Avenir Müller Hip Stem Post Market Surveillance Study
CompletedResults postedLast updated 14 May 2021
What this trial tests
trial testing Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem. in Osteoarthritis, Hip in 150 participants. Completed in 31 August 2019.
18 and older, any sex, with Osteoarthritis, Hip or Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Evaluation of Pain and Functional Performance Determined by the Harris Hip ScorePrimary· 10 years
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 measu
Group
Value
95% CI
Patients Suffering From Severe Hip Pain and Disability
90.9
± 11.7
Confirmation of Safety Based on ComplicationsSecondary· up to 10 years
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.
Group
Value
95% CI
Patients Suffering From Severe Hip Pain and Disability
10
Survivorship of the ImplantSecondary· 10 years
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).
Group
Value
95% CI
Patients Suffering From Severe Hip Pain and Disability
98.54
Adverse events — posted to ClinicalTrials.gov
Time frame: The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Patients Suffering From Severe Hip Pain and Disability
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zimmer Biomet
Last refreshed: 14 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04079127.