Avenir Müller Hip Stem Post Market Surveillance Study

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04079127
• Other study ID #: 09H08
• Status: Completed
• Start date: January 9, 2010
• Est. completion date: August 31, 2019

Study information

• Verified date: April 2021
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 31, 2019
• Est. primary completion date: June 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dislocated Hip
• Fracture of Hip
• Hip Fractures
• Joint Diseases
• Osteoarthritis, Hip
• Osteonecrosis
• Post-traumatic; Arthrosis
• Rheumatoid Arthritis
• Subluxation Hip

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Hip International