Trial Outcomes & Findings for Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System (NCT NCT02154516)
NCT ID: NCT02154516
Last Updated: 2024-12-06
Results Overview
Device related revisions reported by the number of participants with a revision required (Yes/No).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Postoperatively through 10 years
Results posted on
2024-12-06
Participant Flow
Participant milestones
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
6
|
|
Overall Study
COMPLETED
|
16
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Removal/revision of device
|
1
|
0
|
|
Overall Study
Death
|
2
|
1
|
Baseline Characteristics
Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System
Baseline characteristics by cohort
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
n=20 Participants
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
n=6 Participants
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 12.48 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 13.25 • n=7 Participants
|
51.6 years
STANDARD_DEVIATION 12.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27 kg/m^2
STANDARD_DEVIATION 15.94 • n=5 Participants
|
86 kg/m^2
STANDARD_DEVIATION 16.38 • n=7 Participants
|
83.8 kg/m^2
STANDARD_DEVIATION 15.75 • n=5 Participants
|
|
Treated Hip Side
Left Only
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Treated Hip Side
Right Only
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Treated Hip Side
Both Left and Right (Bilateral)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Medical History - Primary Diagnosis
Osteoarthritis
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Medical History - Primary Diagnosis
Dysplasia/DDH
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Medical History - Primary Diagnosis
Avascular necrosis
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Medical History - Primary Diagnosis
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medical History - Primary Diagnosis
Missing
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperatively through 10 yearsPopulation: The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated.
Device related revisions reported by the number of participants with a revision required (Yes/No).
Outcome measures
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
n=20 Participants
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
n=6 Participants
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
|---|---|---|
|
Number of Participants With Device-Related Revisions
Revision Required: No
|
19 Participants
|
6 Participants
|
|
Number of Participants With Device-Related Revisions
Revision Required: Yes
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.Population: The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated.
For both investigational (i.e., Investigational Hard-on-Hard Total Hip Replacement Device) and control (i.e., Control Total Hip Replacement Device) participants, metal ion concentration in whole blood were measured for Cobalt (Co), Chromium (Cr), Nickel (Ni), Titanium (Ti), Zirconium (Zr), Niobium (Nb), Molybdenum (Mo), Vanadium (V) and Aluminum (Al) at each indicated time frame.
Outcome measures
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
n=20 Participants
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
n=6 Participants
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
|---|---|---|
|
Metal Ion Concentration in Whole Blood
Cobalt (Co) Concentration in Whole Blood - 3 Months
|
0.2 nanograms per milliliter (ng/ml)
Standard Deviation 0.14
|
0.3 nanograms per milliliter (ng/ml)
Standard Deviation 0.32
|
|
Metal Ion Concentration in Whole Blood
Cobalt (Co) Concentration in Whole Blood - 6 Months
|
0.2 nanograms per milliliter (ng/ml)
Standard Deviation 0.09
|
0.2 nanograms per milliliter (ng/ml)
Standard Deviation 0.08
|
|
Metal Ion Concentration in Whole Blood
Cobalt (Co) Concentration in Whole Blood - 1 Year
|
0.2 nanograms per milliliter (ng/ml)
Standard Deviation 0.10
|
0.2 nanograms per milliliter (ng/ml)
Standard Deviation 0.10
|
|
Metal Ion Concentration in Whole Blood
Cobalt (Co) Concentration in Whole Blood - 2 Years
|
0.3 nanograms per milliliter (ng/ml)
Standard Deviation 0.30
|
0.2 nanograms per milliliter (ng/ml)
Standard Deviation 0.12
|
|
Metal Ion Concentration in Whole Blood
Cobalt (Co) Concentration in Whole Blood - 5 Years
