Continuum™ Metal 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
- Sponsor
- Zimmer Biomet
- Enrollment
- 83
- Locations
- 3
- Primary Endpoint
- Implant Survival at 10 Years
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and outcome data on the Continuum Metal Bearing System in primary total hip arthroplasty.
Detailed Description
The subject of this clinical investigation is the Continuum Metal Bearing THA System in primary total hip arthroplasty. This system consists of a cementless modular Trabecular Metal® (TM) Continuum Acetabular Shell, a modular Metasul Taper liner, and a modular Metasul 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. In total, 3 sites were involved. This number of clinical sites permitted assessment of the consistency among a multitude of investigators. A total number of 83 were included in the study.
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.
- •Patient is willing and able to cooperate in the required post-operative therapy.
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 neurologic condition in the ipsilateral 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.
- •The patient is unwilling or unable to give consent, or to comply with the follow-up program.
Outcomes
Primary Outcomes
Implant Survival at 10 Years
Time Frame: 1, 2, 3, 5, 7, and 10 years postop.
The primary endpoint for this study is implant survival at 10 years which was assessed by revision either of the Continuum Cup or the Metasul liner. A success rate for the experimental group was calculated using the Kaplan-Meier Survival Estimation.
Secondary Outcomes
- The Harris Hip Score (HHS)(Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op)
- The Subject Quality-of-Life (SF-12): Physical and Mental Socres(Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op)
- Radiographic Evaluations(Immediate-postop, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op.)
- Metal Ion Concentration in Blood(Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.)
- EQ5D(Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op)
- Creatine Concentration and BUN(Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.)
- Calculated GFR(Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.)