Clinical trial NCT05980234: MDR - Longevity IT Oblique and Offset Liners
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: 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
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2023-08-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population should be a consecutive series of subjects implanted with the Longevity IT Oblique and/or Offset liners in either primary or revision THA. Up to 52 implanted hips with the Oblique liners and up to 52 implanted hips with the Offset liners will be included in the study.

The study population for primary statistical analysis will be comprised of males and females who satisfy the inclusion/exclusion criteria outlined in the protocol. To avoid potential selection bias, each Investigator will offer study participation to each consecutive eligible patient presenting as a potential candidate. Eligible candidates who express interest in study participation will be offered Informed Consent.

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

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 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.

Eligibility 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

Primary outcomes:
measure: Incidence of treatment-emergent Adverse Events (safety)
timeFrame: 10 years
Secondary outcomes:
measure: Pain and Functional Performance - Oxford Hip Score
timeFrame: 10 years
measure: Performance and Clinical Benefits - Harris Hip Score
timeFrame: 10 years
measure: Performance and Clinical Benefits - Activity Level
timeFrame: 10 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser
role: STUDY_DIRECTOR
References: