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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04731077
Other study ID # CMG2020-20H
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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