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.06
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.07
|
|
Metal Ion Concentration in Whole Blood
Cobalt (Co) Concentration in Whole Blood - 7 Years
|
0.3 nanograms per milliliter (ng/ml)
Standard Deviation 0.17
|
1.0 nanograms per milliliter (ng/ml)
Standard Deviation 1.56
|
|
Metal Ion Concentration in Whole Blood
Cobalt (Co) Concentration in Whole Blood -10 Years
|
0.3 nanograms per milliliter (ng/ml)
Standard Deviation 0.12
|
0.2 nanograms per milliliter (ng/ml)
Standard Deviation 0.06
|
|
Metal Ion Concentration in Whole Blood
Chromium (Cr) Concentration in Whole Blood - 3 Months
|
0.5 nanograms per milliliter (ng/ml)
Standard Deviation 0.18
|
0.5 nanograms per milliliter (ng/ml)
Standard Deviation 0.16
|
|
Metal Ion Concentration in Whole Blood
Chromium (Cr) Concentration in Whole Blood - 6 Months
|
0.4 nanograms per milliliter (ng/ml)
Standard Deviation 0.04
|
0.4 nanograms per milliliter (ng/ml)
Standard Deviation 0.01
|
|
Metal Ion Concentration in Whole Blood
Chromium (Cr) Concentration in Whole Blood - 1 Year
|
0.4 nanograms per milliliter (ng/ml)
Standard Deviation 0.09
|
0.4 nanograms per milliliter (ng/ml)
Standard Deviation 0.07
|
|
Metal Ion Concentration in Whole Blood
Chromium (Cr) Concentration in Whole Blood - 2 Years
|
0.7 nanograms per milliliter (ng/ml)
Standard Deviation 0.56
|
0.6 nanograms per milliliter (ng/ml)
Standard Deviation 0.25
|
|
Metal Ion Concentration in Whole Blood
Chromium (Cr) Concentration in Whole Blood - 5 Years
|
0.6 nanograms per milliliter (ng/ml)
Standard Deviation 0.10
|
0.6 nanograms per milliliter (ng/ml)
Standard Deviation 0.26
|
|
Metal Ion Concentration in Whole Blood
Chromium (Cr) Concentration in Whole Blood - 7 Years
|
0.6 nanograms per milliliter (ng/ml)
Standard Deviation 0.21
|
0.8 nanograms per milliliter (ng/ml)
Standard Deviation 0.51
|
|
Metal Ion Concentration in Whole Blood
Chromium (Cr) Concentration in Whole Blood - 10 Years
|
0.6 nanograms per milliliter (ng/ml)
Standard Deviation 0.51
|
0.7 nanograms per milliliter (ng/ml)
Standard Deviation 0.38
|
|
Metal Ion Concentration in Whole Blood
Nickel (Ni) Concentration in Whole Blood - 3 Months
|
1.2 nanograms per milliliter (ng/ml)
Standard Deviation 2.67
|
0.9 nanograms per milliliter (ng/ml)
Standard Deviation 0.59
|
|
Metal Ion Concentration in Whole Blood
Nickel (Ni) Concentration in Whole Blood - 6 Months
|
2.3 nanograms per milliliter (ng/ml)
Standard Deviation 6.99
|
0.5 nanograms per milliliter (ng/ml)
Standard Deviation 0.00
|
|
Metal Ion Concentration in Whole Blood
Nickel (Ni) Concentration in Whole Blood - 1 Year
|
0.6 nanograms per milliliter (ng/ml)
Standard Deviation 0.20
|
0.5 nanograms per milliliter (ng/ml)
Standard Deviation 0.05
|
|
Metal Ion Concentration in Whole Blood
Nickel (Ni) Concentration in Whole Blood - 2 Years
|
0.9 nanograms per milliliter (ng/ml)
Standard Deviation 0.55
|
0.6 nanograms per milliliter (ng/ml)
Standard Deviation 0.12
|
|
Metal Ion Concentration in Whole Blood
Nickel (Ni) Concentration in Whole Blood - 5 Years
|
0.6 nanograms per milliliter (ng/ml)
Standard Deviation 0.22
|
0.8 nanograms per milliliter (ng/ml)
Standard Deviation 0.57
|
|
Metal Ion Concentration in Whole Blood
Nickel (Ni) Concentration in Whole Blood - 7 Years
|
0.9 nanograms per milliliter (ng/ml)
Standard Deviation 0.29
|
0.9 nanograms per milliliter (ng/ml)
Standard Deviation 0.85
|
|
Metal Ion Concentration in Whole Blood
Nickel (Ni) Concentration in Whole Blood - 10 Years
|
0.7 nanograms per milliliter (ng/ml)
Standard Deviation 0.18
|
1.5 nanograms per milliliter (ng/ml)
Standard Deviation 1.16
|
|
Metal Ion Concentration in Whole Blood
Titanium (Ti) Concentration in Whole Blood - 3 Months
|
1.5 nanograms per milliliter (ng/ml)
Standard Deviation 0.62
|
1.4 nanograms per milliliter (ng/ml)
Standard Deviation 0.63
|
|
Metal Ion Concentration in Whole Blood
Titanium (Ti) Concentration in Whole Blood - 6 Months
|
1.5 nanograms per milliliter (ng/ml)
Standard Deviation 0.41
|
1.9 nanograms per milliliter (ng/ml)
Standard Deviation 0.91
|
|
Metal Ion Concentration in Whole Blood
Titanium (Ti) Concentration in Whole Blood - 1 Year
|
1.7 nanograms per milliliter (ng/ml)
Standard Deviation 0.35
|
2.3 nanograms per milliliter (ng/ml)
Standard Deviation 1.10
|
|
Metal Ion Concentration in Whole Blood
Titanium (Ti) Concentration in Whole Blood - 2 Years
