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The primary purpose of this study is to evaluate the clinical performance of the Arcos Revision Stem system, determine the stability of the implants, and evaluate any relationship between Paprosky bone defect level and the success of the Arcos Stem.
Primary Endpoint: survivorship and revision rate up to 5 years post-operatively Secondary Endpoints: Stability and Fixation of Arcos Hip by radiographic assessment, Relationship between bone defect level and survivorship, Oxford Hip Score and Harris Hip Score post-operative, Adverse events, complications.
Case Report Forms: Demographic Data, Paprosky Acetabular/Femoral Defects, Operative Data, Oxford Hip Score, Harris Hip Score, Collection of X-rays, Radiographic Evaluation form, Adverse Events, Revisions, Lost to Follow-up, and Protocol Deviations
200 patients: 100 with BoneMaster HA, 100 without BoneMaster HA. Up to 10 sites globally will be used to fulfill enrollment in this study.
All cases enrolled will be those implanted with either the Cone, Broached, or Calcar Proximal Body and one of the five distal options (Slotted, Bullet-tip, Interlocking, STS, or ETO).
To be included in the study, a patient must have received a revision total hip arthroplasty with the Arcos system. The Arcos system is to be used in accordance to the indications for use and contraindications detailed in the approved labeling of the device.
Study time perspective:
Collection of retrospective data in supplement to the data collected in the course of the prospective study to compensate total enrolment goal. This is applicable for 3 sites: Finland, United Kingdom (NHS Sheffield), Spain.
All patients enrolled in the study will be followed up as to the same time points for the duration of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With Bonemaster HA | 100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arcos Revision Stem System | Device | Revision Hip System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship | The primary endpoint for this study was implant survival at 5 years post surgery and is presented by the number of cases with the implants unrevised | 5 year post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Evaluation | This outcome measure was to evaluate the stability and fixation of the Arcos hip stem. This was done through radiographic measurements of stability and fixation, outcome, incidence of radiolucencies around the stem. Acetabular radiolucency was also assessed. | 6 weeks, 1 year, 3 years and 5 years Post Surgery |
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Inclusion Criteria:
The Arcos™ Modular Femoral Revision System hip components are single-use implants, intended for uncemented use only.
Only subjects who have received or have already been scheduled to receive hip surgery with the Arcos Revision Stem System will be included in this outcomes study.
Additional Inclusion Criteria:
Exclusion Criteria:
Absolute contraindications include: active infection, sepsis, and osteomyelitis.
Relative contraindications include:
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The study population will include patients who had a revision to a total hip replacement using the Arcos Revision Stem Hip System.
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Achakri | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital | Turku | Finland | ||||
| Hospital Universitari Mutua |
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After checking the operative records for the prospective and retrospectively enrolled cases, only 74 cases were eligible to be included in the study.
In total, 74 cases who received the Arcos hip stem were evaluated at 5 study centers in Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | With Bonemaster HA | 100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite Arcos Revision Stem System: Revision Hip System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
74 cases who were eligible to be included in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | With Bonemaster HA | Patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite Arcos Revision Stem System: Revision Hip System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Survivorship | The primary endpoint for this study was implant survival at 5 years post surgery and is presented by the number of cases with the implants unrevised | All study patients | Posted | Count of Participants | Participants | 5 year post surgery |
|
|
Operative, 6 Weeks, 1 Year, 3 Years and 5 Years
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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 | With Bonemaster HA | 100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite Arcos Revision Stem System: Revision Hip System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Infection | Musculoskeletal and connective tissue disorders | Systematic Assessment | Deep infection < 6 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General Complications | Infections and infestations | Systematic Assessment | Respiratory infection, Urinary tract infection and infection |
The study was initially set up to collect data within two study arms (100 with BoneMaster HA and 100 without BoneMaster HA) globally including up to ten sites. However, the study only ended up enrolling 74 cases with BoneMaster in EMEA across 5 study sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Meijer | Zimmer Biomet | +31 6 57933741 | linda.meijer@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 | Mar 15, 2015 | Nov 28, 2024 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| D000013 | Congenital Abnormalities |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| EQ5D |
