Avenir® Cemented Hip Stem - PMCF

Femoral Neck Fractures Clinical Trial

Official title:

Prospective Post Market Clinical Follow-up Study of the Avenir® Cemented Hip Stem

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03396224
• Other study ID #: CME2013-03H
• Status: Active, not recruiting
• Start date: November 18, 2015
• Est. completion date: November 2030

Study information

• Verified date: July 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: November 2030
• Est. primary completion date: November 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Femoral Head Necrosis
• Femoral Neck Fractures
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteotomies
• Post-Traumatic Osteoarthritis of Hip
• Primary Osteoarthritis
• Sequelae From Previous Hip Surgery

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St-Luc UCL	Woluwe-Saint-Lambert	Brussels-Capital Region
France	Hôpital Gabriel Montpied - Service de chirurgie Orthopédique	Clermont Ferrand	Auvergne-Rhône-Alpes Region
France	Hopital Lapeyronie - Service Orthopédie	Montpellier	Occitanie Region

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method		10 years
Secondary	The results of the hip surgery will be 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).	10 years
Secondary	The patient's quality-of-life will be determined by the EQ-5D score	EQ-5D is a standardized instrument for measuring health status. It is made up for two components.; The description part: health status is measured in five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself. Usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have. In anxiety/depression dimension, it asks how anxious or depressed they are.; Visual analogue scale: The patient marks his health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. The bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".	10 years
Secondary	Abnormalities determined on X-rays in the bone region surrounding the implant will be reported		10 years
Secondary	Number of patient with adverse events related to the implant will be reported	Adverse events include: dislocations of the hip, revisions and removals of the implants	10 years