Clinical trial NCT04731077: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Hip
Avascular Necrosis of Hip
Avascular Necrosis of the Femoral Head
Post-traumatic; Arthrosis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2021-01-29
Enrollment: 275
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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;

Primary outcomes:
measure: Survival of the study device; whether or not it is still implanted in the subject
timeFrame: 10 years
Secondary outcomes:
measure: Incidence of treatment-emergent Adverse Events (safety)
timeFrame: 10 years
measure: Harris Hip Score
timeFrame: 3 years
measure: Patient Quality of Life
timeFrame: 10 years
measure: Radiographic analysis
timeFrame: 10 years
measure: Oxford Hip Score
timeFrame: 10 years
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Mississippi Sports Medicine and Orthopaedic Center PLLC
state: Mississippi
city: Saint Joseph
country: United States
facility: Heartland Regional Medical Center d.b.a. Mosaic Life Care
state: Missouri
city: Portland
country: United States
facility: Orthopedic & Fracture Clinic, PC
state: Oregon
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Hvidovre
city: Setagaya-Ku
country: Japan
facility: Nissan Tamagawa Hospital
state: Tokyo
city: Okayama
country: Japan
facility: Okayama City Hospital
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
state: Zuid-Holland
city: Tynset
country: Norway
facility: Sykehuset Innlandet HF
city: Molndal
country: Sweden
facility: Sahlgrenska University Hospital - Molndal
Study officials:
References: