An observational study in Osteoarthritis, Avascular Necrosis and Rheumatoid Arthritis, sponsored by Zimmer Biomet. Completed at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by Zimmer Biomet · Observational
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.
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 74 is below the median of 100 across 803 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will include patients who had a revision to a total hip replacement using the Arcos Revision Stem Hip System.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite
Device: Arcos Revision Stem System
Revision Hip System
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
Time frame: 5 year post surgery
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.
Time frame: 6 weeks, 1 year, 3 years and 5 years Post Surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery
In total, 74 cases who received the Arcos hip stem were evaluated at 5 study centers in Europe.
| Milestone | With Bonemaster HA |
|---|---|
| Started | 74 |
| Completed | 56 |
| Not completed | 18 |
| Withdrew: Death | 8 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 9 |
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
| Participants | With Bonemaster HA |
|---|---|
| Survivorship | 74 |
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.
| Participants | With Bonemaster HA |
|---|---|
| Number of patients with Acetabular Radiolucency seen in their Xray images, 6 Weeks Zone 1 | 9 |
| Acetabular Radiolucency, 6 Weeks Zone 2 | 4 |
| Acetabular Radiolucency, 6 Weeks Zone 3 | 1 |
| Acetabular Radiolucency, 1 Year Zone 1 | 12 |
| Acetabular Radiolucency, 1 Year Zone 2 | 5 |
| Acetabular Radiolucency, 1 Year Zone 3 | 8 |
| Acetabular Radiolucency, 3 Year Zone 1 | 13 |
| Acetabular Radiolucency, 3 Year Zone 2 | 4 |
| Acetabular Radiolucency, 3 Year Zone 3 | 7 |
| Acetabular Radiolucency, 5 Year Zone 1 | 10 |
| Acetabular Radiolucency, 5 Year Zone 2 | 4 |
| Acetabular Radiolucency, 5 Year Zone 3 | 7 |
| Femoral AP View Radiolucency, 6 Weeks Zone 1 | 6 |
| Femoral AP View Radiolucency, 6 Weeks Zone 2 | 10 |
| Femoral AP View Radiolucency, 6 Weeks Zone 3 | 4 |
| Femoral AP View Radiolucency, 6 Weeks Zone 5 | 4 |
| Femoral AP View Radiolucency, 6 Weeks Zone 6 | 7 |
| Femoral AP View Radiolucency, 6 Weeks Zone 7 | 9 |
| Femoral AP View Radiolucency, 1 Year Zone 1 | 14 |
| Femoral AP View Radiolucency, 1 Year Zone 2 | 9 |
| Femoral AP View Radiolucency, 1 Year Zone 3 | 6 |
| Femoral AP View Radiolucency, 1 Year Zone 4 | 1 |
| Femoral AP View Radiolucency, 1 Year Zone 5 | 2 |
| Femoral AP View Radiolucency, 1 Year Zone 6 | 7 |
| Femoral AP View Radiolucency, 1 Year Zone 7 | 11 |
| Femoral AP View Radiolucency, 3 Years Zone 1 | 16 |
| Femoral AP View Radiolucency, 3 Years Zone 2 | 5 |
| Femoral AP View Radiolucency, 3 Years Zone 3 | 3 |
| Femoral AP View Radiolucency, 3 Years Zone 5 | 6 |
| Femoral AP View Radiolucency, 3 Years Zone 6 | 7 |
| Femoral AP View Radiolucency, 3 Years Zone 7 | 13 |
| Femoral AP View Radiolucency, 5 Years Zone 1 | 9 |
| Femoral AP View Radiolucency, 5 Years Zone 2 | 4 |
| Femoral AP View Radiolucency, 5 Years Zone 3 | 3 |
| Femoral AP View Radiolucency, 5 Years Zone 5 | 0.0 |
| Femoral AP View Radiolucency, 5 Years Zone 6 | 2 |
| Femoral AP View Radiolucency, 5 Years Zone 7 | 7 |
| Femoral Lateral View Radiolucency, 6 Weeks Zone 8 | 12 |
| Femoral Lateral View Radiolucency, 6 Weeks Zone 9 | 9 |
| Femoral Lateral View Radiolucency, 6 Weeks Zone 10 | 3 |
| Femoral Lateral View Radiolucency, 6 Weeks Zone 12 | 3 |
| Femoral Lateral View Radiolucency, 6 Weeks Zone 13 | 7 |
| Femoral Lateral View Radiolucency, 6 Weeks Zone 14 | 6 |
| Femoral Lateral View Radiolucency, 1 Year Zone 8 | 19 |
