Avenir Complete Post-Market Clinical Follow-Up Study

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04731077
• Other study ID #: CMG2020-20H
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: June 1, 2036

Study information

• Verified date: March 2024
• Source: Zimmer Biomet
• Contact: Lisette Smid, PhD
• Phone: +31 62 395 6378
• Email: lisette.smid[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2036
• Est. primary completion date: June 1, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Avascular Necrosis of Hip
• Avascular Necrosis of the Femoral Head
• Necrosis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteonecrosis
• Post-traumatic; Arthrosis

Intervention

Device:
• Avenir Complete Femoral Stem
All enrolled subjects will receive the Avenir Complete Femoral Stem

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Hvidovre	Copenhagen
Japan	Okayama City Hospital	Okayama
Japan	Nissan Tamagawa Hospital	Setagaya-Ku	Tokyo
Netherlands	Ikazia Ziekenhuis	Rotterdam	Zuid-Holland
Norway	Sykehuset Innlandet HF	Tynset
Sweden	Sahlgrenska University Hospital - Molndal	Molndal
United States	Mississippi Sports Medicine and Orthopaedic Center PLLC	Jackson	Mississippi
United States	Orthopedic & Fracture Clinic, PC	Portland	Oregon
United States	Heartland Regional Medical Center d.b.a. Mosaic Life Care	Saint Joseph	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Denmark,  Japan,  Netherlands,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 years
Secondary	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.	10 years
Secondary	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).	3 years
Secondary	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/	10 years
Secondary	Radiographic analysis	Postoperative radiographs will be analyzed by the Investigator	10 years
Secondary	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.	10 years