Avascular Necrosis, Complications; Arthroplasty, Deformity, Fracture, Osteoarthritis, Rheumatoid Arthritis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEArcos Revision Stem System
Revision Hip System
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis * Rheumatoid arthritis * Correction of functional deformity * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. * Revision of previously failed total hip arthroplasty. 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: * No age limit, however, the patient must have reached full skeletal maturity. * Willing to return for follow up evaluation.
Exclusion criteria
Absolute contraindications include: active infection, sepsis, and osteomyelitis. Relative contraindications include: * Uncooperative patient or patient with neurologic disorders who are incapable of following directions * Osteoporosis * Metabolic disorders which may impair bone formation * Osteomalacia * Distant foci of infections which may spread to the implant site * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * Vascular insufficiency, muscular atrophy, or neuromuscular disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship | 5 year post surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Evaluation | 6 weeks, 1 year, 3 years and 5 years Post Surgery | 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. |
| EQ5D | Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery | 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. |
| Oxford Hip Score | Preop, 6 weeks, 1 year, 3 years and 5 years post surgery | 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. |
| Harris Hip Score | Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery | 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. |
Countries
Finland, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
In total, 74 cases who received the Arcos hip stem were evaluated at 5 study centers in Europe.
Pre-assignment details
After checking the operative records for the prospective and retrospectively enrolled cases, only 74 cases were eligible to be included in the study.
Participants by arm
| Arm | Count |
|---|---|
| With Bonemaster HA Patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite
Arcos Revision Stem System: Revision Hip System | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 8 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | With Bonemaster HA | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 52 Participants | — |
| Age, Categorical Between 18 and 65 years | 22 Participants | — |
| BMI | 29.2 kg/m2 STANDARD_DEVIATION 6.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Finland | 15 participants | — |
| Region of Enrollment Spain | 18 participants | — |
| Region of Enrollment Sweden | 19 participants | — |
| Region of Enrollment United Kingdom | 22 participants | — |
| Sex: Female, Male Female | 38 Participants | — |
| Sex: Female, Male Male | 36 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 74 |
| other Total, other adverse events | 13 / 74 |
| serious Total, serious adverse events | 28 / 74 |
Outcome results
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
Time frame: 5 year post surgery
Population: All study patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| With Bonemaster HA | Survivorship | 74 Participants |
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.
Time frame: Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery
Population: All study patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| With Bonemaster HA | EQ5D | 1 Year EQ-5D | 0.7 score on a scale | Standard Deviation 0.3 |
| With Bonemaster HA | EQ5D | 3 Years EQ-5D | 0.7 score on a scale | Standard Deviation 0.3 |
| With Bonemaster HA | EQ5D | Preop EQ-5D | 0.3 score on a scale | Standard Deviation 0.4 |
| With Bonemaster HA | EQ5D | 6 Weeks EQ-5D | 0.6 score on a scale | Standard Deviation 0.2 |
| With Bonemaster HA | EQ5D | 5 Years EQ-5D | 0.8 score on a scale | Standard Deviation 0.2 |
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.
Time frame: Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgery
Population: All study patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| With Bonemaster HA | Harris Hip Score | Preop Harris Hip Score | 41.3 score on a scale | Standard Deviation 15.6 |
| With Bonemaster HA | Harris Hip Score | 6 Weeks Harris Hip Score | 60.0 score on a scale | Standard Deviation 15.3 |
| With Bonemaster HA | Harris Hip Score | 1 Year Harris Hip Score | 73.0 score on a scale | Standard Deviation 21.3 |
| With Bonemaster HA | Harris Hip Score | 3 Years Harris Hip Score | 78.3 score on a scale | Standard Deviation 19.1 |
| With Bonemaster HA | Harris Hip Score | 5 Years Harris Hip Score | 79.8 score on a scale | Standard Deviation 16.8 |
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.
Time frame: Preop, 6 weeks, 1 year, 3 years and 5 years post surgery
Population: All study patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| With Bonemaster HA | Oxford Hip Score | Preop Oxford Hip Score | 18.8 score on a scale | Standard Deviation 8.6 |
| With Bonemaster HA | Oxford Hip Score | 6 Weeks Oxford Hip Score | 28.3 score on a scale | Standard Deviation 8.8 |
| With Bonemaster HA | Oxford Hip Score | 1 Year Oxford Hip Score | 34.4 score on a scale | Standard Deviation 10.9 |
| With Bonemaster HA | Oxford Hip Score | 3 Years Oxford Hip Score | 36.9 score on a scale | Standard Deviation 10.5 |
| With Bonemaster HA | Oxford Hip Score | 5 Years Oxford Hip Score | 39.3 score on a scale | Standard Deviation 8.6 |
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.
