MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners

NCT04093739 | Withdrawn FDA Device

• 1 other identifier: MDRG2017-89MS-53H
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.

Conditions

Hip Osteoarthritis; Hip Disease; Hip Fractures; Hip Injuries

Outcome Measures

Primary Outcomes (1)

• Device Safety assessed through the frequency and incidence of revisions, complications and adverse events

  The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.

  Out to five years

Secondary Outcomes (1)

• Device Performance and Benefits evaluated through the Oxford Hip Score

  Out to five years

Study Arms (1)

G7 Freedom Constrained Liners

Patients that have been implanted with a G7 Freedom Constrained liner to repair hip malfunction or disease.

Device: G7 Freedom Constrained Liners

Interventions

G7 Freedom Constrained Liners DEVICE

Patients that have been implanted with the G7 Freedom Constrained Liners to repair hip malfunction and/or disease.

G7 Freedom Constrained Liners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This will include a consecutive series of subjects implanted with the G7 Freedom Constrained Liners in primary and revision total hip arthroplasty according to the approved

You may qualify if:

• Patient must be 18 years of age or older and skeletally mature
• Patient must be willing and able to sign Institution Review Board (IRB) approved informed consent
• Noninflammatory degenerative joint disease including:
• Osteoarthritis
• Avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other -techniques
• High risk of dislocation due to:
• History of prior dislocation
• Bone loss
• Joint or soft tissue laxity
• Neuromuscular disease
• Intraoperative instability
• Revision procedures where other treatment or devices have failed

You may not qualify if:

• Off-label use
• Infection and/or distant foci of infections which may spread to the implant site
• Sepsis
• Osteomyelitis
• Uncooperative patient or patient with neurologic disorders who are incapable of following directions
• Osteoporosis
• Metabolic disorders which may impair bone formation
• Osteomalacia
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• Vascular insufficiency, muscular atrophy or neuromuscular disease
• 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
• Patient is unwilling to sign an informed consent

Sponsors & Collaborators

• Zimmer Biomet: lead

MeSH Terms

Conditions

Osteoarthritis, Hip; Hip Fractures; Hip Injuries

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Erin Osborn

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: September 18, 2019
• Study Start: April 1, 2022
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share