MDR - Longevity IT Oblique and Offset Liners

NCT05980234 | Terminated FDA Device

• 1 other identifier: MDRG2017-89MS-107H
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent Adverse Events (safety)

  This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events with particular focus on those that may be related to the study device.

  10 years

Secondary Outcomes (3)

• Pain and Functional Performance - Oxford Hip Score

  10 years

• Performance and Clinical Benefits - Harris Hip Score

  10 years

• Performance and Clinical Benefits - Activity Level

  10 years

Study Arms (2)

Longevity IT Oblique Liners

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

Device: Total Hip Arthroplasty with Longevity IT Oblique Liners

Longevity IT Offset Liners

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

Device: Total Hip Arthroplasty with Longevity IT Offset Liners

Interventions

Total Hip Arthroplasty with Longevity IT Oblique Liners DEVICE

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

Longevity IT Oblique Liners

Total Hip Arthroplasty with Longevity IT Offset Liners DEVICE

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

Longevity IT Offset Liners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Osteonecrosis; Slipped Capital Femoral Epiphyses; Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Osteochondrodysplasias; Bone Diseases, Developmental; Epiphyses, Slipped; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 7, 2023
• Study Start: August 30, 2023
• Primary Completion: November 2, 2024
• Study Completion: November 7, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)