Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty: A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Avascular Necrosis of Hip
- Sponsor
- Zimmer Biomet
- Enrollment
- 185
- Locations
- 4
- Primary Endpoint
- Survivorship
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a multi-center, prospective, non-controlled post market surveillance study. The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.
Detailed Description
The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and performance of the Allofit IT Ceramic Bearing System. A total of 200 patients are planned to be enrolled in this study which will last 12 years (2 year enrollment plus 10 years follow-up) with the follow-up visits at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is 18 to 75 years of age, inclusive.
- •Patient is skeletally mature.
- •Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:
- •Avascular necrosis (AVN)
- •Osteoarthritis (OA)
- •Inflammatory arthritis (i.e. Rheumatoid arthritis)
- •Post-traumatic arthritis
- •Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s).
- •Patient has a Harris Hip Score \<70 in the affected hip
- •Patient is willing and able to provide written informed consent.
Exclusion Criteria
- •The patient is:
- •A prisoner
- •Mentally incompetent or unable to understand what participation in the study entails
- •A known alcohol or drug abuser
- •Anticipated to be non-compliant.
- •The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- •The patient has a vascular (large and small vessel disease) insufficiency.
- •The patient has a neurologic condition in the ipsalateral or contralateral limb which affects lower limb function.
- •The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.
- •The patient is known to be pregnant.
Outcomes
Primary Outcomes
Survivorship
Time Frame: 10 years post-surgery
The objective of this study is implant survival at 10 years which is assessed by revision of the the study device calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component.
Safety of the Implant
Time Frame: Up to 10 years postoperative
Will be evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) b) Efficacy:
Secondary Outcomes
- Harris Hip Score(pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year)
- EQ-5D(pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year)
- SF-12 Physical and Mental Functional Scores(pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year)
- UCLA Activity Score(pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year)
- Radiographic Evaluations(10 Years post-surgery)