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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

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT04731077

First Posted

January 28, 2021

Last Updated

May 9, 2023

Sponsor

Zimmer Biomet

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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

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

Time Frame

3 years

Title

Patient Quality of Life

Description

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

Time Frame

10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

darin.fawley@zimmerbiomet.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ryan Boylan, MBA

Phone

574-371-9784

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

patricia.schildknecht@mymlc.com

First Name & Middle Initial & Last Name & Degree

Trisha D England

Phone

816-271-7937

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

jacquline.shelton@OandFS.com

First Name & Middle Initial & Last Name & Degree

Sam Kirby

Phone

503) 214-5200

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

Learn more about this trial

Avenir Complete Post-Market Clinical Follow-Up Study

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