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