Trial Outcomes & Findings for Avenir Müller Hip Stem Post Market Surveillance Study (NCT NCT04079127)

Last Updated: 2021-05-14

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

150 participants

Primary outcome timeframe

10 years

Results posted on

2021-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Suffering From Severe Hip Pain and Disability Patients in need of a total hip arthroplasty. 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.
Overall Study STARTED	150
Overall Study COMPLETED	89
Overall Study NOT COMPLETED	61

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Suffering From Severe Hip Pain and Disability n=150 Participants Patients in need of a total hip arthroplasty. Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem and who met the study inclusion/exclusion criteria .
Age, Continuous	60.5 years STANDARD_DEVIATION 10.4 • n=150 Participants
Sex: Female, Male Female	76 Participants n=150 Participants
Sex: Female, Male Male	74 Participants n=150 Participants
Body Mass Index (BMI) kg/m2	27.3 kg/m^2 STANDARD_DEVIATION 4.0 • n=150 Participants
Height (cm)	168.6 cm STANDARD_DEVIATION 8.8 • n=150 Participants
Weight (kg)	78.1 kg STANDARD_DEVIATION 14.2 • n=150 Participants

PRIMARY outcome

Timeframe: 10 years

Population: The HHS values are within the interval 0-100 points and the higher the score is, the better the outcome is for the individuals. The results are interpreted with the following ratings: \<70 points = poor result; 70-79 points = fair, 80-89 points = good, and 90-100 points = excellent. Number Of Unilateral Patients: 68; Number Of Bilateral Patients:7. Here, the data at 10 year post surgery of 75 patients (82 hips) were available for analysis.

Outcome measures

Outcome measures
Measure	Patients Suffering From Severe Hip Pain and Disability n=82 Implants Patients in need of a total hip arthroplasty. 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.
Evaluation of Pain and Functional Performance Determined by the Harris Hip Score	90.9 score on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: up to 10 years

Population: Revisions due to any component (Avenir Muller Hip Stem, Acetabular Insert , Acetabular Cup...) complication.

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.

Outcome measures

Outcome measures
Measure	Patients Suffering From Severe Hip Pain and Disability n=150 Implants Patients in need of a total hip arthroplasty. 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.
Confirmation of Safety Based on Complications	10 Patients

SECONDARY outcome

Timeframe: 10 years

Population: Kaplan-Meier survival rate at 10 years post-surgery,with Avenir Muller Hip Stem revision for any reason as endpoint. Number of Unilateral Patients: 88; Number of Bilateral Patients: 4. Data of 88 patients,96 hips were received up to 10 years post surgery for the survival. Indeed, if a patient did not come back for a visit, the information if the implant was still in place was provided (gives higher numbers than for the clinical evaluation).

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).

Outcome measures

Outcome measures
Measure	Patients Suffering From Severe Hip Pain and Disability n=96 Implants Patients in need of a total hip arthroplasty. 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.
Survivorship of the Implant	98.54 percentage implant survival

Adverse Events

Patients Suffering From Severe Hip Pain and Disability

Serious events: 17 serious events

Other events: 14 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Patients Suffering From Severe Hip Pain and Disability n=141 participants at risk Patients in need of a total hip arthroplasty. 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.
Surgical and medical procedures Fracture of Femoral Shaft	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Surgical and medical procedures Bascule Implant cotyl	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Social circumstances Post traumatic Pain on acetabular	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Social circumstances Cup pain after Trauma	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Infections and infestations Deep Infection (>6 Weeks	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Cardiac disorders Cardiac Arrhythmia	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Renal and urinary disorders Urinary Retention	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Surgical and medical procedures Bascule Insert acetabular	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Vascular disorders Pulmonary Embolism	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Blood and lymphatic system disorders Myelofibrosis	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Immune system disorders Reaction Due To Metal Bearing	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Product Issues Metallosis	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Surgical and medical procedures Calcar crack	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Infections and infestations Deep Infection (>6 Weeks)	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Blood and lymphatic system disorders Scar Inflammation	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
General disorders Death	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Blood and lymphatic system disorders Stroke	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.

Other adverse events

Other adverse events
Measure	Patients Suffering From Severe Hip Pain and Disability n=141 participants at risk Patients in need of a total hip arthroplasty. 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.
Congenital, familial and genetic disorders Polymyalgia rheumatica	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Renal and urinary disorders Kidney stone	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Blood and lymphatic system disorders Anaemia	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Blood and lymphatic system disorders Stroke	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Cardiac disorders Cardiac Arrhythmia	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Infections and infestations Urinary Tract Infection	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Infections and infestations Respiratory Infection	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Vascular disorders Pulmonary Embolism	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Surgical and medical procedures Dislocation	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Blood and lymphatic system disorders Hodgkin's disease	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Renal and urinary disorders Nephrectomy L and Partiel R	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
General disorders Instability	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Surgical and medical procedures Subluxation	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.
Musculoskeletal and connective tissue disorders Ankylosing Spondylartis	0.71% 1/141 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative). All the 141 patients were considered in the Adverse Events report section as any hip could have an Adverse Event at any time of the study.

Additional Information

Emilie Rohmer, Clinical Operations Manager

Zimmer Biomet

Phone: +41 58 85 48210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place