| Femoral Lateral View Radiolucency, 1 Year Zone 9 | 9 |
| Femoral Lateral View Radiolucency, 1 Year Zone 10 | 4 |
| Femoral Lateral View Radiolucency, 1 Year Zone 11 | 1 |
| Femoral Lateral View Radiolucency, 1 Year Zone 12 | 3 |
| Femoral Lateral View Radiolucency, 1 Year Zone 13 | 10 |
| Femoral Lateral View Radiolucency, 1 Year Zone 14 | 9 |
| Femoral Lateral View Radiolucency, 3 Years Zone 8 | 12 |
| Femoral Lateral View Radiolucency, 3 Years Zone 9 | 7 |
| Femoral Lateral View Radiolucency, 3 Years Zone 10 | 5 |
| Femoral Lateral View Radiolucency, 3 Years Zone 12 | 4 |
| Femoral Lateral View Radiolucency, 3 Years Zone 13 | 7 |
| Femoral Lateral View Radiolucency, 3 Years Zone 14 | 8 |
| Femoral Lateral View Radiolucency, 5 Years Zone 8 | 10 |
| Femoral Lateral View Radiolucency, 5 Years Zone 9 | 3 |
| Femoral Lateral View Radiolucency, 5 Years Zone 10 | 1 |
| Femoral Lateral View Radiolucency, 5 Years Zone 12 | 2 |
| Femoral Lateral View Radiolucency, 5 Years Zone 13 | 3 |
| Femoral Lateral View Radiolucency, 5 Years Zone 14 | 4 |
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.
| score on a scale | With Bonemaster HA |
|---|---|
| Preop EQ-5D | 0.3 ± 0.4 |
| 6 Weeks EQ-5D | 0.6 ± 0.2 |
| 1 Year EQ-5D | 0.7 ± 0.3 |
| 3 Years EQ-5D | 0.7 ± 0.3 |
| 5 Years EQ-5D | 0.8 ± 0.2 |
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.
| score on a scale | With Bonemaster HA |
|---|---|
| Preop Oxford Hip Score | 18.8 ± 8.6 |
| 6 Weeks Oxford Hip Score | 28.3 ± 8.8 |
| 1 Year Oxford Hip Score | 34.4 ± 10.9 |
| 3 Years Oxford Hip Score | 36.9 ± 10.5 |
| 5 Years Oxford Hip Score | 39.3 ± 8.6 |
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.
| score on a scale | With Bonemaster HA |
|---|---|
| Preop Harris Hip Score | 41.3 ± 15.6 |
| 6 Weeks Harris Hip Score | 60.0 ± 15.3 |
| 1 Year Harris Hip Score | 73.0 ± 21.3 |
| 3 Years Harris Hip Score | 78.3 ± 19.1 |
| 5 Years Harris Hip Score | 79.8 ± 16.8 |
Collected over Operative, 6 Weeks, 1 Year, 3 Years and 5 Years. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| With Bonemaster HA | 8/74 (10.8%) | 28/74 (37.8%) | 13/74 (17.6%) |
| Event | With Bonemaster HA |
|---|---|
| Other Hip Related Adverse EventsMusculoskeletal and connective tissue disorders | 12/74 |
| Wound Drainage and DehiscenceMusculoskeletal and connective tissue disorders | 5/74 |
| Deep InfectionMusculoskeletal and connective tissue disorders | 3/74 |
| Dislocation and SublaxationMusculoskeletal and connective tissue disorders | 3/74 |
| FractureMusculoskeletal and connective tissue disorders | 3/74 |
| Femoral PainMusculoskeletal and connective tissue disorders | 2/74 |
| Nerve and vascular deficitMusculoskeletal and connective tissue disorders | 2/74 |
| HematomaMusculoskeletal and connective tissue disorders | 1/74 |
| InstabilityMusculoskeletal and connective tissue disorders | 1/74 |
| Superficial InfectionMusculoskeletal and connective tissue disorders | 1/74 |
| Event | With Bonemaster HA |
|---|---|
| General ComplicationsInfections and infestations | 9/74 |
| General ComplicationsNervous system disorders | 4/74 |
74 cases who were eligible to be included in the study.
| Age, Categorical(Participants) | With Bonemaster HA |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 22 |
| >=65 years | 52 |
| Sex: Female, Male(Participants) | With Bonemaster HA |
|---|---|
| Female | 38 |
| Male | 36 |
| Race and Ethnicity Not Collected(Participants) | With Bonemaster HA |
|---|
| Region of Enrollment(participants) | With Bonemaster HA |
|---|---|
| Sweden | 19 |
| Finland | 15 |
| United Kingdom | 22 |
| Spain | 18 |
| BMI(kg/m2) | With Bonemaster HA |
|---|---|
| Mean | 29.2 ± 6.4 |
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