Trial Outcomes & Findings for The Metaphyseal Hip Prosthesis - Total Hip (NCT NCT01501955)
NCT ID: NCT01501955
Last Updated: 2024-12-18
Results Overview
Stem movement measured with RSA (radiostereometric analysis) along the x-axis in mm. RSA is a technique to accurately measure 3D movement of the prosthesis in the bone. The movement is measured with respect to the situation directly postoperative.
COMPLETED
NA
20 participants
3 months, 6 months, 1 year and 2 years postoperatively
2024-12-18
Participant Flow
Participants were recruited from all patients eligible for a total hip replacement from either of the investigators at the Bravis Hospital in Roosendaal, between October 2012 and October 2013.
Pre-operatively a DEXA scan was made to confirm eligibility.
Participant milestones
| Measure |
Stanmore
Cemented Stanmore hip stem
|
MHP Hip Stem
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
Surgery
|
11
|
9
|
|
Overall Study
6 Weeks Postop
|
10
|
9
|
|
Overall Study
1 Year Postop
|
9
|
7
|
|
Overall Study
2 Years Postop
|
9
|
6
|
|
Overall Study
COMPLETED
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Stanmore
Cemented Stanmore hip stem
|
MHP Hip Stem
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Stanmore
n=11 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=9 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=11 Participants
|
6 Participants
n=9 Participants
|
15 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=11 Participants
|
5 Participants
n=9 Participants
|
11 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=11 Participants
|
4 Participants
n=9 Participants
|
9 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Netherlands
|
11 participants
n=11 Participants
|
9 participants
n=9 Participants
|
20 participants
n=20 Participants
|
|
Operative Side
Left
|
4 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
7 Participants
n=20 Participants
|
|
Operative Side
Right
|
7 Participants
n=11 Participants
|
6 Participants
n=9 Participants
|
13 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 3 months, 6 months, 1 year and 2 years postoperativelyPopulation: The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.
Stem movement measured with RSA (radiostereometric analysis) along the x-axis in mm. RSA is a technique to accurately measure 3D movement of the prosthesis in the bone. The movement is measured with respect to the situation directly postoperative.
Outcome measures
| Measure |
Stanmore
n=10 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=7 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
RSA Translation X
3 m postoperatively
|
0.05 mm
Standard Deviation 0.20
|
0.05 mm
Standard Deviation 0.26
|
|
RSA Translation X
6 m postoperatively
|
0.10 mm
Standard Deviation 0.29
|
0.08 mm
Standard Deviation 0.35
|
|
RSA Translation X
1 y postoperatively
|
0.13 mm
Standard Deviation 0.30
|
0.08 mm
Standard Deviation 0.41
|
|
RSA Translation X
2 y postoperatively
|
0.14 mm
Standard Deviation 0.42
|
0.21 mm
Standard Deviation 0.60
|
PRIMARY outcome
Timeframe: 3 months, 6 months, 1 year and 2 years postoperativelyPopulation: The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.
Stem movement along the y-axis in mm. (measured with RSA)
Outcome measures
| Measure |
Stanmore
n=10 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=7 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
RSA Translation Y
3 m postoperatively
|
-0.25 mm
Standard Deviation 0.34
|
-0.18 mm
Standard Deviation 0.22
|
|
RSA Translation Y
6 m postoperatively
|
-0.47 mm
Standard Deviation 0.50
|
-0.31 mm
Standard Deviation 0.28
|
|
RSA Translation Y
1 y postoperatively
|
-0.54 mm
Standard Deviation 0.67
|
-0.25 mm
Standard Deviation 0.24
|
|
RSA Translation Y
2 y postoperatively
|
-0.25 mm
Standard Deviation 0.22
|
-0.29 mm
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: 3 months, 6 months, 1 year and 2 years postoperativelyPopulation: The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.
Stem movement along z-axis in mm (measured with RSA)
Outcome measures
| Measure |
Stanmore
n=10 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=7 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
RSA Translation Z
3 m postoperatively
|
-0.10 mm
Standard Deviation 0.36
|
-0.08 mm
Standard Deviation 0.24
|
|
RSA Translation Z
6 m postoperatively
|
-0.23 mm
Standard Deviation 0.45
|
-0.02 mm
Standard Deviation 0.19
|
|
RSA Translation Z
1 y postoperatively
|
-0.19 mm
Standard Deviation 0.23
|
-0.19 mm
Standard Deviation 0.30
|
|
RSA Translation Z
2 y postoperatively
|
-0.25 mm
Standard Deviation 0.22
|
-0.29 mm
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: 3 months, 6 months, 1 year and 2 years postoperativelyPopulation: The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.
