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The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup.
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate, as defined in the protocol, at 2 year postoperative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceramic On Metal | Experimental | This arm utilizes the ceramic on metal articulation using the M2a-38™ mm cup. |
|
| Metal on Metal | Active Comparator | This arm utilizes the metal on metal articulation using M2a-38™ mm cup. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceramic On Metal | Device | Ceramic on Metal articulation using M2a-38™ mm cup |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Clinical Success (CCS) Rate as Defined in the Protocol | CCS is defined as: a. Total Harris Hip Score > 80 points, and b. No acetabular or femoral revision or removal, and c. No pending acetabular or femoral revision or removal as defined in radiographic evaluation by: i. An acetabular radiographic assessment with all of the following:
1. Subsidence < 5 mm, and 2. Absence of osteolysis. The HHS including a series of questions answered by the patient and physical examinations recorded by a qualified health care professional 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). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70 | 2 years post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Hip Score | The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| G. Stranks, FRCS | North Hampshire Hospital | Principal Investigator |
| M Pesola | Central Finland Hospital District | Principal Investigator |
| H Kauppinen | Kymenlaakso Central Hospital Kotka Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Finland Central Hospital | Jyväskylä | Finland | ||||
| Kymenlaakso Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31540737 | Derived | Higgins JE, Conn KS, Britton JM, Pesola M, Manninen M, Stranks GJ. Early Results of Our International, Multicenter, Multisurgeon, Double-Blinded, Prospective, Randomized, Controlled Trial Comparing Metal-on-Metal With Ceramic-on-Metal in Total Hip Arthroplasty. J Arthroplasty. 2020 Jan;35(1):193-197.e2. doi: 10.1016/j.arth.2019.08.002. Epub 2019 Aug 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceramic On Metal | Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head. |
| FG001 | Metal on Metal | Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ceramic On Metal | Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head. |
| BG001 | Metal on Metal | Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age (years) at date of surgery |
| 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 | Composite Clinical Success (CCS) Rate as Defined in the Protocol | CCS is defined as: a. Total Harris Hip Score > 80 points, and b. No acetabular or femoral revision or removal, and c. No pending acetabular or femoral revision or removal as defined in radiographic evaluation by: i. An acetabular radiographic assessment with all of the following:
1. Subsidence < 5 mm, and 2. Absence of osteolysis. The HHS including a series of questions answered by the patient and physical examinations recorded by a qualified health care professional 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). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70 | Due to a lack of radiographic evaluation data, the overall number of participants analyzed is smaller than the actual number enrolled. | Posted | Count of Participants | Participants | 2 years post-operatively |
From surgery until the last study visit at 10 years post-op.
ISO definitions are applicable. 211 operative cases (110 COM and 101 MOM) were available for the analysis.
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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 | Ceramic On Metal | Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision | Surgical and medical procedures | Systematic Assessment | One or more components revised |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Lead | Zimmer Biomet | +31 62 395 6378 | lisette.smid@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 | Sep 23, 2008 | Jun 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D061825 | Metal-on-Metal Joint Prostheses |
| ID | Term |
|---|---|
| D007595 | Joint Prosthesis |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Metal on Metal |
| Device |
Metal on Metal articulation using M2a-38™ mm cup |
|
| pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively |
| Womac Score | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score) is a standardised patient reported outcome measure consisting of 24 items divided into 3 sub-sections: Pain (5 items), stiffness (2 items) and physical function or "Activities of Daily Living; ADL" (17 items). A higher score indicates a worse clinical outcome. The maximum score for each subsection is Pain: 20 - 0; Stiffness: 8 - 0; ADL: 68 - 0. | pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively |
| Metal Ion Concentrations in Blood | Chromium and Cobalt concentrations in blood are measured in measurement unit nmol/L. The change from baseline analysis is presented. | 6 months post-operatively, 1, 2, 3 and 5 years post-operatively |
| Survivorship | Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 10 years post-operative is presented here. | 10 years post-op |
| Kotka |
| Finland |
| North Hampshire Hospital | Basingstoke | RG24 9NA | United Kingdom |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| 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 |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Ceramic On Metal | Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head. |
| OG001 | Metal on Metal | Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head. |
|
|
