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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received the Continuum Metal on Metal System | Patients requiring total hip arthroplasty, who meet the inclusion/exclusion criteria and received the Continuum Metal on Metal System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metal-on-Metal Articulation | Device | <Metal-on-Metal Articulation>: Metasul® Taper Liner and Metasul Femoral Head, <Acetabular Component>:Continuum Acetabular Shell, <Femoral Component>: Zimmer® M/L Taper Hip Stem |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1, 2, 3, 5, 7, and 10 years postop. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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:
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)
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The study population will be comprised of max. 100 males and females who require primary total hip arthroplasty. Subjects will be enrolled at 3 investigative centers. Subjects must be geographically accessible throughout the study and be willing and able to attend required follow-up appointments. Candidates who express interest in study participation will be offered informed consent, and eligibility will be determined based upon the inclusion/exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Achakri | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Davids Medical Center | Austin | Texas | 78705 | United States | ||
| Jokilaakson terveys oy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Who Received the Continuum Metal on Metal System | Patients requiring total hip arthroplasty, who met the inclusion/exclusion criteria and received the Continuum Metal on Metal System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All study patients | Posted | Number | 95% Confidence Interval | percentage of participants | 1, 2, 3, 5, 7, and 10 years postop. |
|
|
Safety was 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) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Who Received the Continuum Metal on Metal System | Patients requiring total hip arthroplasty, who meet the inclusion/exclusion criteria and received the Continuum Metal on Metal System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other General Complication | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal (non-hip) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
The US site was terminated after the 7-year follow up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Esther Foo | Zimmer Biomet | +41787183202 | esther.foo@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2012 | Dec 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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| 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. | 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. | 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. | 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. | 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. | 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. | Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op. |
| Jämsä |
| Finland |
| Hospital District of Southwest Finland | Turku | FI-00029 HUS | Finland |
| Patient withdrew |
|
| Other reasons |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Full Range | kg/m² |
|
| Diagnosis | Number | participants |
|
| Participants |
|
|
| 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. | All study patients | Posted | Mean | Standard Deviation | score on a scale | Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op |
|
|
|
| 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. | All study patients | Posted | Mean | Standard Deviation | score on a scale | Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op |
|
|
|
| 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. | All study patients | Posted | Number | number of findings | Immediate-postop, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op. |
|
|
|
| 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. | The numbers of participants listed for metal ion concentrations indicate the number of participants who showed metal ion levels above the detectable limit. | Posted | Mean | Standard Deviation | ng/ml | Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op. |
|
|
|
| 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. | All study patients. At preoperative, EQ-5D scores of only 57 patients (not collected at the US site) were available for this report. | Posted | Mean | Standard Deviation | units on a scale | Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op |
|
|
|
| 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. | The numbers of participants listed for renal function demonstrated the number of participants tested. | Posted | Mean | Standard Deviation | mg/dl | Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op. |
|
|
|
| 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. | The numbers of participants listed for renal function demonstrated the number of participants tested. | Posted | Mean | Standard Deviation | mL/min/1.73 m² | Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op. |
|
|
|
| 4 |
| 83 |
| 25 |
| 83 |
| 62 |
| 83 |
| Oncological events | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Neurological events | Nervous system disorders | Systematic Assessment |
|
| Cardiovascular events | Cardiac disorders | Systematic Assessment |
|
| Musculoskeletal (non-hip) events | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dermatological events | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pulmonary/Respiratory events | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Infection (hip), superficial | Infections and infestations | Systematic Assessment |
|
| Gastrointestinal events | Gastrointestinal disorders | Systematic Assessment |
|
| Delayed Wound Healing | Surgical and medical procedures | Systematic Assessment |
|
| Instability | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hematoma | Blood and lymphatic system disorders | Systematic Assessment |
|
| Endocrine | Endocrine disorders | Systematic Assessment |
|
| Infection (non-hip) | Infections and infestations | Systematic Assessment |
|
| ENT | Ear and labyrinth disorders | Systematic Assessment |
|
| Dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Other Hip Related Radiographic Finding | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Other General Complication | General disorders | Systematic Assessment |
|
| Thigh/Groin/Hip Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
|
| Genitourinary / Renal | Renal and urinary disorders | Systematic Assessment |
|
| Other Hip Related Radiographic Finding | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neurological | Nervous system disorders | Systematic Assessment |
|
| Pulmonary/Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
|
| 6-month |
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| 1-year |
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| 2-year |
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| 3-year |
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| 5-year |
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| 7-year |
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| 10-year |
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| 6-month SF-12 (Physical) |
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| 1-year SF-12 (Physical) |
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| 2-year SF-12 (Physical) |
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| 3-year SF-12 (Physical) |
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| 5-year SF-12 (Physical) |
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| 7-year SF-12 (Physical) |
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| 10-year SF-12 (Physical) |
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| Preop SF-12 (Mental) |
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| 6-week SF-12 (Mental) |
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| 6-month SF-12 (Mental) |
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| 1-year SF-12 (Mental) |
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| 2-year SF-12 (Mental) |
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| 3-year SF-12 (Mental) |
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| 5-year SF-12 (Mental) |
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| 7-year SF-12 (Mental) |
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| 10-year SF-12 (Mental) |
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| Title | Measurements |
|---|---|
|
| Other |
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| Immed-postop |
|
| 6-week |
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| 6-month |
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| 1-year |
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| 2-year |
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| 3-year |
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| 5-year |
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| 7-year |
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| 10-year |
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| 1-year (Chromium) |
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| 2-year (Chromium) |
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| 5-year (Chromium) |
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| Preop (Cobalt) |
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| 6-Month (Cobalt) |
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| 1-year (Cobalt) |
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| 2-year (Cobalt) |
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| 5-year (Cobalt) |
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| Preop (Titanium) |
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| 6-month (Titanium) |
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| 1-year (Titanium) |
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| 2-year (Titanium) |
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| 5-year (Titanium) |
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| 6-month EQ-5D-5L |
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| 1-year EQ-5D-5L |
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| 2-year EQ-5D-5L |
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| 3-year EQ-5D-5L |
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| 5-year EQ-5D-5L |
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| 7-year EQ-5D-5L |
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| 10-year EQ-5D-5L |
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| 1-year (Creatine) |
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| 2-year (Creatine) |
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| 5-year (Creatine) |
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| Preop (BUN) |
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| 6-month (BUN) |
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| 1-year (BUN) |
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| 2-year (BUN) |
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| 5-year (BUN) |
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| 1-year (GRF) |
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| 2-year (GRF) |
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| 5-year (GRF) |
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