Stem Rotation around X-axis in degrees (measured with RSA)
Outcome measures
| Measure |
Stanmore
n=10 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=7 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
RSA Rotation X
3 m postoperatively
|
-0.22 mm
Standard Deviation 0.68
|
-0.18 mm
Standard Deviation 0.13
|
|
RSA Rotation X
6 m postoperatively
|
-0.18 mm
Standard Deviation 0.74
|
-0.23 mm
Standard Deviation 1.16
|
|
RSA Rotation X
1 y postoperatively
|
-0.27 mm
Standard Deviation 0.48
|
-0.44 mm
Standard Deviation 0.37
|
|
RSA Rotation X
2 y postoperatively
|
-0.42 mm
Standard Deviation 0.92
|
-1.18 mm
Standard Deviation 0.36
|
PRIMARY outcome
Timeframe: 3 months, 6 months, 1 year and 2 years postoperativelyPopulation: The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.
Stem rotation around the y-axis in degrees ( measured with RSA)
Outcome measures
| Measure |
Stanmore
n=10 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=7 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
RSA Rotation Y
3 m postoperatively
|
0.57 mm
Standard Deviation 0.86
|
0.65 mm
Standard Deviation 0.59
|
|
RSA Rotation Y
6 m postoperatively
|
1.13 mm
Standard Deviation 1.36
|
1.22 mm
Standard Deviation 1.44
|
|
RSA Rotation Y
1 y postoperatively
|
1.43 mm
Standard Deviation 1.29
|
0.52 mm
Standard Deviation 0.23
|
|
RSA Rotation Y
2 y postoperatively
|
1.86 mm
Standard Deviation 2.00
|
1.50 mm
Standard Deviation 0.48
|
PRIMARY outcome
Timeframe: 3 months, 6 months, 1 year and 2 years postoperativelyPopulation: The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.
Stem rotation around the z-axis in degrees (measured with RSA)
Outcome measures
| Measure |
Stanmore
n=10 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=7 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
RSA Rotation Z
3 m postoperatively
|
-0.05 mm
Standard Deviation 0.28
|
-0.26 mm
Standard Deviation 0.46
|
|
RSA Rotation Z
6 m postoperatively
|
-0.01 mm
Standard Deviation 0.37
|
-0.35 mm
Standard Deviation 1.63
|
|
RSA Rotation Z
1 y postoperatively
|
-0.11 mm
Standard Deviation 0.41
|
-0.71 mm
Standard Deviation 0.92
|
|
RSA Rotation Z
2 y postoperatively
|
-0.08 mm
Standard Deviation 0.57
|
-1.56 mm
Standard Deviation 1.55
|
PRIMARY outcome
Timeframe: 3 months, 6 months, 1 year and 2 years postoperativelyPopulation: The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.
Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem.
Outcome measures
| Measure |
Stanmore
n=10 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=7 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
RSA MTMP
6 m postoperatively
|
1.75 mm
Standard Deviation 1.30
|
1.34 mm
Standard Deviation 0.23
|
|
RSA MTMP
3 m postoperatively
|
1.44 mm
Standard Deviation 0.79
|
0.81 mm
Standard Deviation 0.29
|
|
RSA MTMP
1 y postoperatively
|
1.76 mm
Standard Deviation 1.13
|
1.31 mm
Standard Deviation 1.22
|
|
RSA MTMP
2 y postoperatively
|
2.48 mm
Standard Deviation 1.96
|
3.14 mm
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, 10 years postoperativelyPopulation: The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment.
Safety: \- Frequency of serious device related complications.
Outcome measures
| Measure |
Stanmore
n=11 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=9 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
Number of Reported Device Related Complications
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperativelyPopulation: The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the Harris Hip Score was performed for all fully completed score forms.
Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)
Outcome measures
| Measure |
Stanmore
n=11 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=9 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
Harris Hip Score
Pre-operatively
|
50.5 Scores on a scale
Standard Deviation 12.0
|
64.0 Scores on a scale
Standard Deviation 10.3
|
|
Harris Hip Score
6 weeks postoperatively
|
90.5 Scores on a scale
Standard Deviation 9.6
|
83.8 Scores on a scale
Standard Deviation 10.3
|
|
Harris Hip Score
3 months postoperatively
|
91.3 Scores on a scale
Standard Deviation 7.6
|
83.8 Scores on a scale
Standard Deviation 12.2
|
|
Harris Hip Score
6 months postoperatively
|
94.8 Scores on a scale
Standard Deviation 6.4
|
82.2 Scores on a scale
Standard Deviation 18.8
|
|
Harris Hip Score
1 year postoperatively
|
95.6 Scores on a scale
Standard Deviation 5.7
|
80.6 Scores on a scale
Standard Deviation 20.7
|
|
Harris Hip Score
2 years postoperatively
|
94.9 Scores on a scale
Standard Deviation 1.8
|
81.0 Scores on a scale
Standard Deviation 15.6
|
|
Harris Hip Score
3 years postoperatively
|
94.9 Scores on a scale
Standard Deviation 1.8
|
95.9 Scores on a scale
Standard Deviation 0.0
|
|
Harris Hip Score
4 years postoperatively
|
92.0 Scores on a scale
Standard Deviation 8.6
|
85.2 Scores on a scale
Standard Deviation 18.5
|
|
Harris Hip Score
5 years postoperatively
|
94.6 Scores on a scale
Standard Deviation 2.3
|
91.6 Scores on a scale
Standard Deviation 5.9
|
|
Harris Hip Score
6 years postoperatively
|
93.6 Scores on a scale
Standard Deviation 4.0
|
77.4 Scores on a scale
Standard Deviation 3.5
|
|
Harris Hip Score
7 years postoperatively
|
92.7 Scores on a scale
Standard Deviation 2.9
|
—
|
|
Harris Hip Score
10 years postoperatively
|
87.5 Scores on a scale
Standard Deviation 14.5
|
96.0 Scores on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 1 and 2 years postoperativePopulation: The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Percentage of change was calculated for all participants that have paired results available (6 week and 1 year or 6 week and 2 year). For MHP stem only 5 Gruen Zones were defined, so no information available for zone 6 and 7.
Efficacy: Bone density measured using the average DEXA score in each zone. For the long Stanmore the 7 Gruen zones were defined. For the short MHP stem an adjusted model with only 5 zones was used. The scan at 6 weeks is used as the baseline measurement to analyze if the bone density changes in the following years. At 1 year and 2 year follow up, percentual change is presented for both groups with respect to the 6 weeks DEXA score
Outcome measures
| Measure |
Stanmore
n=8 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=6 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
DEXA
Zone 1 - 1 year PO
|
10.8 percentage of change
Standard Deviation 51.4
|
6.8 percentage of change
Standard Deviation 54.7
|
|
DEXA
Zone 1 - 2 year PO
|
-4.8 percentage of change
Standard Deviation 11.4
|
-8.1 percentage of change
Standard Deviation 34.1
|
|
DEXA
Zone 2 - 1 year PO
|
-8.1 percentage of change
Standard Deviation 17.7
|
-17.7 percentage of change
Standard Deviation 26.7
|
|
DEXA
Zone 2 - 2 year PO
|
-2.0 percentage of change
Standard Deviation 4.5
|
-6.3 percentage of change
Standard Deviation 32.3
|
|
DEXA
Zone 3 - 1 year PO
|
-3.5 percentage of change
Standard Deviation 7.2
|
-7.4 percentage of change
Standard Deviation 15.4
|
|
DEXA
Zone 3 - 2 year PO
|
-3.5 percentage of change
Standard Deviation 7.2
|
-9.9 percentage of change
Standard Deviation 14.3
|
|
DEXA
Zone 4 - 1 year PO
|
4.3 percentage of change
Standard Deviation 5.0
|
-0.8 percentage of change
Standard Deviation 35.2
|
|
DEXA
Zone 4 - 2 year PO
|
0.3 percentage of change
Standard Deviation 13.2
|
-4.5 percentage of change
Standard Deviation 37.9
|
|
DEXA
Zone 5 - 1 year PO
|
4.4 percentage of change
Standard Deviation 6.1
|
-21.3 percentage of change
Standard Deviation 28.7
|
|
DEXA
Zone 5 - 2 year PO
|
6.5 percentage of change
Standard Deviation 10.6
|
-19.1 percentage of change
Standard Deviation 35.9
|
|
DEXA
Zone 6 - 1 year PO
|
2.0 percentage of change
Standard Deviation 5.9
|
—
|
|
DEXA
Zone 6 - 2 year PO
|
-1.7 percentage of change
Standard Deviation 9.4
|
—
|
|
DEXA
Zone 7 - 1 year PO
|
8.4 percentage of change
Standard Deviation 27.7
|
—
|
|
DEXA
Zone 7 - 2 year PO
|
8.4 percentage of change
Standard Deviation 27.7
|
—
|
SECONDARY outcome
Timeframe: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperativelyPopulation: The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.