Time frame: 6 weeks, 1 year, 3 years and 5 years Post Surgery
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 5 Years Zone 14 | 4 Participants |
| With Bonemaster HA | Radiographic Evaluation | Acetabular Radiolucency, 5 Year Zone 2 | 4 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 5 Years Zone 9 | 3 Participants |
| With Bonemaster HA | Radiographic Evaluation | Number of patients with Acetabular Radiolucency seen in their Xray images, 6 Weeks Zone 1 | 9 Participants |
| With Bonemaster HA | Radiographic Evaluation | Acetabular Radiolucency, 6 Weeks Zone 2 | 4 Participants |
| With Bonemaster HA | Radiographic Evaluation | Acetabular Radiolucency, 6 Weeks Zone 3 | 1 Participants |
| With Bonemaster HA | Radiographic Evaluation | Acetabular Radiolucency, 1 Year Zone 1 | 12 Participants |
| With Bonemaster HA | Radiographic Evaluation | Acetabular Radiolucency, 1 Year Zone 2 | 5 Participants |
| With Bonemaster HA | Radiographic Evaluation | Acetabular Radiolucency, 1 Year Zone 3 | 8 Participants |
| With Bonemaster HA | Radiographic Evaluation | Acetabular Radiolucency, 3 Year Zone 1 | 13 Participants |
| With Bonemaster HA | Radiographic Evaluation | Acetabular Radiolucency, 3 Year Zone 2 | 4 Participants |
| With Bonemaster HA | Radiographic Evaluation | Acetabular Radiolucency, 3 Year Zone 3 | 7 Participants |
| With Bonemaster HA | Radiographic Evaluation | Acetabular Radiolucency, 5 Year Zone 1 | 10 Participants |
| With Bonemaster HA | Radiographic Evaluation | Acetabular Radiolucency, 5 Year Zone 3 | 7 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 6 Weeks Zone 1 | 6 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 6 Weeks Zone 2 | 10 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 6 Weeks Zone 3 | 4 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 6 Weeks Zone 5 | 4 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 6 Weeks Zone 6 | 7 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 6 Weeks Zone 7 | 9 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 1 Year Zone 1 | 14 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 1 Year Zone 2 | 9 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 1 Year Zone 3 | 6 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 1 Year Zone 4 | 1 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 1 Year Zone 5 | 2 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 1 Year Zone 6 | 7 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 1 Year Zone 7 | 11 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 3 Years Zone 1 | 16 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 3 Years Zone 2 | 5 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 3 Years Zone 3 | 3 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 3 Years Zone 5 | 6 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 3 Years Zone 6 | 7 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 5 Years Zone 10 | 1 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 5 Years Zone 12 | 2 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 3 Years Zone 7 | 13 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 5 Years Zone 1 | 9 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 5 Years Zone 2 | 4 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 5 Years Zone 3 | 3 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 5 Years Zone 5 | 0.0 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 5 Years Zone 6 | 2 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral AP View Radiolucency, 5 Years Zone 7 | 7 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 6 Weeks Zone 8 | 12 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 6 Weeks Zone 9 | 9 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 6 Weeks Zone 10 | 3 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 6 Weeks Zone 12 | 3 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 6 Weeks Zone 13 | 7 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 6 Weeks Zone 14 | 6 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 1 Year Zone 8 | 19 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 1 Year Zone 9 | 9 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 1 Year Zone 10 | 4 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 1 Year Zone 11 | 1 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 1 Year Zone 12 | 3 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 1 Year Zone 13 | 10 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 1 Year Zone 14 | 9 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 3 Years Zone 8 | 12 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 3 Years Zone 9 | 7 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 3 Years Zone 10 | 5 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 5 Years Zone 13 | 3 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 3 Years Zone 12 | 4 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 3 Years Zone 13 | 7 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 3 Years Zone 14 | 8 Participants |
| With Bonemaster HA | Radiographic Evaluation | Femoral Lateral View Radiolucency, 5 Years Zone 8 | 10 Participants |