| Secondary | Oxford Hip Score | The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27. | 2 patients were not included in analysis due to receiving a different articulation (not the study device). Other than that, the number of participants decreased over time due to several reasons, such as missing visits or lost to follow-up or withdrawn from the study for any reason. | Posted | Mean | Standard Deviation | units on a scale | pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively |
|
|
|
| Secondary | Womac Score | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score) is a standardised patient reported outcome measure consisting of 24 items divided into 3 sub-sections: Pain (5 items), stiffness (2 items) and physical function or "Activities of Daily Living; ADL" (17 items). A higher score indicates a worse clinical outcome. The maximum score for each subsection is Pain: 20 - 0; Stiffness: 8 - 0; ADL: 68 - 0. | 2 patients were not included in analysis due to receiving a different articulation (not the study device). Other than that, the number of participants decreased over time due to several reasons, such as missing visits or lost to follow-up or withdrawn from the study for any reason. | Posted | Mean | Standard Deviation | Units on a scale | pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively |
|
|
|
| Secondary | Metal Ion Concentrations in Blood | Chromium and Cobalt concentrations in blood are measured in measurement unit nmol/L. The change from baseline analysis is presented. | Metal Ion analysis is only performed on a subset of the patients. Other than that, the number of participants fluctuates over time due to several reasons, such as missing visits or lost to follow-up or withdrawn from the study for any reason. | Posted | Mean | Standard Deviation | nmol/l | 6 months post-operatively, 1, 2, 3 and 5 years post-operatively |
|
|
|
| Secondary | Survivorship | Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 10 years post-operative is presented here. | Posted | Count of Participants | Participants | 10 years post-op |
|
|
|
| 16 |
| 110 |
| 35 |
| 110 |
| 0 |
| 110 |
| EG001 | Metal on Metal | Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head. | 13 | 101 | 38 | 101 | 0 | 101 |
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| Cancer | General disorders | Systematic Assessment |
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| Cardiovascular problems | Cardiac disorders | Systematic Assessment |
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| Muculoskeletal problems | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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| 6 weeks postoperative |
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| 6 months postoperative |
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| 1 year postoperative |
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| 2 years postoperative |
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| 3 years postoperative |
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| 4 years postoperative |
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| 5 years postoperative |
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| 10 years postoperative |
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| Pain 6 weeks post-operatively |
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| Pain 6 months post-operatively |
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| Pain 1 year post-operatively |
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| Pain 2 year post-operatively |
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| Pain 3 year post-operatively |
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| Pain 4 year post-operatively |
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| Pain 5 year post-operatively |
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| Pain 10 year post-operatively |
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| Stiffness pre-operatively |
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| Stiffness 6 weeks post-operatively |
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| Stiffness 6 months post-operatively |
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| Stiffness 1 year post-operatively |
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| Stiffness 2 year post-operatively |
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| Stiffness 3 year post-operatively |
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| Stiffness 4 year post-operatively |
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| Stiffness 5 year post-operatively |
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| Stiffness 10 year post-operatively |
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| ADL pre-operatively |
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| ADL 6 weeks post-operatively |
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| ADL 6 months post-operatively |
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| ADL 1 year post-operatively |
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| ADL 2 year post-operatively |
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| ADL 3 year post-operatively |
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| ADL 4 year post-operatively |
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| ADL 5 year post-operatively |
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| ADL 10 year post-operatively |
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| Chromium 1 year |
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| Chromium 2 years |
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| Chromium 3 years |
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| Chromium 5 years |
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| Cobalt 6 months |
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| Cobalt 1 year |
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| Cobalt 2 years |
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| Cobalt 3 years |
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| Cobalt 5 years |
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