MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners

Hip Fractures Clinical Trial

Official title:

Post-market Clinical Follow-up Study of the G7 Freedom Constrained Neutral Liner and G7 Neutral +5mm Liner in Primary and Revision Total Hip Arthroplasty (Implants and Instrumentation)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04093739
• Other study ID #: MDRG2017-89MS-53H
• Status: Withdrawn
• Start date: April 2022
• Est. completion date: December 31, 2029

Study information

• Verified date: December 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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. 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. The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hip Disease
• Hip Fractures
• Hip Injuries
• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Device Performance and Benefits evaluated through the Oxford Hip Score	The OHS is a patient completed 12 question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms.	Out to five years