|
1.5 nanograms per milliliter (ng/ml)
Standard Deviation 0.66
|
1.7 nanograms per milliliter (ng/ml)
Standard Deviation 0.28
|
|
Metal Ion Concentration in Whole Blood
Titanium (Ti) Concentration in Whole Blood - 5 Years
|
1.8 nanograms per milliliter (ng/ml)
Standard Deviation 1.12
|
1.8 nanograms per milliliter (ng/ml)
Standard Deviation 0.30
|
|
Metal Ion Concentration in Whole Blood
Titanium (Ti) Concentration in Whole Blood - 7 Years
|
1.7 nanograms per milliliter (ng/ml)
Standard Deviation 0.60
|
1.4 nanograms per milliliter (ng/ml)
Standard Deviation 0.75
|
|
Metal Ion Concentration in Whole Blood
Titanium (Ti) Concentration in Whole Blood - 10 Years
|
1.3 nanograms per milliliter (ng/ml)
Standard Deviation 0.52
|
2.3 nanograms per milliliter (ng/ml)
Standard Deviation 1.89
|
|
Metal Ion Concentration in Whole Blood
Zirconium (Zr) Concentration in Whole Blood - 3 Months
|
0.6 nanograms per milliliter (ng/ml)
Standard Deviation 0.30
|
0.2 nanograms per milliliter (ng/ml)
Standard Deviation 0.07
|
|
Metal Ion Concentration in Whole Blood
Zirconium (Zr) Concentration in Whole Blood - 6 Months
|
0.4 nanograms per milliliter (ng/ml)
Standard Deviation 0.11
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.03
|
|
Metal Ion Concentration in Whole Blood
Zirconium (Zr) Concentration in Whole Blood - 1 Year
|
0.3 nanograms per milliliter (ng/ml)
Standard Deviation 0.15
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.05
|
|
Metal Ion Concentration in Whole Blood
Zirconium (Zr) Concentration in Whole Blood - 2 Years
|
0.5 nanograms per milliliter (ng/ml)
Standard Deviation 0.27
|
0.3 nanograms per milliliter (ng/ml)
Standard Deviation 0.33
|
|
Metal Ion Concentration in Whole Blood
Zirconium (Zr) Concentration in Whole Blood - 5 Years
|
0.4 nanograms per milliliter (ng/ml)
Standard Deviation 0.30
|
0.2 nanograms per milliliter (ng/ml)
Standard Deviation 0.05
|
|
Metal Ion Concentration in Whole Blood
Zirconium (Zr) Concentration in Whole Blood - 7 Years
|
0.8 nanograms per milliliter (ng/ml)
Standard Deviation 0.64
|
0.3 nanograms per milliliter (ng/ml)
Standard Deviation 0.16
|
|
Metal Ion Concentration in Whole Blood
Zirconium (Zr) Concentration in Whole Blood - 10 Years
|
0.5 nanograms per milliliter (ng/ml)
Standard Deviation 0.49
|
0.2 nanograms per milliliter (ng/ml)
Standard Deviation 0.21
|
|
Metal Ion Concentration in Whole Blood
Niobium (Nb) Concentration in Whole Blood - 3 Months
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.02
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.01
|
|
Metal Ion Concentration in Whole Blood
Niobium (Nb) Concentration in Whole Blood - 6 Months
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.02
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.00
|
|
Metal Ion Concentration in Whole Blood
Niobium (Nb) Concentration in Whole Blood - 1 Year
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.00
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.00
|
|
Metal Ion Concentration in Whole Blood
Niobium (Nb) Concentration in Whole Blood - 2 Years
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.01
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.01
|
|
Metal Ion Concentration in Whole Blood
Niobium (Nb) Concentration in Whole Blood - 5 Years
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.00
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.02
|
|
Metal Ion Concentration in Whole Blood
Niobium (Nb) Concentration in Whole Blood - 7 Years
|
0.2 nanograms per milliliter (ng/ml)
Standard Deviation 0.28
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.03
|
|
Metal Ion Concentration in Whole Blood
Niobium (Nb) Concentration in Whole Blood - 10 Years
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.01
|
0.0 nanograms per milliliter (ng/ml)
Standard Deviation 0.01
|
|
Metal Ion Concentration in Whole Blood
Molybdenum (Mo) Concentration in Whole Blood - 3 Months
|
1.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.61
|
0.9 nanograms per milliliter (ng/ml)
Standard Deviation 0.51
|
|
Metal Ion Concentration in Whole Blood
Molybdenum (Mo) Concentration in Whole Blood - 6 Months
|
0.8 nanograms per milliliter (ng/ml)
Standard Deviation 0.52
|
0.7 nanograms per milliliter (ng/ml)
Standard Deviation 0.29
|
|
Metal Ion Concentration in Whole Blood
Molybdenum (Mo) Concentration in Whole Blood - 1 Year
|
0.5 nanograms per milliliter (ng/ml)
