Avenir Complete Post-Market Clinical Follow-Up Study
Primary Purpose
Osteoarthritis, Hip, Avascular Necrosis of Hip, Avascular Necrosis of the Femoral Head
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avenir Complete Femoral Stem
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip
Eligibility Criteria
Inclusion Criteria:
- Patient is at least 20 years old or older and skeletally mature.
- Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
Failed previous hip surgery including
- Joint reconstruction (osteotomy)
- Arthrodesis
- Hemi-arthroplasty or total hip replacement (THR)
- Acute traumatic fracture of the femoral head or neck;
- Avascular necrosis of the femoral head.
- Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study;
Exclusion Criteria:
- Acute, chronic, local, or systemic infections;
- Severe muscular, neural, or vascular diseases that endanger the limbs involved;
- Lack of bony structures proximal or distal to the joint, so that good Inclusion criteria
- Patient is at least 20 years old or older and skeletally mature.
- Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
Failed previous hip surgery including
- Joint reconstruction (osteotomy)
- Arthrodesis
- Hemi-arthroplasty or total hip replacement (THR)
- Acute traumatic fracture of the femoral head or neck;
- Avascular necrosis of the femoral head.
- Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study;
Exclusion criteria
- Acute, chronic, local, or systemic infections;
- Severe muscular, neural, or vascular diseases that endanger the limbs involved;
- Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible;
- Total or partial absence of the muscular or ligamentous apparatus;
- Any concomitant diseases that can jeopardize the functioning and the success of the implant;
- Allergy to the implanted material, especially to metal (e.g. cobalt, chromium, nickel, etc.);
- Local bone tumors and/or cysts;
- Pregnancy;
- Skeletal immaturity.
- Patients unwilling or unable to give consent, or to comply with the follow-up program;
- Patients who have any condition that would - in the judgement of the Investigator - place him/her at undue risk or
- interfere with the study;
Any vulnerable subject:
- a prisoner
- mentally incompetent or unable to understand what participation in the study entails
- a known alcohol or drug abuser
- anticipated to be non-compliant
- Patients with plans to relocate during the study follow-up period;
- Individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate;
Sites / Locations
- Mississippi Sports Medicine and Orthopaedic Center PLLCRecruiting
- Heartland Regional Medical Center d.b.a. Mosaic Life CareRecruiting
- Orthopedic & Fracture Clinic, PCRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Avenir Complete Femoral Stem
Arm Description
All enrolled subjects receive the study implant
Outcomes
Primary Outcome Measures
Survival of the study device; whether or not it is still implanted in the subject
Survival is classified as removal of the study device for any reason
Secondary Outcome Measures
Incidence of treatment-emergent Adverse Events (safety)
Safety is assessed by monitoring the frequency and incidence of all adverse events, with particular focus on those that may be related to the study device.
Harris Hip Score
Functional outcomes are measured with the Harris Hip Score, including range of motion, pain level, activity levels and patient satisfaction. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Patient Quality of Life
This is another self-assessment by means of the EQ-5D-5L (EuroQol) score, which measures the patient's perceived quality of life.
EQ VAS: Score between 0 and 100 recorded by an individual, 100 being the highest.
EQ 5D Value: "The value attached to an EQ-5D profile according to a set of weights that reflect, on average, people's preferences about how good or bad the state is. Values are anchored at 1 (full health) and 0 (a state as bad as being dead)" https://euroqol.org/support/terminology/
Radiographic analysis
Postoperative radiographs will be analyzed by the Investigator
Oxford Hip Score
The Oxford Hip Score (OHS) is a joint-specific, patient-reported outcome measure tool designed to assess disability in patients undergoing total hip replacement.
The score is measured on a scale of 0 to 48 with 48 being the best outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04731077
Brief Title
Avenir Complete Post-Market Clinical Follow-Up Study
Official Title
Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the Avenir Complete™ Femoral Stem (Implants and Instrumentation)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
June 1, 2033 (Anticipated)
Study Completion Date
June 1, 2034 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.
Detailed Description
The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete™ femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty:
The primary endpoint is defined by the survival of the implant system at 10 years, which is based on the removal or intended removal of the "study device and determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Avascular Necrosis of Hip, Avascular Necrosis of the Femoral Head, Post-traumatic; Arthrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Avenir Complete Femoral Stem
Arm Type
Other
Arm Description
All enrolled subjects receive the study implant
Intervention Type
Device
Intervention Name(s)
Avenir Complete Femoral Stem
Intervention Description
All enrolled subjects will receive the Avenir Complete Femoral Stem
Primary Outcome Measure Information:
Title
Survival of the study device; whether or not it is still implanted in the subject
Description
Survival is classified as removal of the study device for any reason
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent Adverse Events (safety)
Description
Safety is assessed by monitoring the frequency and incidence of all adverse events, with particular focus on those that may be related to the study device.
