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MDR-G7 Freedom Constrained Liners

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04093739
Recruitment Status : Not yet recruiting
First Posted : September 18, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment
Hip Osteoarthritis Hip Disease Hip Fractures Hip Injuries Device: G7 Freedom Constrained Liners

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).

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Study Type : Observational
Estimated Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the G7 Freedom Constrained Liners in Primary and Revision Total Hip Arthroplasty
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Device Safety assessed through the frequency and incidence of revisions, complications and adverse events [ Time Frame: Out to five years ]
    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.


Secondary Outcome Measures :
  1. Device Performance and Benefits evaluated through the Oxford Hip Score [ Time Frame: Out to five years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093739


Contacts
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Contact: Madison K Oakes 5743733951 madison.oakes@zimmerbiomet.com
Contact: Paula Phillips 7204926961 paula.phillips@zimmerbiomet.com

Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kacy Arnold Zimmer Biomet

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT04093739    
Other Study ID Numbers: MDRG2017-89MS-53H
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Hip Fractures
Hip Injuries
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries