Avascular Necrosis, Inflammatory Arthritis, Osteoarthritis, Post-traumatic; Arthrosis, Total Hip Arthroplasty
Conditions
Keywords
Total hip arthroplasty, Medical Device, Post Market Surveillance Study, Performance, Safety
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.
Interventions
DEVICEMetal-on-Metal Articulation
\<Metal-on-Metal Articulation\>: Metasul® Taper Liner and Metasul Femoral Head, \<Acetabular Component\>:Continuum Acetabular Shell, \<Femoral Component\>: Zimmer® M/L Taper Hip Stem
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. * Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. * Patient has participated in the Informed Consent process and has signed the Ethics Committee approved 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 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. * The patient has received an investigational drug or device within the previous 6 months. * The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously. The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock. * The patient has known local bone tumors and/or cysts in the operative hip. * The patient has a known allergic reaction to one or more of the implanted material. * The patient is Grade III obese with a Body Mass Index (BMI) ≥ 40. * The patient has osteoradionecrosis in the affected hip joint * Kidney insufficiency (Kidney insufficiency will be determined based on eGFR value. See Blood Analysis Report CRF for details)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival at 10 Years | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Radiographic Evaluations | Immediate-postop, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op. | 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. |
| Metal Ion Concentration in Blood | Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op. | 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. |
| The Harris Hip Score (HHS) | Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op | 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. |
| Creatine Concentration and BUN | Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op. | 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. |
| Calculated GFR | Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op. | 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. |
| EQ5D | Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op | 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. |
Countries
Finland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Who Received the Continuum Metal on Metal System Patients required total hip arthroplasty, who met the inclusion/exclusion criteria and received the Continuum Metal on Metal System | 83 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Other reasons | 21 |
| Overall Study | Patient withdrew | 3 |
| Overall Study | Revision | 5 |
Baseline characteristics
| Characteristic | Patients Who Received the Continuum Metal on Metal System | — |
|---|---|---|
| Age, Continuous | 57.7 years | — |
| BMI | 28.6 kg/m² | — |
| Diagnosis Avascular Necrosis | 7 participants | — |
| Diagnosis Osteoarthritis | 74 participants | — |
| Diagnosis Rheumatoid Arthritis | 2 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Finland | 57 participants | — |
| Region of Enrollment United States | 26 participants | — |
| Sex: Female, Male Female | 44 Participants | — |
| Sex: Female, Male Male | 39 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 83 |
| other Total, other adverse events | 62 / 83 |
| serious Total, serious adverse events | 25 / 83 |
Outcome results
Primary
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.
Population: All study patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Who Received the Continuum Metal on Metal System | Implant Survival at 10 Years | 1-year Kaplan Meier Survival Estimate | 98.8 percentage of participants |
| Patients Who Received the Continuum Metal on Metal System | Implant Survival at 10 Years | 2-year Kaplan Meier Survival Estimate | 97.5 percentage of participants |
| Patients Who Received the Continuum Metal on Metal System | Implant Survival at 10 Years | 3-year Kaplan Meier Survival Estimate | 96.16 percentage of participants |
| Patients Who Received the Continuum Metal on Metal System | Implant Survival at 10 Years | 5-year Kaplan Meier Survival Estimate | 96.16 percentage of participants |
| Patients Who Received the Continuum Metal on Metal System | Implant Survival at 10 Years | 7-year Kaplan Meier Survival Estimate | 92.87 percentage of participants |
| Patients Who Received the Continuum Metal on Metal System | Implant Survival at 10 Years | 10-year Kaplan Meier Survival Estimate | 91.01 percentage of participants |
Secondary
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.
Population: The numbers of participants listed for renal function demonstrated the number of participants tested.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Who Received the Continuum Metal on Metal System | Calculated GFR | Preop (GRF) | 99.3 mL/min/1.73 m² | Standard Deviation 34.5 |
| Patients Who Received the Continuum Metal on Metal System | Calculated GFR | 6-month (GRF) | 101.8 mL/min/1.73 m² | Standard Deviation 26.4 |
| Patients Who Received the Continuum Metal on Metal System | Calculated GFR | 1-year (GRF) | 98 mL/min/1.73 m² | Standard Deviation 23.8 |
| Patients Who Received the Continuum Metal on Metal System | Calculated GFR | 2-year (GRF) | 92.1 mL/min/1.73 m² | Standard Deviation 24 |
| Patients Who Received the Continuum Metal on Metal System | Calculated GFR | 5-year (GRF) | 83.4 mL/min/1.73 m² | Standard Deviation 16 |
Secondary
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.
Population: The numbers of participants listed for renal function demonstrated the number of participants tested.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Who Received the Continuum Metal on Metal System | Creatine Concentration and BUN | 6-month (BUN) | 14.3 mg/dl | Standard Deviation 5.1 |
| Patients Who Received the Continuum Metal on Metal System | Creatine Concentration and BUN | 1-year (BUN) | 14.1 mg/dl | Standard Deviation 5 |
| Patients Who Received the Continuum Metal on Metal System | Creatine Concentration and BUN | 2-year (BUN) | 14.2 mg/dl | Standard Deviation 5.9 |
| Patients Who Received the Continuum Metal on Metal System | Creatine Concentration and BUN | Preop (Creatine) | 0.8 mg/dl | Standard Deviation 0.2 |
| Patients Who Received the Continuum Metal on Metal System | Creatine Concentration and BUN | 6-month (Creatine) | 0.8 mg/dl | Standard Deviation 0.2 |
| Patients Who Received the Continuum Metal on Metal System | Creatine Concentration and BUN | 1-year (Creatine) | 0.9 mg/dl | Standard Deviation 0.2 |
| Patients Who Received the Continuum Metal on Metal System | Creatine Concentration and BUN | 2-year (Creatine) | 0.9 mg/dl | Standard Deviation 0.2 |
| Patients Who Received the Continuum Metal on Metal System | Creatine Concentration and BUN | 5-year (Creatine) | 0.9 mg/dl | Standard Deviation 0.2 |
| Patients Who Received the Continuum Metal on Metal System | Creatine Concentration and BUN | Preop (BUN) | 14.9 mg/dl | Standard Deviation 4.9 |
| Patients Who Received the Continuum Metal on Metal System | Creatine Concentration and BUN | 5-year (BUN) | 15.2 mg/dl | Standard Deviation 4.5 |
Secondary
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
Population: All study patients. At preoperative, EQ-5D scores of only 57 patients (not collected at the US site) were available for this report.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Who Received the Continuum Metal on Metal System | EQ5D | Preop EQ-5D-5L | 0.6 units on a scale | Standard Deviation 0.2 |
| Patients Who Received the Continuum Metal on Metal System | EQ5D | 6-week EQ-5D-5L | 0.8 units on a scale | Standard Deviation 0.1 |
| Patients Who Received the Continuum Metal on Metal System | EQ5D | 6-month EQ-5D-5L | 0.9 units on a scale | Standard Deviation 0.1 |
| Patients Who Received the Continuum Metal on Metal System | EQ5D | 1-year EQ-5D-5L | 0.9 units on a scale | Standard Deviation 0.1 |
| Patients Who Received the Continuum Metal on Metal System | EQ5D | 2-year EQ-5D-5L | 1.0 units on a scale | Standard Deviation 0.1 |
| Patients Who Received the Continuum Metal on Metal System | EQ5D | 3-year EQ-5D-5L | 1.0 units on a scale | Standard Deviation 0.1 |
| Patients Who Received the Continuum Metal on Metal System | EQ5D | 5-year EQ-5D-5L | 0.9 units on a scale | Standard Deviation 0.2 |
| Patients Who Received the Continuum Metal on Metal System | EQ5D | 7-year EQ-5D-5L | 0.9 units on a scale | Standard Deviation 0.1 |
| Patients Who Received the Continuum Metal on Metal System | EQ5D | 10-year EQ-5D-5L | 0.9 units on a scale | Standard Deviation 0.2 |
Secondary
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.
Population: The numbers of participants listed for metal ion concentrations indicate the number of participants who showed metal ion levels above the detectable limit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | Preop (Chromium) | 1.1 ng/ml | Standard Deviation 0.6 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | 6-month (Chromium) | 1.8 ng/ml | Standard Deviation 1 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | 1-year (Chromium) | 2.3 ng/ml | Standard Deviation 2 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | 2-year (Chromium) | 2.4 ng/ml | Standard Deviation 1.6 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | 5-year (Chromium) | 2.2 ng/ml | Standard Deviation 1.3 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | Preop (Cobalt) | 1.2 ng/ml | Standard Deviation 1.1 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | 6-Month (Cobalt) | 2.2 ng/ml | Standard Deviation 1.4 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | 1-year (Cobalt) | 2.9 ng/ml | Standard Deviation 3.6 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | 2-year (Cobalt) | 2.2 ng/ml | Standard Deviation 1.1 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | 5-year (Cobalt) | 2.3 ng/ml | Standard Deviation 1.9 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | Preop (Titanium) | 4.9 ng/ml | Standard Deviation 1.2 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | 6-month (Titanium) | 5.4 ng/ml | Standard Deviation 1.9 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | 1-year (Titanium) | 6.1 ng/ml | Standard Deviation 0.7 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | 2-year (Titanium) | 4.6 ng/ml | Standard Deviation 2.3 |
| Patients Who Received the Continuum Metal on Metal System | Metal Ion Concentration in Blood | 5-year (Titanium) | NA ng/ml | Standard Deviation 0 |
Secondary
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.
Time frame: Immediate-postop, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op.
Population: All study patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Who Received the Continuum Metal on Metal System | Radiographic Evaluations | Total significant findings | 34 number of findings |
| Patients Who Received the Continuum Metal on Metal System | Radiographic Evaluations | Acetabular side | 6 number of findings |
| Patients Who Received the Continuum Metal on Metal System | Radiographic Evaluations | Femoral side | 26 number of findings |
| Patients Who Received the Continuum Metal on Metal System | Radiographic Evaluations | Other | 2 number of findings |
| Patients Who Received the Continuum Metal on Metal System | Radiographic Evaluations | Immed-postop | 1 number of findings |
| Patients Who Received the Continuum Metal on Metal System | Radiographic Evaluations | 6-week | 5 number of findings |
| Patients Who Received the Continuum Metal on Metal System | Radiographic Evaluations | 6-month | 2 number of findings |
| Patients Who Received the Continuum Metal on Metal System | Radiographic Evaluations | 1-year | 5 number of findings |
| Patients Who Received the Continuum Metal on Metal System | Radiographic Evaluations | 2-year | 6 number of findings |
| Patients Who Received the Continuum Metal on Metal System | Radiographic Evaluations | 3-year | 4 number of findings |
| Patients Who Received the Continuum Metal on Metal System | Radiographic Evaluations | 5-year | 3 number of findings |
| Patients Who Received the Continuum Metal on Metal System | Radiographic Evaluations | 7-year | 6 number of findings |
| Patients Who Received the Continuum Metal on Metal System | Radiographic Evaluations | 10-year | 2 number of findings |
Secondary
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
Population: All study patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Who Received the Continuum Metal on Metal System | The Harris Hip Score (HHS) | Preop | 45.1 score on a scale | Standard Deviation 12.3 |
| Patients Who Received the Continuum Metal on Metal System | The Harris Hip Score (HHS) | 6-week | 85.1 score on a scale | Standard Deviation 14.5 |
| Patients Who Received the Continuum Metal on Metal System | The Harris Hip Score (HHS) | 6-month | 93.2 score on a scale | Standard Deviation 11.3 |
| Patients Who Received the Continuum Metal on Metal System | The Harris Hip Score (HHS) | 1-year | 92.2 score on a scale | Standard Deviation 12.7 |
| Patients Who Received the Continuum Metal on Metal System | The Harris Hip Score (HHS) | 2-year | 93.8 score on a scale | Standard Deviation 10.1 |
| Patients Who Received the Continuum Metal on Metal System | The Harris Hip Score (HHS) | 3-year | 93.6 score on a scale | Standard Deviation 12.9 |
| Patients Who Received the Continuum Metal on Metal System | The Harris Hip Score (HHS) | 5-year | 95 score on a scale | Standard Deviation 9 |
| Patients Who Received the Continuum Metal on Metal System | The Harris Hip Score (HHS) | 7-year | 93.5 score on a scale | Standard Deviation 11.6 |
| Patients Who Received the Continuum Metal on Metal System | The Harris Hip Score (HHS) | 10-year | 91.0 score on a scale | Standard Deviation 14 |
Secondary
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
Population: All study patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | Preop SF-12 (Physical) | 29.8 score on a scale | Standard Deviation 7.4 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 6-week SF-12 (Physical) | 41.8 score on a scale | Standard Deviation 8.5 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 6-month SF-12 (Physical) | 48.4 score on a scale | Standard Deviation 9.2 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 1-year SF-12 (Physical) | 49.5 score on a scale | Standard Deviation 9.2 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 2-year SF-12 (Physical) | 50.0 score on a scale | Standard Deviation 8.1 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 3-year SF-12 (Physical) | 50.7 score on a scale | Standard Deviation 8.7 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 5-year SF-12 (Physical) | 49.5 score on a scale | Standard Deviation 9.8 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 7-year SF-12 (Physical) | 48.8 score on a scale | Standard Deviation 10.5 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 10-year SF-12 (Physical) | 47.9 score on a scale | Standard Deviation 9.6 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | Preop SF-12 (Mental) | 52.4 score on a scale | Standard Deviation 10.7 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 6-week SF-12 (Mental) | 56.3 score on a scale | Standard Deviation 8.4 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 6-month SF-12 (Mental) | 56.6 score on a scale | Standard Deviation 7.2 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 1-year SF-12 (Mental) | 56.3 score on a scale | Standard Deviation 7.3 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 2-year SF-12 (Mental) | 57.6 score on a scale | Standard Deviation 7.2 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 3-year SF-12 (Mental) | 57.9 score on a scale | Standard Deviation 6 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 5-year SF-12 (Mental) | 57.4 score on a scale | Standard Deviation 6.3 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 7-year SF-12 (Mental) | 55.6 score on a scale | Standard Deviation 8.3 |
| Patients Who Received the Continuum Metal on Metal System | The Subject Quality-of-Life (SF-12): Physical and Mental Socres | 10-year SF-12 (Mental) | 57.3 score on a scale | Standard Deviation 6.5 |