MDR - Longevity IT Oblique and Offset Liners

Zimmer Biomet

Status: Terminated

Conditions: Protrusio Acetabuli; Osteoarthritis; Traumatic Arthritis; Diastrophic Variant; Fused Hip; Slipped Capital Femoral Epiphyses; Non-inflammatory Degenerative Joint Disease (NIDJD); Fracture of the Pelvis; Avascular Necrosis

Treatments: Device: Total Hip Arthroplasty with Longevity IT Oblique Liners; Device: Total Hip Arthroplasty with Longevity IT Offset Liners

Study type: Observational

Funder types: Industry

Identifiers

NCT05980234

MDRG2017-89MS-107H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

6 participants in 2 patient groups

Longevity IT Oblique Liners

Description:

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

Treatment:

Device: Total Hip Arthroplasty with Longevity IT Oblique Liners

Longevity IT Offset Liners

Description:

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

Treatment:

Device: Total Hip Arthroplasty with Longevity IT Offset Liners