- Confirming the survivorship under normal use of the Collared and Collarless versions of the Avenir Complete* stem (Standard, High Offset, Coxa Vara) and its instrumentation used in primary total, hemi, or revision hip arthroplasty by recording the…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is defined by the survival of the implant system at 10
years, which is based on the removal or intended removal of the *study device
and determined using Kaplan Meier method. The safety of the system will be
assessed by monitoring the frequency and incidence of adverse events. Relation
of the events to implant, instrumentation and/or procedure should be specified.
Secondary outcome
The secondary endpoints are the assessment of performance and clinical benefits
by recording patient-reported clinical outcomes measures (PROMs) as well as
radiographic outcomes (if available)
Background summary
The purpose of the Avenir Complete* stem is to enhance the existing Avenir
Müller cementless stem, which has more than 10 years of successful clinical
experience. Enhancements include a shortened distal geometry for a better fit,
extra sizes, a Coxa Vara offset, and a collared version to help the surgeon
reconstructing the patient*s anatomy.
This Post-Market Clinical Follow-up (PMCF) study is intended to fulfil post
market surveillance obligations according to Medical Device Directive, MEDDEV
2.12-2 and the Medical Devices Regulation (MDR 2017/745
Study objective
- Confirming the survivorship under normal use of the Collared and Collarless
versions of the Avenir Complete* stem (Standard, High Offset, Coxa Vara) and
its instrumentation used in primary total, hemi, or revision hip arthroplasty
by recording the incidence and frequency of revisions, complications, and
adverse events;
- verifying that, under normal use, the performance and clinical benefits of
this device and its instrumentation conform to those intended by the
manufacturer by recording patient-reported clinical outcomes measures (PROMs)
and radiographic outcomes (if available).
Study design
Global, Multicenter, Prospective, Non-controlled, Non-randomized, Consecutive
series of patients.
Intervention
NA
Study burden and risks
No additional risks compared to standard of care.
Toermalijnring 600
Dordrecht 3316LC
NL
Toermalijnring 600
Dordrecht 3316LC
NL
Listed location countries
Age
Inclusion criteria
- Patient is at least 20 years old or older and skeletally mature.
- Patient is capable of understanding the surgeon*s explanations and following
his instructions, able and willing to participate in the follow-up program and
who gave consent to take part in the study;
- Patient qualifies for total hip arthroplasty based on physical exam and
medical history including at least one of the following:
o Advanced wear of the joint due to degenerative, post-traumatic or rheumatic
diseases;
o Failed previous hip surgery including:
* joint reconstruction (osteotomy)
* Arthrodesis
* Hemi-arthroplasty or total hip replacement (THR);
o Acute traumatic fracture of the femoral head or neck;
o Avascular necrosis of the femoral head.
Exclusion criteria
- Acute, chronic, local, or systemic infections;
- Severe muscular, neural, or vascular diseases that endanger the limbs
involved;
- Lack of bony structures proximal or distal to the joint, so that good
anchorage of the implant is unlikely or impossible;
- Total or partial absence of the muscular or ligamentous apparatus;
- Any concomitant diseases that can jeopardize the functioning and the success
of the implant;
- Allergy to the implanted material, especially to metal (e.g. cobalt,
chromium, etc.);
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04731077 |
| CCMO | NL77682.100.21 |