Standard Deviation 0.14
|
0.5 nanograms per milliliter (ng/ml)
Standard Deviation 0.25
|
|
Metal Ion Concentration in Whole Blood
Molybdenum (Mo) Concentration in Whole Blood - 2 Years
|
0.9 nanograms per milliliter (ng/ml)
Standard Deviation 0.44
|
0.6 nanograms per milliliter (ng/ml)
Standard Deviation 0.09
|
|
Metal Ion Concentration in Whole Blood
Molybdenum (Mo) Concentration in Whole Blood - 5 Years
|
0.7 nanograms per milliliter (ng/ml)
Standard Deviation 0.39
|
0.5 nanograms per milliliter (ng/ml)
Standard Deviation 0.14
|
|
Metal Ion Concentration in Whole Blood
Molybdenum (Mo) Concentration in Whole Blood - 7 Years
|
1.0 nanograms per milliliter (ng/ml)
Standard Deviation 0.96
|
0.6 nanograms per milliliter (ng/ml)
Standard Deviation 0.64
|
|
Metal Ion Concentration in Whole Blood
Molybdenum (Mo) Concentration in Whole Blood - 10 Years
|
0.6 nanograms per milliliter (ng/ml)
Standard Deviation 0.31
|
0.8 nanograms per milliliter (ng/ml)
Standard Deviation 0.55
|
|
Metal Ion Concentration in Whole Blood
Vanadium (V) Concentration in Whole Blood - 3 Months
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.17
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.00
|
|
Metal Ion Concentration in Whole Blood
Vanadium (V) Concentration in Whole Blood - 6 Months
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.05
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.00
|
|
Metal Ion Concentration in Whole Blood
Vanadium (V) Concentration in Whole Blood - 1 Year
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.06
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.00
|
|
Metal Ion Concentration in Whole Blood
Vanadium (V) Concentration in Whole Blood - 2 Years
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.04
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.01
|
|
Metal Ion Concentration in Whole Blood
Vanadium (V) Concentration in Whole Blood - 5 Years
|
0.3 nanograms per milliliter (ng/ml)
Standard Deviation 0.65
|
0.01 nanograms per milliliter (ng/ml)
Standard Deviation 0.03
|
|
Metal Ion Concentration in Whole Blood
Vanadium (V) Concentration in Whole Blood - 7 Years
|
0.2 nanograms per milliliter (ng/ml)
Standard Deviation 0.06
|
0.2 nanograms per milliliter (ng/ml)
Standard Deviation 0.09
|
|
Metal Ion Concentration in Whole Blood
Vanadium (V) Concentration in Whole Blood - 10 Years
|
0.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.14
|
0.3 nanograms per milliliter (ng/ml)
Standard Deviation 0.19
|
|
Metal Ion Concentration in Whole Blood
Aluminum (Al) Concentration in Whole Blood - 3 Months
|
5.8 nanograms per milliliter (ng/ml)
Standard Deviation 1.61
|
5.9 nanograms per milliliter (ng/ml)
Standard Deviation 1.96
|
|
Metal Ion Concentration in Whole Blood
Aluminum (Al) Concentration in Whole Blood - 6 Months
|
7.0 nanograms per milliliter (ng/ml)
Standard Deviation 3.80
|
6.1 nanograms per milliliter (ng/ml)
Standard Deviation 0.98
|
|
Metal Ion Concentration in Whole Blood
Aluminum (Al) Concentration in Whole Blood - 1 Year
|
8.5 nanograms per milliliter (ng/ml)
Standard Deviation 4.62
|
10.3 nanograms per milliliter (ng/ml)
Standard Deviation 5.01
|
|
Metal Ion Concentration in Whole Blood
Aluminum (Al) Concentration in Whole Blood - 2 Years
|
11.2 nanograms per milliliter (ng/ml)
Standard Deviation 6.86
|
7.2 nanograms per milliliter (ng/ml)
Standard Deviation 2.07
|
|
Metal Ion Concentration in Whole Blood
Aluminum (Al) Concentration in Whole Blood - 5 Years
|
10.4 nanograms per milliliter (ng/ml)
Standard Deviation 7.20
|
9.4 nanograms per milliliter (ng/ml)
Standard Deviation 9.93
|
|
Metal Ion Concentration in Whole Blood
Aluminum (Al) Concentration in Whole Blood - 7 Years
|
15.0 nanograms per milliliter (ng/ml)
Standard Deviation 10.50
|
10.0 nanograms per milliliter (ng/ml)
Standard Deviation 5.98
|
|
Metal Ion Concentration in Whole Blood
Aluminum (Al) Concentration in Whole Blood - 10 Years
|
11.0 nanograms per milliliter (ng/ml)
Standard Deviation 7.02
|
7.1 nanograms per milliliter (ng/ml)
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.Population: The Intent to Treat (ITT) population included participants enrolled in the study with data available at the time frame indicated. The ITT did not include those that only provided retrospective data, therefore only data for the Investigational Hard-on-Hard Total Hip Replacement Device group was collected.
