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.
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.
Study Type
OBSERVATIONAL
Enrollment
83
\<Metal-on-Metal Articulation\>: Metasul® Taper Liner and Metasul Femoral Head, \<Acetabular Component\>:Continuum Acetabular Shell, \<Femoral Component\>: Zimmer® M/L Taper Hip Stem
Saint Davids Medical Center
Austin, Texas, United States
Jokilaakson terveys oy
Jämsä, Finland
Hospital District of Southwest Finland
Turku, Finland
Implant Survival at 10 Years
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.
Time frame: 1, 2, 3, 5, 7, and 10 years postop.
The Harris Hip Score (HHS)
The Harris hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care Professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). The total score can vary from a range of 0 - 100. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70.
Time frame: 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
SF12: The SF-12 is a multipurpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time frame: Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op
Radiographic Evaluations
Radiographic evaluation was performed in order to identify potential adverse events. Investigators at each site were responsible for reviewing the radiological images for any abnormal or significant findings and reporting adverse events if applicable. In addition, an independent radiographic reviewer performed assessments of radiographic films in terms of evidence of radiolucencies, osteolysis, subsidence, acetabular cup migration, and change in acetabular cup angle at 6 months, 1 year and 2 year post-operation. Outcomes included numbers of reported findings per anatomical position and time point.
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Time frame: Immediate-postop, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op.
Metal Ion Concentration in Blood
Metal ion levels (cobalt, chromium and titanium) were analyzed by an approved Central Laboratory at the time points listed below for all study subjects enrolled in this study. In addition, prior to a revision surgery, a blood draw for metal ion data collection was performed.
Time frame: Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.
EQ5D
EQ5D: The EQ-5D is a standardized Instrument widely used to measure health status. It is a self reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self care, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573; negative numbers correspond to a self-assessed health state worse than being dead. The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The warst health you can imagine') where the patient reports his/her self-rated health.
Time frame: Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op
Creatine Concentration and BUN
Renal function (BUN and Creatinine) were analyzed by an approved Central Laboratory at the time points listed below for all study subjects enrolled in this study. In addition, prior to a revision surgery, a blood draw for metal ion data collection was performed.
Time frame: Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.
Calculated GFR
Renal function (BUN, Creatinine and GFR) were analyzed by an approved Central Laboratory at the time points listed below for all study subjects enrolled in this study. In addition, prior to a revision surgery, a blood draw for metal ion data collection was performed.
Time frame: Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.