The EuroQol 5 Dimension (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, selfcare, 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. The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. The Visual Analogue Scale (VAS) is a vertical scale ranges from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her self-rated health. |
| Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery |
| 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 Score ranges from 0 - 100 and the outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27. | Preop, 6 weeks, 1 year, 3 years and 5 years post surgery |
| Harris Hip Score | 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. | Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery |
| Barcelona |
| Spain |
| Uddevalla Hospital | Uddevalla | Sweden |
| Hinchingbrooke Hosptial | Cambridge | United Kingdom |
| NHS - Sheffield Teaching Hospital | Sheffield | United Kingdom |
| Participants |
|
| 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 | Standard Deviation | kg/m2 |
|
|
| Secondary | Radiographic Evaluation | This outcome measure was to evaluate the stability and fixation of the Arcos hip stem. This was done through radiographic measurements of stability and fixation, outcome, incidence of radiolucencies around the stem. Acetabular radiolucency was also assessed. | Acetabular and femoral radiolucency was analysed for all study patients for different zones at the outcome measure time frames listed above. The numbers listed below in the count of participants is the number of cases where radiolucency was seen on their X-ray images in different zones and at different follow up time points. | Posted | Count of Participants | Participants | 6 weeks, 1 year, 3 years and 5 years Post Surgery |
|
|
|
| Secondary | EQ5D | The EuroQol 5 Dimension (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, selfcare, 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. The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. The Visual Analogue Scale (VAS) is a vertical scale ranges from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her self-rated health. | All study patients. | Posted | Mean | Standard Deviation | score on a scale | Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery |
|
|
|
| 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 Score ranges from 0 - 100 and the outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27. | All study patients | Posted | Mean | Standard Deviation | score on a scale | Preop, 6 weeks, 1 year, 3 years and 5 years post surgery |
|
|
|
| Secondary | Harris Hip Score | 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 | Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery |
|
|
|
| 8 |
| 74 |
| 28 |
| 74 |
| 13 |
| 74 |
|
| Dislocation and Sublaxation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Dislocation |
|
| Femoral Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Femoral Pain |
|
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Fracture of femoral shaft and trochanter |
|
| Hematoma | Musculoskeletal and connective tissue disorders | Systematic Assessment | Hematoma |
|
| Instability | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nerve and vascular deficit | Musculoskeletal and connective tissue disorders | Systematic Assessment | Nerve and vascular deficit |
|
| Superficial Infection | Musculoskeletal and connective tissue disorders | Systematic Assessment | Superficial Infection |
|
| Wound Drainage and Dehiscence | Musculoskeletal and connective tissue disorders | Systematic Assessment | Wound Drainage and Dehiscence |
|
| Other Hip Related Adverse Events | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain, trochanteric bolt loosening, contralateral hip surgery, leg reddening, hip athrosis, wound secretion |
|
|
| General Complications | Nervous system disorders | Systematic Assessment | Nerve injury and stroke |
|
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| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014947 | Wounds and Injuries |
|
| Acetabular Radiolucency, 6 Weeks Zone 3 |
|
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| Acetabular Radiolucency, 1 Year Zone 1 |
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| Acetabular Radiolucency, 1 Year Zone 2 |
|
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| Acetabular Radiolucency, 1 Year Zone 3 |
|
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| Acetabular Radiolucency, 3 Year Zone 1 |
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| Acetabular Radiolucency, 3 Year Zone 2 |
|
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| Acetabular Radiolucency, 3 Year Zone 3 |
|
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| Acetabular Radiolucency, 5 Year Zone 1 |
|
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| Acetabular Radiolucency, 5 Year Zone 2 |
|
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| Acetabular Radiolucency, 5 Year Zone 3 |
|
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| Femoral AP View Radiolucency, 6 Weeks Zone 1 |
|
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| Femoral AP View Radiolucency, 6 Weeks Zone 2 |
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| Femoral AP View Radiolucency, 6 Weeks Zone 3 |
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| Femoral AP View Radiolucency, 6 Weeks Zone 5 |
