Clinical Trial Finder

MDR - Longevity IT Oblique and Offset Liners

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 Longevity IT Oblique and Offset liners when used for primary or revision total hip arthroplasty (implants and instrumentation) at a minimum of 10-year follow-up.

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:

  • - Study devices must have been implanted following the appropriate surgical technique and IFU.
  • - Patient must be 18 years of age or older.
  • - Patient must be willing and able to sign or verbally consent using the IRB approved informed consent.
  • - Patient must have undergone primary or revision hip arthroplasty with the Longevity IT Oblique and/or Offset liners according to a cleared indication, which includes the following: - Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital, epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
  • - Revision where other devices or treatments have failed.
  • - Patient must have reached full skeletal maturity.

Exclusion Criteria:

  • - Off-label use of study devices.
  • - Osteoradionecrosis.
  • - Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation.
  • - Systemic or local infection.
  • - Uncooperative patient or patient with neurologic disorders who is incapable of following directions.
  • - Patient is known to be pregnant or nursing.
  • - Patient is a prisoner.
  • - Patient is a known alcohol or drug abuser.
- Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent

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.

 NCT05980234
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.

 Hillary Overholser
Principal Investigator Affiliation Zimmer Biomet
Agency Class

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

 Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

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

 Non-inflammatory Degenerative Joint Disease (NIDJD), Avascular Necrosis, Protrusio Acetabuli, Traumatic Arthritis, Slipped Capital Femoral Epiphyses, Fracture of the Pelvis, Diastrophic Variant, Osteoarthritis, Fused Hip
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 Longevity IT Oblique and Offset liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 1, 3, 5, 7, and 10 years*. The subject devices have been on the market since 2010 but have insufficient data to support 10 years of clinical history. A prospective aspect to the study will be utilized to collect long-term data.

Arms & Interventions

Arms

: Longevity IT Oblique Liners

The Longevity IT Oblique liner was designed to provide variable joint anteversion and abduction.

: Longevity IT Offset Liners

The Longevity IT Offset liner was designed to lateralize the center of rotation of the cup.

Interventions

Device: - Total Hip Arthroplasty with Longevity IT Oblique Liners

Primary or Revision Total Hip Arthroplasty using the Longevity IT Oblique liners according to the approved indications and compatible device.

Device: - Total Hip Arthroplasty with Longevity IT Offset Liners

Primary or Revision Total Hip Arthroplasty using the Longevity IT Offset liners according to the approved indications and compatible device.

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.

Rothman Institute, Philadelphia, Pennsylvania

Status

Address

Rothman Institute

Philadelphia, Pennsylvania, 19107

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