Status:
TERMINATED
MDR - Longevity IT Oblique and Offset Liners
Lead Sponsor:
Zimmer Biomet
Conditions:
Non-inflammatory Degenerative Joint Disease (NIDJD)
Avascular Necrosis
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed 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 Longevity IT Oblique ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 7 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05980234
Start Date
August 30 2023
End Date
November 7 2024
Last Update
December 27 2024
Active Locations (1)
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1
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107