The Harris Hip Score (HHS), which ranges from 0 (worst) to 100 (best), considers information on pain, function, and range of motion. HHS was measured for Investigational Hard-on-Hard Total Hip Replacement Device only.
Outcome measures
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
n=20 Participants
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
|---|---|---|
|
Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only
Preoperative
|
51.0 score on a scale
Standard Deviation 9.48
|
—
|
|
Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only
3 Months
|
85.6 score on a scale
Standard Deviation 11.28
|
—
|
|
Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only
6 Months
|
92.6 score on a scale
Standard Deviation 9.77
|
—
|
|
Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only
1 Year
|
94.7 score on a scale
Standard Deviation 9.79
|
—
|
|
Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only
2 Years
|
95.2 score on a scale
Standard Deviation 10.21
|
—
|
|
Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only
5 Years
|
92.9 score on a scale
Standard Deviation 14.44
|
—
|
|
Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only
7 Years
|
94.9 score on a scale
Standard Deviation 12.60
|
—
|
|
Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only
10 Years
|
97.1 score on a scale
Standard Deviation 9.35
|
—
|
SECONDARY outcome
Timeframe: Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, 10 yearsPopulation: The Intent to Treat (ITT) population included participants enrolled in the study with data available at the time frame indicated. The ITT did not include those that only provided retrospective data, therefore only data for the Investigational Hard-on-Hard Total Hip Replacement Device group was collected.
The Hip Disability and Osteoarthritis Outcome Scores (HOOS) was measured for Investigational Hard-on-Hard Total Hip Replacement Device only and included 40 items with five responses from five subcategories of Pain, Symptoms and Stiffness, Activities of Daily Living, Function in Sports and Recreational Activities, and Quality of Life to produce a total HOOS. The total HOOS scale ranged from 0 to 100, with 0 indicating the worst possible score and 100 indicating the best possible score.
Outcome measures
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
n=20 Participants
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
|---|---|---|
|
Hip Disability and Osteoarthritis Outcome Scores (HOOS)
Preoperative
|
44.9 score on a scale
Standard Deviation 19.86
|
—
|
|
Hip Disability and Osteoarthritis Outcome Scores (HOOS)
3 Months
|
83.8 score on a scale
Standard Deviation 18.84
|
—
|
|
Hip Disability and Osteoarthritis Outcome Scores (HOOS)
6 Months
|
85.8 score on a scale
Standard Deviation 21.08
|
—
|
|
Hip Disability and Osteoarthritis Outcome Scores (HOOS)
1 Year
|
91.8 score on a scale
Standard Deviation 14.53
|
—
|
|
Hip Disability and Osteoarthritis Outcome Scores (HOOS)
2 Years
|
92.9 score on a scale
Standard Deviation 14.07
|
—
|
|
Hip Disability and Osteoarthritis Outcome Scores (HOOS)
5 Years
|
85.6 score on a scale
Standard Deviation 26.91
|
—
|
|
Hip Disability and Osteoarthritis Outcome Scores (HOOS)
7 Years
|
88.8 score on a scale
Standard Deviation 22.95
|
—
|
|
Hip Disability and Osteoarthritis Outcome Scores (HOOS)
10 Years
|
88.4 score on a scale
Standard Deviation 22.87
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operativePopulation: The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. Data was not collected for the control total hip replacement device group at 3 months, 6 months, 1 year, and 2 years.
