Clinical trial NCT04093739: MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners
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)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hip Osteoarthritis
Hip Disease
Hip Fractures
Hip Injuries
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Device Safety assessed through the frequency and incidence of revisions, complications and adverse events
timeFrame: Out to five years
Secondary outcomes:
measure: Device Performance and Benefits evaluated through the Oxford Hip Score
timeFrame: Out to five years
Other outcomes:
Locations:
Study officials:
affiliation: Zimmer Biomet
name: Erin Osborn
role: STUDY_DIRECTOR
References: