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MDR - Longevity IT Oblique and Offset Liners

NCT ID: NCT05980234

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-30

Study Completion Date

2024-11-07

Brief Summary

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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

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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

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Longevity IT Oblique Liners

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

Total Hip Arthroplasty with Longevity IT Oblique Liners

Intervention Type DEVICE

Primary or Revision Total Hip Arthroplasty using the Longevity IT Oblique liners according to the approved indications and compatible device.

Longevity IT Offset Liners

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

Total Hip Arthroplasty with Longevity IT Offset Liners

Intervention Type DEVICE

Primary or Revision Total Hip Arthroplasty using the Longevity IT Offset liners according to the approved indications and compatible device.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hillary Overholser

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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MDRG2017-89MS-107H

Identifier Type: -

Identifier Source: org_study_id