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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05199870
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Lynsey Boyle
Principal Investigator Affiliation Zimmer Biomet
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries, Hip Pain Chronic
Additional Details

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).

Arms & Interventions

Arms

: RingLoc Bipolar Acetabular Cup

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

: Endo II Femoral Heads

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

Interventions

Device: - RingLoc Bipolar Acetabular Cup

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

Device: - Endo II Femoral Head

Subjects that have been implanted with an Endo II Femoral Head

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Inova Fairfax Hospital, Falls Church, Virginia

Status

Address

Inova Fairfax Hospital

Falls Church, Virginia, 22042

Site Contact

Grag Gaski, MD

[email protected]

980-259-2813

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