Continuum™ 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
- Osteoarthritis
- Sponsor
- Zimmer Biomet
- Enrollment
- 203
- Locations
- 6
- Primary Endpoint
- Safety will be evaluated by adverse events reporting.
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
The primary objective of this study is to obtain implant survivorship and clinical outcome data for the commercially available Zimmer® Continuum™ Ceramic-on-Ceramic Bearing System when used in primary 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 efficacy of the Continuum Ceramic-on-Ceramic Bearing System.
Detailed Description
The subject of this clinical investigation is the Continuum Ceramic Bearing THA System in primary total hip arthroplasty. This system consists of a cementless modular Trabecular Metal™ (TM) Continuum Acetabular Shell, a modular BIOLOX delta Taper liner, and a modular BIOLOX delta femoral head. The characteristics of this THA system may allow for reduction in wear and osteolysis as compared to other approved and marketed THA systems and thus increase the expected implant life. The study design will be a prospective, multicenter, non-comparative post-market study, involving orthopedic surgeons skilled in hip arthroplasty procedures. A total of 200 patients will be enrolled into the study distributed between 6 study centres. This number of clinical centers will permit assessment of consistency among a multitude of investigators. Follow-up visits will. be performed at 6 weeks, 6 months, 1,2, 3, 5; 7 and 10 years post-operatively. All potential study subjects will be required to participate in the Informed Consent Process. The safety and performance of the Implant System will be assessed as following: implant survivorship based on revision with removal of the study device; safety based on incidence and frequency of adverse events; and Performance will be determined by comparing the overall pain and functional performances, survivorship, subject quality-of-life and radiographic parameters of study subjects who received the Continuum Ceramic Bearing System.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is 21 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 chronic renal impairment or failure.
- •The patient has had previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the joint to be operated
- •The patient has a neurologic condition in the ipsolateral or contralateral limb which affects lower limb function.
Outcomes
Primary Outcomes
Safety will be evaluated by adverse events reporting.
Time Frame: 10 years
Safety 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)