Avenir Complete Post-Market Clinical Follow-Up Study

Sponsor

Zimmer Biomet (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04731077

Collaborator

(none)

300

Enrollment

Location

Arm

152.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Hip Avascular Necrosis of Hip Avascular Necrosis of the Femoral Head Post-traumatic; Arthrosis	Device: Avenir Complete Femoral Stem	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the Avenir Complete™ Femoral Stem (Implants and Instrumentation)

Actual Study Start Date :

Sep 27, 2021

Anticipated Primary Completion Date :

Jun 1, 2033

Anticipated Study Completion Date :

Jun 1, 2034

Arms and Interventions

Arm	Intervention/Treatment
Other: Avenir Complete Femoral Stem All enrolled subjects receive the study implant	Device: Avenir Complete Femoral Stem All enrolled subjects will receive the Avenir Complete Femoral Stem

Arm

Intervention/Treatment

Other: Avenir Complete Femoral Stem

All enrolled subjects receive the study implant

Device: Avenir Complete Femoral Stem

All enrolled subjects will receive the Avenir Complete Femoral Stem

Outcome Measures

Primary Outcome Measures

Survival of the study device; whether or not it is still implanted in the subject [10 years]
Survival is classified as removal of the study device for any reason

Secondary Outcome Measures

Incidence of treatment-emergent Adverse Events (safety) [10 years]
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 [3 years]
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 [10 years]
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 [10 years]
Postoperative radiographs will be analyzed by the Investigator
Oxford Hip Score [10 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mississippi Sports Medicine and Orthopaedic Center PLLC	Jackson	Mississippi	United States	39202

Sponsors and Collaborators

Zimmer Biomet

Investigators

Study Director: Ryan Boylan, Zimmer Biomet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zimmer Biomet

ClinicalTrials.gov Identifier:

NCT04731077

Other Study ID Numbers:

CMG2020-20H

First Posted:

Jan 29, 2021

Last Update Posted:

Mar 11, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022