Avenir Müller Hip Stem Post Market Surveillance Study

A Multi-centre, Non-comparative, Retrospective Post-market Surveillance Study to Obtain Clinical Outcomes Data on the Zimmer Avenir Müller Hip Stem

This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Avenir Müller Hip Stem.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Osteonecrosis; Osteoarthritis, Hip; Post-traumatic; Arthrosis; Fracture of Hip; Dislocated Hip; Subluxation Hip
• Intervention / Treatment: Device: Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.

Detailed Description

The objective of this post market surveillance study is to obtain outcome data on the Avenir Müller Hip Stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to assess the long-term performance and safety of this implant.

This is a multi-centre, retrospective post-market surveillance study involving orthopaedic surgeons skilled in hip surgery. Each case enrolled has received the Avenir Müller Hip Stem for a primary hip arthroplasty. The Avenir Müller Hip Stem is CE marked (European Conformity) and commercially available.

• Study Type: Observational
• Enrollment (Actual): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients suffering from severe hip pain and disability requiring a total hip arthroplasty.

Description

Inclusion Criteria:

• Patients able to participate in a follow-up program based upon physical examination and medical history.
• Patients or patient's legal representatives who have given written consent to take part in the study by signing the 'Patient Consent Form'.
• 18 years minimum.
• Male and female.
• Baseline data exist (pre-, peri- and immediate postoperative)

Exclusion Criteria:

• Patients who are unwilling or unable to comply with the follow-up program.
• Known pregnancy.
• Patients who are skeletally immature.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients suffering from severe hip pain and disability; Patients in need of a total hip arthroplasty.	Device: Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.; Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Pain and Functional Performance Determined by the Harris Hip Score	The Harris Hip Score is a questionnaire filled by the surgeon with the patient who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. 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).	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmation of Safety Based on Complications	Number of patients with adverse events related to the implant will be reported. Adverse events include: dislocations of the hip, revisions and removals of the implant components. Here, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the complications occured from the early stages of the study, and up to 10 year post surgery, and could occur to any patients.	up to 10 years
Survivorship of the Implant	Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method. Here, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the revisions could happen from the early stages of the study, and up to 10 year post surgery, and could occur to any patients. Even if a patient did not come back for a visit, the information if the implant was still in place was provided and taken into account for the survival analysis (gives higher numbers than for the clinical evaluation).	10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Publications and helpful links

General Publications

• Erivan R, Villatte G, Brientini JM, Kreider D, Descamps S, Boisgard S. 7-year results of primary total hip arthroplasty with the uncemented Avenir stem. Hip Int. 2019 Jul;29(4):418-423. doi: 10.1177/1120700018810211. Epub 2018 Nov 11.

Helpful Links

• Hip International

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2010
• Primary Completion (Actual): June 29, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: September 2, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Bone Diseases; Femoral Fractures; Hip Injuries; Osteoarthritis; Hip Fractures; Osteoarthritis, Hip; Osteonecrosis
• Other Study ID Numbers: 09H08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No