Trial Outcomes & Findings for Arcos Revision Stem: Evaluation of Clinical Performance (NCT NCT01820611)
NCT ID: NCT01820611
Last Updated: 2025-01-20
Results Overview
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
COMPLETED
74 participants
5 year post surgery
2025-01-20
Participant Flow
In total, 74 cases who received the Arcos hip stem were evaluated at 5 study centers in Europe.
After checking the operative records for the prospective and retrospectively enrolled cases, only 74 cases were eligible to be included in the study.
Participant milestones
| Measure |
With Bonemaster HA
100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite
Arcos Revision Stem System: Revision Hip System
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
With Bonemaster HA
100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite
Arcos Revision Stem System: Revision Hip System
|
|---|---|
|
Overall Study
Death
|
8
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
With Bonemaster HA
n=74 Participants
Patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite
Arcos Revision Stem System: Revision Hip System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=74 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=74 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=74 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=74 Participants
|
|
Region of Enrollment
Sweden
|
19 participants
n=74 Participants
|
|
Region of Enrollment
Finland
|
15 participants
n=74 Participants
|
|
Region of Enrollment
United Kingdom
|
22 participants
n=74 Participants
|
|
Region of Enrollment
Spain
|
18 participants
n=74 Participants
|
|
BMI
|
29.2 kg/m2
STANDARD_DEVIATION 6.4 • n=74 Participants
|
PRIMARY outcome
Timeframe: 5 year post surgeryPopulation: All study patients
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
Outcome measures
| Measure |
With Bonemaster HA
n=74 Participants
100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite
Arcos Revision Stem System: Revision Hip System
|
|---|---|
|
Survivorship
|
74 Participants
|
SECONDARY outcome
Timeframe: 6 weeks, 1 year, 3 years and 5 years Post SurgeryPopulation: 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.
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.
Outcome measures
| Measure |
With Bonemaster HA
n=74 Participants
100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite
Arcos Revision Stem System: Revision Hip System
|
|---|---|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 5 Years Zone 8
|
10 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 3 Years Zone 3
|
3 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 3 Years Zone 5
|
6 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 3 Years Zone 6
|
7 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 3 Years Zone 7
|
13 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 5 Years Zone 1
|
9 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 5 Years Zone 2
|
4 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 5 Years Zone 3
|
3 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 5 Years Zone 5
|
0.0 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 5 Years Zone 6
|
2 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 5 Years Zone 7
|
7 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 6 Weeks Zone 8
|
12 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 6 Weeks Zone 9
|
9 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 6 Weeks Zone 10
|
3 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 6 Weeks Zone 12
|
3 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 6 Weeks Zone 13
|
7 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 6 Weeks Zone 14
|
6 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 1 Year Zone 8
|
19 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 1 Year Zone 9
|
9 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 1 Year Zone 10
|
4 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 1 Year Zone 11
|
1 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 1 Year Zone 12
|
3 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 1 Year Zone 13
|
10 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 1 Year Zone 14
|
9 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 3 Years Zone 8
|
12 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 3 Years Zone 9
|
7 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 3 Years Zone 10
|
5 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 3 Years Zone 12
|
4 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 3 Years Zone 13
|
7 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 3 Years Zone 14
|
8 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 5 Years Zone 9
|
3 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 5 Years Zone 10
|
1 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 5 Years Zone 12
|
2 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 5 Years Zone 13
|
3 Participants
|
|
Radiographic Evaluation
Femoral Lateral View Radiolucency, 5 Years Zone 14
|
4 Participants
|
|
Radiographic Evaluation
Number of patients with Acetabular Radiolucency seen in their Xray images, 6 Weeks Zone 1
|
9 Participants
|
|
Radiographic Evaluation
Acetabular Radiolucency, 6 Weeks Zone 2
|
4 Participants
|
|
Radiographic Evaluation
Acetabular Radiolucency, 6 Weeks Zone 3
|
1 Participants
|
|
Radiographic Evaluation
Acetabular Radiolucency, 1 Year Zone 1
|
12 Participants
|
|
Radiographic Evaluation
Acetabular Radiolucency, 1 Year Zone 2
|
5 Participants
|
|
Radiographic Evaluation
Acetabular Radiolucency, 1 Year Zone 3
|
8 Participants
|
|
Radiographic Evaluation
Acetabular Radiolucency, 3 Year Zone 1
|
13 Participants
|
|
Radiographic Evaluation
Acetabular Radiolucency, 3 Year Zone 2
|
4 Participants
|
|
Radiographic Evaluation
Acetabular Radiolucency, 3 Year Zone 3
|
7 Participants
|
|
Radiographic Evaluation
Acetabular Radiolucency, 5 Year Zone 1
|
10 Participants
|
|
Radiographic Evaluation
Acetabular Radiolucency, 5 Year Zone 2
|
4 Participants
|
|
Radiographic Evaluation
Acetabular Radiolucency, 5 Year Zone 3
|
7 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 6 Weeks Zone 1
|
6 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 6 Weeks Zone 2
|
10 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 6 Weeks Zone 3
|
4 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 6 Weeks Zone 5
|
4 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 6 Weeks Zone 6
|
7 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 6 Weeks Zone 7
|
9 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 1 Year Zone 1
|
14 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 1 Year Zone 2
|
9 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 1 Year Zone 3
|
6 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 1 Year Zone 4
|
1 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 1 Year Zone 5
|
2 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 1 Year Zone 6
|
7 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 1 Year Zone 7
|
11 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 3 Years Zone 1
|
16 Participants
|
|
Radiographic Evaluation
Femoral AP View Radiolucency, 3 Years Zone 2
|
5 Participants
|
SECONDARY outcome
Timeframe: Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgeryPopulation: All study patients.