Radiolucencies determined by number of participants with occurrence of radiolucent lines and osteolysis (Yes/No)
Outcome measures
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
n=20 Participants
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
n=5 Participants
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
|---|---|---|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 3 months · No
|
17 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 3 months · Yes
|
3 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 3 months · No
|
17 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 3 months · Yes
|
3 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 6 months · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 6 months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 6 months · No
|
18 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 6 months · Yes
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 1 Year · No
|
15 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 1 Year · Yes
|
4 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 1 Year · No
|
13 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 1 Year · Yes
|
6 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 2 Years · No
|
17 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 2 Years · Yes
|
2 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 2 Years · No
|
17 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 2 Years · Yes
|
2 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 5 Years · No
|
18 Participants
|
5 Participants
|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 5 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 5 Years · No
|
18 Participants
|
5 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 5 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 7 Years · No
|
16 Participants
|
4 Participants
|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 7 Years · Yes
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 7 Years · No
|
16 Participants
|
4 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 7 Years · Yes
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 10 Years · No
|
14 Participants
|
4 Participants
|
|
Radiographic Measures: Radiolucencies
Radiolucent Line - 10 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 10 Years · No
|
14 Participants
|
4 Participants
|
|
Radiographic Measures: Radiolucencies
Osteolysis - 10 Years · Yes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operativePopulation: The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. Data was not collected for the control total hip replacement device group at 3 months, 6 months, 1 year, and 2 years.
Occurrence of Heterotopic Ossification in participants (Yes/No)
Outcome measures
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
n=20 Participants
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
n=5 Participants
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
|---|---|---|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 5 Years · Heterotopic Ossification Grade 3
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 3 Months · No Heterotopic Ossification
|
18 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 3 Months · Heterotopic Ossification Grade 1
|
2 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 3 Months · Heterotopic Ossification Grade 2
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 3 Months · Heterotopic Ossification Grade 3
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 3 Months · Heterotopic Ossification Grade 4
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 6 Months · No Heterotopic Ossification
|
15 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 6 Months · Heterotopic Ossification Grade 1
|
3 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 6 Months · Heterotopic Ossification Grade 2
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 6 Months · Heterotopic Ossification Grade 3
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 6 Months · Heterotopic Ossification Grade 4
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 1 Year · No Heterotopic Ossification
|
14 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 1 Year · Heterotopic Ossification Grade 1
|
4 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 1 Year · Heterotopic Ossification Grade 2
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 1 Year · Heterotopic Ossification Grade 3
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 1 Year · Heterotopic Ossification Grade 4
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 2 Years · No Heterotopic Ossification
|
18 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 2 Years · Heterotopic Ossification Grade 1
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 2 Years · Heterotopic Ossification Grade 2
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 2 Years · Heterotopic Ossification Grade 3
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 2 Years · Heterotopic Ossification Grade 4
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 5 Years · No Heterotopic Ossification
|
16 Participants
|
4 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 5 Years · Heterotopic Ossification Grade 1
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 5 Years · Heterotopic Ossification Grade 2
|
1 Participants
|
1 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 5 Years · Heterotopic Ossification Grade 4
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 7 Years · No Heterotopic Ossification
|
14 Participants
|
2 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 7 Years · Heterotopic Ossification Grade 1
|
2 Participants
|
2 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 7 Years · Heterotopic Ossification Grade 2
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 7 Years · Heterotopic Ossification Grade 3
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 7 Years · Heterotopic Ossification Grade 4
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 10 Years · No Heterotopic Ossification
|
13 Participants
|
2 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 10 Years · Heterotopic Ossification Grade 1
|
0 Participants
|
2 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 10 Years · Heterotopic Ossification Grade 2
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 10 Years · Heterotopic Ossification Grade 3
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Heterotopic Ossification
Heterotopic Ossification - 10 Years · Heterotopic Ossification Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operativePopulation: The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. Data was not collected for the control total hip replacement device group at 3 months, 6 months, 1 year, and 2 years.
Occurrence of Subsidence in Investigational Hard-on-Hard Total Hip Replacement Device participants (Yes/No) categorized by: * Acetabular Cup Subsidence * Stem Subsidence * Evidence of cortical thickening * Acetabular component fail * Femoral component fail * Other
Outcome measures
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
n=20 Participants
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
n=5 Participants
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
|---|---|---|
|
Radiographic Measures: Subsidence
Other - 10 Years · No
|
14 Participants
|
4 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 7 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 7 Years · No
|
17 Participants
|
4 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 7 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Other - 7 Years · No
|
17 Participants
|
4 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 10 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence - 10 Years · No
|
14 Participants
|
4 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence - 10 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 10 Years · No
|
13 Participants
|