Time Frame
10 years
Title
Harris Hip Score
Description
Functional outcomes are measured with the Harris Hip Score, including range of motion, pain level, activity levels and patient satisfaction. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Time Frame
3 years
Title
Patient Quality of Life
Description
This is another self-assessment by means of the EQ-5D-5L (EuroQol) score, which measures the patient's perceived quality of life.
EQ VAS: Score between 0 and 100 recorded by an individual, 100 being the highest.
EQ 5D Value: "The value attached to an EQ-5D profile according to a set of weights that reflect, on average, people's preferences about how good or bad the state is. Values are anchored at 1 (full health) and 0 (a state as bad as being dead)" https://euroqol.org/support/terminology/
Time Frame
10 years
Title
Radiographic analysis
Description
Postoperative radiographs will be analyzed by the Investigator
Time Frame
10 years
Title
Oxford Hip Score
Description
The Oxford Hip Score (OHS) is a joint-specific, patient-reported outcome measure tool designed to assess disability in patients undergoing total hip replacement.
The score is measured on a scale of 0 to 48 with 48 being the best outcome.
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is at least 20 years old or older and skeletally mature.
Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
Failed previous hip surgery including
Joint reconstruction (osteotomy)
Arthrodesis
Hemi-arthroplasty or total hip replacement (THR)
Acute traumatic fracture of the femoral head or neck;
Avascular necrosis of the femoral head.
Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study;
Exclusion Criteria:
Acute, chronic, local, or systemic infections;
Severe muscular, neural, or vascular diseases that endanger the limbs involved;
Lack of bony structures proximal or distal to the joint, so that good Inclusion criteria
Patient is at least 20 years old or older and skeletally mature.
Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
Failed previous hip surgery including
Joint reconstruction (osteotomy)
Arthrodesis
Hemi-arthroplasty or total hip replacement (THR)
Acute traumatic fracture of the femoral head or neck;
Avascular necrosis of the femoral head.
Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study;
Exclusion criteria
Acute, chronic, local, or systemic infections;
Severe muscular, neural, or vascular diseases that endanger the limbs involved;
Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible;
Total or partial absence of the muscular or ligamentous apparatus;
Any concomitant diseases that can jeopardize the functioning and the success of the implant;
Allergy to the implanted material, especially to metal (e.g. cobalt, chromium, nickel, etc.);
Local bone tumors and/or cysts;
Pregnancy;
Skeletal immaturity.
Patients unwilling or unable to give consent, or to comply with the follow-up program;
Patients who have any condition that would - in the judgement of the Investigator - place him/her at undue risk or
interfere with the study;
Any vulnerable subject:
a prisoner
mentally incompetent or unable to understand what participation in the study entails
a known alcohol or drug abuser
anticipated to be non-compliant
Patients with plans to relocate during the study follow-up period;
Individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darin A Fawley, MA
Phone
5743067230
Email
darin.fawley@zimmerbiomet.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Boylan, MBA
Phone
574-371-9784
Email
ryan.boylan@zimmerbiomet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Boylan
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Mississippi Sports Medicine and Orthopaedic Center PLLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doug Parsell
Facility Name
Heartland Regional Medical Center d.b.a. Mosaic Life Care
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pat Schildknecht, RN
Phone
816-271-7237
Email
patricia.schildknecht@mymlc.com
First Name & Middle Initial & Last Name & Degree
Trisha D England
Phone
816-271-7937
Email
Trisha.England2@mymlc.com
First Name & Middle Initial & Last Name & Degree
Blake Peterson, MD
Facility Name
Orthopedic & Fracture Clinic, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqui Shelton
Phone
503-214-5209
Email
jacquline.shelton@OandFS.com
First Name & Middle Initial & Last Name & Degree
Sam Kirby
Phone
503) 214-5200
Email
sam.kirby@oandfs.com
First Name & Middle Initial & Last Name & Degree
Alex DeHaan, MD
First Name & Middle Initial & Last Name & Degree
Paul Duwelius, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Avenir Complete Post-Market Clinical Follow-Up Study
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