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| Femoral AP View Radiolucency, 6 Weeks Zone 6 |
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| Femoral AP View Radiolucency, 6 Weeks Zone 7 |
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| Femoral AP View Radiolucency, 1 Year Zone 1 |
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| Femoral AP View Radiolucency, 1 Year Zone 2 |
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| Femoral AP View Radiolucency, 1 Year Zone 3 |
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| Femoral AP View Radiolucency, 1 Year Zone 4 |
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| Femoral AP View Radiolucency, 1 Year Zone 5 |
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| Femoral AP View Radiolucency, 1 Year Zone 6 |
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| Femoral AP View Radiolucency, 1 Year Zone 7 |
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| Femoral AP View Radiolucency, 3 Years Zone 1 |
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| Femoral AP View Radiolucency, 3 Years Zone 2 |
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| Femoral AP View Radiolucency, 3 Years Zone 3 |
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| Femoral AP View Radiolucency, 3 Years Zone 5 |
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| Femoral AP View Radiolucency, 3 Years Zone 6 |
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| Femoral AP View Radiolucency, 3 Years Zone 7 |
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| Femoral AP View Radiolucency, 5 Years Zone 1 |
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| Femoral AP View Radiolucency, 5 Years Zone 2 |
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| Femoral AP View Radiolucency, 5 Years Zone 3 |
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| Femoral AP View Radiolucency, 5 Years Zone 5 |
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| Femoral AP View Radiolucency, 5 Years Zone 6 |
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| Femoral AP View Radiolucency, 5 Years Zone 7 |
|
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| Femoral Lateral View Radiolucency, 6 Weeks Zone 8 |
|
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| Femoral Lateral View Radiolucency, 6 Weeks Zone 9 |
|
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| Femoral Lateral View Radiolucency, 6 Weeks Zone 10 |
|
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| Femoral Lateral View Radiolucency, 6 Weeks Zone 12 |
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| Femoral Lateral View Radiolucency, 6 Weeks Zone 13 |
|
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| Femoral Lateral View Radiolucency, 6 Weeks Zone 14 |
|
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| Femoral Lateral View Radiolucency, 1 Year Zone 8 |
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| Femoral Lateral View Radiolucency, 1 Year Zone 9 |
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| Femoral Lateral View Radiolucency, 1 Year Zone 10 |
|
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| Femoral Lateral View Radiolucency, 1 Year Zone 11 |
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| Femoral Lateral View Radiolucency, 1 Year Zone 12 |
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| Femoral Lateral View Radiolucency, 1 Year Zone 13 |
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| Femoral Lateral View Radiolucency, 1 Year Zone 14 |
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| Femoral Lateral View Radiolucency, 3 Years Zone 8 |
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| Femoral Lateral View Radiolucency, 3 Years Zone 9 |
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| Femoral Lateral View Radiolucency, 3 Years Zone 10 |
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| Femoral Lateral View Radiolucency, 3 Years Zone 12 |
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| Femoral Lateral View Radiolucency, 3 Years Zone 13 |
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| Femoral Lateral View Radiolucency, 3 Years Zone 14 |
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| Femoral Lateral View Radiolucency, 5 Years Zone 8 |
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| Femoral Lateral View Radiolucency, 5 Years Zone 9 |
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| Femoral Lateral View Radiolucency, 5 Years Zone 10 |
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| Femoral Lateral View Radiolucency, 5 Years Zone 12 |
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| Femoral Lateral View Radiolucency, 5 Years Zone 13 |
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| Femoral Lateral View Radiolucency, 5 Years Zone 14 |
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| 1 Year EQ-5D |
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| 3 Years EQ-5D |
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| 5 Years EQ-5D |
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| 1 Year Oxford Hip Score |
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| 3 Years Oxford Hip Score |
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| 5 Years Oxford Hip Score |
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| 1 Year Harris Hip Score |
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| 3 Years Harris Hip Score |
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| 5 Years Harris Hip Score |
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