NCT05980234

MDR - Longevity IT Oblique and Offset Liners

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-30
• Primary completion: 2024-11-02
• Completion: 2024-11-07
• First posted: 2023-08-07
• Last updated: 2024-12-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study