Dislocated Hip, Fracture of Hip, Osteoarthritis, Hip, Osteonecrosis, Post-traumatic; Arthrosis, Rheumatoid Arthritis, Subluxation Hip
Conditions
Brief 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.
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.
Interventions
DEVICEPatients 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.
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Pain and Functional Performance Determined by the Harris Hip Score | 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 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confirmation of Safety Based on Complications | 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. |
| Survivorship of the Implant | 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Suffering From Severe Hip Pain and Disability 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 . | 150 |
| Total | 150 |
Baseline characteristics
| Characteristic | Patients Suffering From Severe Hip Pain and Disability | — |
|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 10.4 | — |
| Body Mass Index (BMI) kg/m2 | 27.3 kg/m^2 STANDARD_DEVIATION 4 | — |
| Height (cm) | 168.6 cm STANDARD_DEVIATION 8.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 76 Participants | — |
| Sex: Female, Male Male | 74 Participants | — |
| Weight (kg) | 78.1 kg STANDARD_DEVIATION 14.2 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 141 |
| other Total, other adverse events | 14 / 141 |
| serious Total, serious adverse events | 17 / 141 |
Outcome results
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Suffering From Severe Hip Pain and Disability | Evaluation of Pain and Functional Performance Determined by the Harris Hip Score | 90.9 score on a scale | Standard Deviation 11.7 |
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.
Time frame: up to 10 years
Population: Revisions due to any component (Avenir Muller Hip Stem, Acetabular Insert , Acetabular Cup...) complication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Suffering From Severe Hip Pain and Disability | Confirmation of Safety Based on Complications | 10 Patients |
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).
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Suffering From Severe Hip Pain and Disability | Survivorship of the Implant | 98.54 percentage implant survival |