4 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 10 Years · Yes
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Other - 7 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 10 Years · No
|
14 Participants
|
4 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 3 months · No
|
20 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 3 months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence - 3 months · No
|
20 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence - 3 months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 3 Months · No
|
20 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 3 Months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 3 Months · No
|
20 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 3 Months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 3 Months · No
|
20 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 3 Months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Other - 3 Months · No
|
20 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Other - 3 Months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 6 months · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 6 months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence - 6 Months · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence - 6 Months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 6 Months · No
|
18 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 6 Months · Yes
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 6 Months · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 6 Months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 6 Months · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 6 Months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Other- 6 Months · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Other- 6 Months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 1 Year · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 1 Year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence - 1 Year · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence - 1 Year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 1 Year · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 1 Year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 1 Year · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 1 Year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 1 Year · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 1 Year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Other - 1 Year · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Other - 1 Year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 2 Years · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 2 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence 2 Years · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence 2 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 2 Years · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 2 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 2 Years · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 2 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 2 Years · No
|
19 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 2 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Other - 2 Years · No
|
18 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Other - 2 Years · Yes
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 5 Years · No
|
18 Participants
|
5 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 5 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence - 5 Years · No
|
17 Participants
|
5 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence - 5 Years · Yes
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 5 Years · No
|
18 Participants
|
4 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 5 Years · Yes
|
0 Participants
|
1 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 5 Years · No
|
18 Participants
|
5 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 5 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 5 Years · No
|
18 Participants
|
5 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 5 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Other - 5 Years · No
|
17 Participants
|
5 Participants
|
|
Radiographic Measures: Subsidence
Other - 5 Years · Yes
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 7 Years · No
|
17 Participants
|
4 Participants
|
|
Radiographic Measures: Subsidence
Acetabular Cup Subsidence - 7 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence - 7 Years · No
|
17 Participants
|
4 Participants
|
|
Radiographic Measures: Subsidence
Stem Subsidence - 7 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 7 Years · No
|
16 Participants
|
4 Participants
|
|
Radiographic Measures: Subsidence
Evidence of cortical thickening - 7 Years · Yes
|
1 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 7 Years · No
|
17 Participants
|
4 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 10 Years · No
|
14 Participants
|
4 Participants
|
|
Radiographic Measures: Subsidence
Acetabular component fail - 10 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 10 Years · No
|
14 Participants
|
4 Participants
|
|
Radiographic Measures: Subsidence
Femoral component fail - 10 Years · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Measures: Subsidence
Other - 10 Years · Yes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Intra-operative, up to 50 minutesPopulation: The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated.
Blood loss during surgery measured in milliliters (ml) of blood
Outcome measures
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
n=20 Participants
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
n=6 Participants
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
|---|---|---|
|
Health Economic Outcomes: Surgical Blood Loss
|
324 milliliters (mL)
Standard Deviation 218.6
|
365 milliliters (mL)
Standard Deviation 164.2
|
SECONDARY outcome
Timeframe: Hospital admission to dischargePopulation: Length of hospital stay data was not collected as part of the 10 year extension study.
Length of stay measured by number of days spent in hospital
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Intra-operativePopulation: The Intent to Treat (ITT) population included participants enrolled in the study with data available at the time frame indicated. The ITT did not include those that only provided retrospective data, therefore only data for the Investigational Hard-on-Hard Total Hip Replacement Device group was collected.
Operative time in minutes from first incision into skin to time when last suture is applied for the Investigational Hard-on-Hard Total Hip Replacement Device group only
Outcome measures
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
n=20 Participants
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
|---|---|---|
|
Health Economic Outcomes: Operative Time
|
50.0 Minutes
Standard Deviation 14.9
|
—
|
SECONDARY outcome
Timeframe: Up to 10 yearsPopulation: Re-hospitalizations data was not collected as part of the 10 year extension study.
Re-hospitalizations measured by the number of re-admissions to hospital
Outcome measures
Outcome data not reported
Adverse Events
Investigational Hard-on-Hard Total Hip Replacement Device
Serious events: 9 serious events
Other events: 20 other events
Deaths: 2 deaths
Control Total Hip Replacement Device
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
n=20 participants at risk
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
n=6 participants at risk
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
|---|---|---|
|
Renal and urinary disorders
Kidney Stones
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Cardiac disorders
Uncontrolled Hypertension
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
General disorders
Death from unknown cause
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Contralateral hip replacement
|
15.0%
