Clinical trial NCT03396224: Avenir® Cemented Hip Stem - PMCF
Official title: Prospective Post Market Clinical Follow-up Study of the Avenir® Cemented Hip Stem
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Osteoarthritis
Post-Traumatic Osteoarthritis of Hip
Femoral Neck Fractures
Femoral Head Necrosis
Sequelae From Previous Hip Surgery
Osteotomies
Congenital Hip Dysplasia
Keywords: Total hip arthroplasty
Hip implant
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who:

* are in need of a primary total hip arthroplasty
* receive the Avenir® Cemented Hip Stem and compatible femoral head and acetabular cup
* meet all the inclusion criteria and none of the exclusion criteria

Brief summary: The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.

Detailed description: This is a multicenter, prospective, non-controlled post-market clinical follow-up study to fulfill the post market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2.

The objectives of this study are to confirm the safety and performance of the Avenir Cemented Hip Stem when used in primary total hip arthroplasty at 6 weeks to 6 months, 1, 2, 3, 5, 7 and 10 years post-operatively.

The Avenir Cemented Hip Stem is a straight double-tapered stem offering 9 standard and 9 lateralized versions, the same as the uncemented version, the Avenir-Mueller Stem.

Safety will be evaluated by monitoring the frequency and incidence of adverse events and through radiographic review.

Performance will be based on the implant survival, overall pain and functional performances, subject quality-of-life and radiographic parameters of study subjects who received the Avenir® Cemented Hip stem.

Implant survival will be based on removal or intended removal of the device.

A total of 130 patients will be enrolled into the study at up to 4 sites.

Eligibility criteria: Inclusion Criteria:

* Patient is 18 years of age minimum.
* Patient is suffering from severe hip pain and disability requiring primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history.
* Patient is willing and able to cooperate in the required post-operative therapy.
* Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.

Exclusion Criteria:

* Patient is unwilling or unable to give consent, or to comply with the follow-up program.
* 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., stainless steel).
* Local bone tumors and/or cysts.
* Pregnancy
* Skeletal immaturity
* Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, a known drug abuser or alcoholic or anyone who cannot understand what is required of them.
* Patients with plans to relocate during the study follow-up period.
* For patients biologically younger than 60 years with joint disease, a different reconstruction operation (e.g., osteotomy) or arthrodesis may be indicated.

Primary outcomes:
measure: Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
timeFrame: 10 years
Secondary outcomes:
measure: The results of the hip surgery will be determined by the Harris Hip Score
timeFrame: 10 years
measure: The patient's quality-of-life will be determined by the EQ-5D score
timeFrame: 10 years
measure: Abnormalities determined on X-rays in the bone region surrounding the implant will be reported
timeFrame: 10 years
measure: Number of patient with adverse events related to the implant will be reported
timeFrame: 10 years
Other outcomes:
Locations:
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires St-Luc UCL
state: Brussels-Capital Region
city: Clermont Ferrand
country: France
facility: Hôpital Gabriel Montpied - Service de chirurgie Orthopédique
state: Auvergne-Rhône-Alpes Region
city: Montpellier
country: France
facility: Hopital Lapeyronie - Service Orthopédie
state: Occitanie Region
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: