Avenir Complete Post-Market Clinical Follow-Up Study

Not Applicable

Recruiting

• Conditions: Avascular Necrosis of Hip; Avascular Necrosis of the Femoral Head; Osteoarthritis, Hip; Post-traumatic; Arthrosis
• Interventions: Device: Avenir Complete Femoral Stem

• Registration Number: NCT04731077
• Lead Sponsor: Zimmer Biomet

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).

Study Timeline

• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-01-29
• Study Start: 2021-09-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2035-06-01
• Study Completion: 2036-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avenir Complete Femoral Stem	Avenir Complete Femoral Stem	All enrolled subjects receive the study implant

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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/
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).

Trial Locations

Locations (9)

Okayama City Hospital; 🇯🇵 Okayama, Japan

Sykehuset Innlandet HF; 🇳🇴 Tynset, Norway

Orthopedic & Fracture Clinic, PC; 🇺🇸 Portland, Oregon, United States

Mississippi Sports Medicine and Orthopaedic Center PLLC; 🇺🇸 Jackson, Mississippi, United States

Heartland Regional Medical Center d.b.a. Mosaic Life Care; 🇺🇸 Saint Joseph, Missouri, United States

Sahlgrenska University Hospital - Molndal; 🇸🇪 Molndal, Sweden

Nissan Tamagawa Hospital; 🇯🇵 Setagaya-Ku, Tokyo, Japan

Ikazia Ziekenhuis; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Copenhagen University Hospital, Hvidovre; 🇩🇰 Copenhagen, Denmark