030-09-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:NOT_YET_RECRUITING

Study ID

NCT05199870

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Taylor Rowe

CONTACT

980-259-2813

taylor.rowe@zimmerbiomet.com

Principal Investigator

Lynsey Boyle

STUDY_DIRECTOR

Zimmer Biomet

Study Locations (Sites)

Inova Fairfax Hospital

Falls Church, Virginia, 22042

United States

Collaborators and Investigators

Sponsor: Zimmer Biomet

Lynsey Boyle, STUDY_DIRECTOR, Zimmer Biomet

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2030-09-03

Study Record Updates

Study Start Date2025-08

Study Completion Date2030-09-03

Terms related to this study

Additional Relevant MeSH Terms

Hip Arthritis
Hip Disease
Hip Fractures
Hip Injuries
Hip Pain Chronic