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TerminatedNo phase

MDR - Longevity IT Oblique and Offset Liners

Key facts

Who runs it
Zimmer Biomet
Where
Philadelphia, United StatesSee the site
Trial code
Status
Terminated
People taking part
6 people enrolled
Started
30 Aug 2023
Ended
7 Nov 2024
Type of study
Observational, 2 groups
Treatments tested
  • Total Hip Arthroplasty with Longevity IT Oblique Liners
  • Total Hip Arthroplasty with Longevity IT Offset Liners
Record updated
27 December 2024
Why it stopped
Zimmer Biomet received the CE mark for the Continuum and Trilogy IT Acetabular System, which includes the Longevity IT Offset and Oblique Liners, in June 2024.

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patient is a known alcohol or drug abuser
  • 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 has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
  • Off-label use of study devices
  • Osteoradionecrosis
  • Patient is known to be pregnant or nursing
  • Patient is a prisoner

Where in United States

  • Rothman InstitutePhiladelphia, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Longevity IT Oblique Liners

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

    Treatment: Total Hip Arthroplasty with Longevity IT Oblique Liners

  • Longevity IT Offset Liners

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

    Treatment: Total Hip Arthroplasty with Longevity IT Offset Liners

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
PMCF Study to Provide Safety, Performance, and Clinical Benefits Data of the Longevity IT Oblique and Offset Liners in Primary and Revision Total Hip Arthroplasty - A Retrospective Enrollment/Prospective Follow-up Consecutive Series Study
Record updated
27 December 2024