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.
Outcome measures
| Measure |
With Bonemaster HA
n=74 Participants
100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite
Arcos Revision Stem System: Revision Hip System
|
|---|---|
|
EQ5D
Preop EQ-5D
|
0.3 score on a scale
Standard Deviation 0.4
|
|
EQ5D
6 Weeks EQ-5D
|
0.6 score on a scale
Standard Deviation 0.2
|
|
EQ5D
1 Year EQ-5D
|
0.7 score on a scale
Standard Deviation 0.3
|
|
EQ5D
3 Years EQ-5D
|
0.7 score on a scale
Standard Deviation 0.3
|
|
EQ5D
5 Years EQ-5D
|
0.8 score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Preop, 6 weeks, 1 year, 3 years and 5 years post surgeryPopulation: All study patients
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.
Outcome measures
| Measure |
With Bonemaster HA
n=74 Participants
100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite
Arcos Revision Stem System: Revision Hip System
|
|---|---|
|
Oxford Hip Score
3 Years Oxford Hip Score
|
36.9 score on a scale
Standard Deviation 10.5
|
|
Oxford Hip Score
Preop Oxford Hip Score
|
18.8 score on a scale
Standard Deviation 8.6
|
|
Oxford Hip Score
6 Weeks Oxford Hip Score
|
28.3 score on a scale
Standard Deviation 8.8
|
|
Oxford Hip Score
1 Year Oxford Hip Score
|
34.4 score on a scale
Standard Deviation 10.9
|
|
Oxford Hip Score
5 Years Oxford Hip Score
|
39.3 score on a scale
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Preop, 6 Weeks, 1 Year, 3 Years and 5 Years post surgeryPopulation: All study patients
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.
Outcome measures
| Measure |
With Bonemaster HA
n=74 Participants
100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite
Arcos Revision Stem System: Revision Hip System
|
|---|---|
|
Harris Hip Score
Preop Harris Hip Score
|
41.3 score on a scale
Standard Deviation 15.6
|
|
Harris Hip Score
6 Weeks Harris Hip Score
|
60.0 score on a scale
Standard Deviation 15.3
|
|
Harris Hip Score
1 Year Harris Hip Score
|
73.0 score on a scale
Standard Deviation 21.3
|
|
Harris Hip Score
3 Years Harris Hip Score
|
78.3 score on a scale
Standard Deviation 19.1
|
|
Harris Hip Score
5 Years Harris Hip Score
|
79.8 score on a scale
Standard Deviation 16.8
|
Adverse Events
With Bonemaster HA
Serious adverse events
| Measure |
With Bonemaster HA
n=74 participants at risk
100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite
Arcos Revision Stem System: Revision Hip System
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Deep Infection
|
4.1%
3/74 • Number of events 4 • Operative, 6 Weeks, 1 Year, 3 Years and 5 Years
|
|
Musculoskeletal and connective tissue disorders
Dislocation and Sublaxation
|
4.1%
3/74 • Number of events 5 • Operative, 6 Weeks, 1 Year, 3 Years and 5 Years
|
|
Musculoskeletal and connective tissue disorders
Femoral Pain
|
2.7%
2/74 • Number of events 2 • Operative, 6 Weeks, 1 Year, 3 Years and 5 Years
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
4.1%
3/74 • Number of events 3 • Operative, 6 Weeks, 1 Year, 3 Years and 5 Years
|
|
Musculoskeletal and connective tissue disorders
Hematoma
|
1.4%
1/74 • Number of events 1 • Operative, 6 Weeks, 1 Year, 3 Years and 5 Years
|
|
Musculoskeletal and connective tissue disorders
Instability
|
1.4%
1/74 • Number of events 1 • Operative, 6 Weeks, 1 Year, 3 Years and 5 Years
|
|
Musculoskeletal and connective tissue disorders
Nerve and vascular deficit
|
2.7%
2/74 • Number of events 2 • Operative, 6 Weeks, 1 Year, 3 Years and 5 Years
|
|
Musculoskeletal and connective tissue disorders
Superficial Infection
|
1.4%
1/74 • Number of events 1 • Operative, 6 Weeks, 1 Year, 3 Years and 5 Years
|
|
Musculoskeletal and connective tissue disorders
Wound Drainage and Dehiscence
|
6.8%
5/74 • Number of events 5 • Operative, 6 Weeks, 1 Year, 3 Years and 5 Years
|
|
Musculoskeletal and connective tissue disorders
Other Hip Related Adverse Events
|
16.2%
12/74 • Number of events 20 • Operative, 6 Weeks, 1 Year, 3 Years and 5 Years
|
Other adverse events
| Measure |
With Bonemaster HA
n=74 participants at risk
100 patients using Arcos Revision Stem System with BoneMaster Hydroxyapatite
Arcos Revision Stem System: Revision Hip System
|
|---|---|
|
Infections and infestations
General Complications
|
12.2%
9/74 • Number of events 9 • Operative, 6 Weeks, 1 Year, 3 Years and 5 Years
|
|
Nervous system disorders
General Complications
|
5.4%
4/74 • Number of events 4 • Operative, 6 Weeks, 1 Year, 3 Years and 5 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place