3/20 • Number of events 3 • Surgery to 10-years
|
16.7%
1/6 • Number of events 1 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
left shoulder Rotator cuff tear
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Psychiatric disorders
Depression and psychosomatic disorder
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Gastrointestinal disorders
Gastroscopy and biopsy
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Worsening of prior muscle spasm and pain in study hip
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
General disorders
Death
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Bilateral inguinal hernia
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Anterior right hip dislocation
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis left ankle
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis effusion left knee
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Right shoulder rotator cuff tear
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Loosening of implant stem
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Fall onto right hip (replacement hip)
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Surgical and medical procedures
Breast augmentation surgery
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Surgical and medical procedures
Surgery left foot
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Sacroilliac joint pain
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Surgical and medical procedures
Sacroilliac joint pain treatment
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Vascular disorders
Haemorrhoids resulting in surgery
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Cardiac disorders
Death
|
0.00%
0/20 • Surgery to 10-years
|
16.7%
1/6 • Number of events 1 • Surgery to 10-years
|
|
Reproductive system and breast disorders
Hysterectomy
|
0.00%
0/20 • Surgery to 10-years
|
16.7%
1/6 • Number of events 1 • Surgery to 10-years
|
Other adverse events
| Measure |
Investigational Hard-on-Hard Total Hip Replacement Device
n=20 participants at risk
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
* R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
* Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
|
Control Total Hip Replacement Device
n=6 participants at risk
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
* R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
* OXINIUM heads on polyethylene liners or
* Ceramic heads on ceramic liners (all uncemented components)
|
|---|---|---|
|
Blood and lymphatic system disorders
Increased Vanadium Levels
|
20.0%
4/20 • Number of events 4 • Surgery to 10-years
|
33.3%
2/6 • Number of events 2 • Surgery to 10-years
|
|
Blood and lymphatic system disorders
Increased Nickel Levels
|
60.0%
12/20 • Number of events 12 • Surgery to 10-years
|
66.7%
4/6 • Number of events 4 • Surgery to 10-years
|
|
Blood and lymphatic system disorders
Increased Titanium Levels
|
10.0%
2/20 • Number of events 2 • Surgery to 10-years
|
16.7%
1/6 • Number of events 1 • Surgery to 10-years
|
|
Blood and lymphatic system disorders
Increased Cobalt Levels
|
55.0%
11/20 • Number of events 11 • Surgery to 10-years
|
33.3%
2/6 • Number of events 2 • Surgery to 10-years
|
|
Blood and lymphatic system disorders
Increased Chromium Levels
|
10.0%
2/20 • Number of events 2 • Surgery to 10-years
|
16.7%
1/6 • Number of events 1 • Surgery to 10-years
|
|
Blood and lymphatic system disorders
Increased Niobium Levels
|
15.0%
3/20 • Number of events 3 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Skin and subcutaneous tissue disorders
Rash at operative site
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Greater trochanter bursitis R hip
|
10.0%
2/20 • Number of events 2 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Cardiac disorders
Hypertension
|
25.0%
5/20 • Number of events 5 • Surgery to 10-years
|
16.7%
1/6 • Number of events 1 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Intermittent back pain
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis left hip
|
10.0%
2/20 • Number of events 2 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Pain and noise in right hip
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Reproductive system and breast disorders
Benign prostate hyperplasia
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 2 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Cardiac disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Skin and subcutaneous tissue disorders
Rash on back
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
16.7%
1/6 • Number of events 1 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Gout
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Hip noise
|
20.0%
4/20 • Number of events 4 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Fall
|
5.0%
1/20 • Number of events 3 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain and shortness of breath
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Right knee pain
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Nervous system disorders
Femoral nerve impingement right leg
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Respiratory, thoracic and mediastinal disorders
Low oxygen levels
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Sacroilliac pain
|
5.0%
1/20 • Number of events 3 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Left tennis elbow
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Surgery-left foot
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Endocrine disorders
Diabetes - new
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Renal and urinary disorders
Polyuria and hematuria
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Gastrointestinal disorders
Vomitting
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Renal and urinary disorders
Kidney stones
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Pain in operative hip
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
16.7%
1/6 • Number of events 1 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
5.0%
1/20 • Number of events 2 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Skin and subcutaneous tissue disorders
Rash - jugular
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Nervous system disorders
Peripheral neuropathy
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Renal and urinary disorders
Urinary Tract Infection
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Infections and infestations
Surgical site reaction
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Nervous system disorders
Perineal nerve weakness left foot
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Skin and subcutaneous tissue disorders
rash - left foot
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Swelling below left fibular head
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Renal and urinary disorders
Urine retention after catheter removal
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Gastrointestinal disorders
Gastroscopy
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Psychiatric disorders
Severe depression
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Renal and urinary disorders
Urine retention - unknown cause
|
5.0%
1/20 • Number of events 1 • Surgery to 10-years
|
0.00%
0/6 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Trochanter bursitis left hip
|
0.00%
0/20 • Surgery to 10-years
|
16.7%
1/6 • Number of events 1 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Fall on operative hip
|
0.00%
0/20 • Surgery to 10-years
|
16.7%
1/6 • Number of events 1 • Surgery to 10-years
|
|
Skin and subcutaneous tissue disorders
Rash on upper right arm
|
0.00%
0/20 • Surgery to 10-years
|
16.7%
1/6 • Number of events 1 • Surgery to 10-years
|
|
Musculoskeletal and connective tissue disorders
Fall on contralateral hip
|
0.00%
0/20 • Surgery to 10-years
|
16.7%
1/6 • Number of events 1 • Surgery to 10-years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60