Prospective Post Market Clinical Follow-up Study of the Avenir® Cemented Hip Stem
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Primary Osteoarthritis
- Sponsor
- Zimmer Biomet
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
- Status
- Active, Not Recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
Time Frame: 10 years
Secondary Outcomes
- Number of patient with adverse events related to the implant will be reported(10 years)
- The patient's quality-of-life will be determined by the EQ-5D score(10 years)
- Abnormalities determined on X-rays in the bone region surrounding the implant will be reported(10 years)
- The results of the hip surgery will be determined by the Harris Hip Score(10 years)