HOOS (Hip disability and Osteoarthritis Outcome Score) consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Outcome measures
| Measure |
Stanmore
n=10 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=9 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
HOOS-Pain Subscale
Pre-operatively
|
44.4 units on a scale
Standard Deviation 19.7
|
51.7 units on a scale
Standard Deviation 27.8
|
|
HOOS-Pain Subscale
6 weeks postoperatively
|
84.2 units on a scale
Standard Deviation 11.3
|
74.7 units on a scale
Standard Deviation 23.3
|
|
HOOS-Pain Subscale
3 months postoperatively
|
78.6 units on a scale
Standard Deviation 15.1
|
76.1 units on a scale
Standard Deviation 21.8
|
|
HOOS-Pain Subscale
6 months postoperatively
|
87.2 units on a scale
Standard Deviation 21.3
|
73.9 units on a scale
Standard Deviation 24.7
|
|
HOOS-Pain Subscale
1 year postoperatively
|
95.8 units on a scale
Standard Deviation 8.0
|
78.2 units on a scale
Standard Deviation 29.5
|
|
HOOS-Pain Subscale
2 years postoperatively
|
84.8 units on a scale
Standard Deviation 18.2
|
84.7 units on a scale
Standard Deviation 27.6
|
|
HOOS-Pain Subscale
3 years postoperatively
|
86.1 units on a scale
Standard Deviation 16.8
|
100.0 units on a scale
Standard Deviation 0.0
|
|
HOOS-Pain Subscale
4 years postoperatively
|
88.5 units on a scale
Standard Deviation 16.6
|
87.5 units on a scale
Standard Deviation 25.0
|
|
HOOS-Pain Subscale
5 years postoperatively
|
87.8 units on a scale
Standard Deviation 16.7
|
98.3 units on a scale
Standard Deviation 2.9
|
|
HOOS-Pain Subscale
6 years postoperatively
|
80.0 units on a scale
Standard Deviation 26.3
|
89.4 units on a scale
Standard Deviation 21.3
|
|
HOOS-Pain Subscale
7 years postoperatively
|
91.1 units on a scale
Standard Deviation 7.5
|
91.3 units on a scale
Standard Deviation 17.5
|
|
HOOS-Pain Subscale
10 years postoperatively
|
86.5 units on a scale
Standard Deviation 17.6
|
100.0 units on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperativelyPopulation: The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.
HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Outcome measures
| Measure |
Stanmore
n=11 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=9 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
HOOS-Symptom Subscale
Pre-operatively
|
39.5 units on a scale
Standard Deviation 16.2
|
57.2 units on a scale
Standard Deviation 25.0
|
|
HOOS-Symptom Subscale
6 weeks postoperatively
|
74.4 units on a scale
Standard Deviation 14.4
|
63.1 units on a scale
Standard Deviation 22.7
|
|
HOOS-Symptom Subscale
3 months postoperatively
|
68.8 units on a scale
Standard Deviation 18.5
|
70.7 units on a scale
Standard Deviation 19.0
|
|
HOOS-Symptom Subscale
6 months postoperatively
|
76.0 units on a scale
Standard Deviation 22.8
|
75.0 units on a scale
Standard Deviation 16.8
|
|
HOOS-Symptom Subscale
1 year postoperatively
|
89.0 units on a scale
Standard Deviation 11.0
|
70.7 units on a scale
Standard Deviation 31.5
|
|
HOOS-Symptom Subscale
2 years postoperatively
|
85.0 units on a scale
Standard Deviation 11.5
|
86.7 units on a scale
Standard Deviation 14.7
|
|
HOOS-Symptom Subscale
3 years postoperatively
|
84.7 units on a scale
Standard Deviation 16.4
|
96.7 units on a scale
Standard Deviation 5.8
|
|
HOOS-Symptom Subscale
4 years postoperatively
|
85.0 units on a scale
Standard Deviation 14.4
|
82.5 units on a scale
Standard Deviation 25.3
|
|
HOOS-Symptom Subscale
5 years postoperatively
|
90.8 units on a scale
Standard Deviation 9.4
|
96.7 units on a scale
Standard Deviation 5.8
|
|
HOOS-Symptom Subscale
7 years postoperatively
|
90.7 units on a scale
Standard Deviation 6.7
|
83.8 units on a scale
Standard Deviation 20.2
|
|
HOOS-Symptom Subscale
10 years postoperatively
|
82.0 units on a scale
Standard Deviation 15.2
|
81.7 units on a scale
Standard Deviation 16.1
|
SECONDARY outcome
Timeframe: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperativelyPopulation: The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.
HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Outcome measures
| Measure |
Stanmore
n=11 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=9 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
HOOS-ADL Subscale
Pre-operatively
|
46.6 units on a scale
Standard Deviation 17.8
|
52.4 units on a scale
Standard Deviation 27.7
|
|
HOOS-ADL Subscale
6 weeks postoperatively
|
76.4 units on a scale
Standard Deviation 14.5
|
77.77 units on a scale
Standard Deviation 28.0
|
|
HOOS-ADL Subscale
3 months postoperatively
|
81.4 units on a scale
Standard Deviation 15.6
|
78.0 units on a scale
Standard Deviation 23.5
|
|
HOOS-ADL Subscale
6 months postoperatively
|
84.5 units on a scale
Standard Deviation 16.7
|
75.6 units on a scale
Standard Deviation 23.5
|
|
HOOS-ADL Subscale
1 year postoperatively
|
92.2 units on a scale
Standard Deviation 8.5
|
73.7 units on a scale
Standard Deviation 31.8
|
|
HOOS-ADL Subscale
2 years postoperatively
|
86.2 units on a scale
Standard Deviation 14.0
|
90.9 units on a scale
Standard Deviation 17.5
|
|
HOOS-ADL Subscale
3 years postoperatively
|
87.8 units on a scale
Standard Deviation 15.1
|
100.0 units on a scale
Standard Deviation 0.0
|
|
HOOS-ADL Subscale
4 years postoperatively
|
87.7 units on a scale
Standard Deviation 15.4
|
90.4 units on a scale
Standard Deviation 19.2
|
|
HOOS-ADL Subscale
5 years postoperatively
|
88.4 units on a scale
Standard Deviation 17.2
|
99.0 units on a scale
Standard Deviation 1.7
|
|
HOOS-ADL Subscale
6 years postoperatively
|
82.8 units on a scale
Standard Deviation 23.9
|
91.5 units on a scale
Standard Deviation 16.9
|
|
HOOS-ADL Subscale
7 years postoperatively
|
91.0 units on a scale
Standard Deviation 8.8
|
90.1 units on a scale
Standard Deviation 19.9
|
|
HOOS-ADL Subscale
10 years postoperatively
|
81.6 units on a scale
Standard Deviation 21.6
|
95.8 units on a scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperativelyPopulation: The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.
HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Outcome measures
| Measure |
Stanmore
n=11 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=9 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
HOOS-Sport Subscale
2 years postoperatively
|
68.8 units on a scale
Standard Deviation 21.0
|
80.0 units on a scale
Standard Deviation 30.4
|
|
HOOS-Sport Subscale
3 years postoperatively
|
73.4 units on a scale
Standard Deviation 27.4
|
100.0 units on a scale
Standard Deviation 0.0
|
|
HOOS-Sport Subscale
4 years postoperatively
|
71.9 units on a scale
Standard Deviation 23.9
|
70.8 units on a scale
Standard Deviation 50.5
|
|
HOOS-Sport Subscale
Pre-operatively
|
27.3 units on a scale
Standard Deviation 17.5
|
26.6 units on a scale
Standard Deviation 21.8
|
|
HOOS-Sport Subscale
6 weeks postoperatively
|
56.3 units on a scale
Standard Deviation 25.3
|
40.3 units on a scale
Standard Deviation 30.7
|
|
HOOS-Sport Subscale
3 months postoperatively
|
59.4 units on a scale
Standard Deviation 29.3
|
50.0 units on a scale
Standard Deviation 33.8
|
|
HOOS-Sport Subscale
6 months postoperatively
|
63.1 units on a scale
Standard Deviation 28.8
|
48.3 units on a scale
Standard Deviation 37.0
|
|
HOOS-Sport Subscale
1 year postoperatively
|
75.8 units on a scale
Standard Deviation 25.3
|
41.7 units on a scale
Standard Deviation 30.8
|
|
HOOS-Sport Subscale
5 years postoperatively
|
71.9 units on a scale
Standard Deviation 23.9
|
100.0 units on a scale
|
|
HOOS-Sport Subscale
6 years postoperatively
|
67.7 units on a scale
Standard Deviation 41.9
|
62.5 units on a scale
Standard Deviation 53.0
|
|
HOOS-Sport Subscale
7 years postoperatively
|
69.9 units on a scale
Standard Deviation 19.0
|
71.9 units on a scale
Standard Deviation 39.8
|
|
HOOS-Sport Subscale
10 years postoperatively
|
59.2 units on a scale
Standard Deviation 28.6
|
100.0 units on a scale
|
SECONDARY outcome
Timeframe: pre-operatively, 6 weeks, 3 months, 6 months, 1,2, 3, 4, 5, 6, 7, and 10 years postoperativelyPopulation: The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.
HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Outcome measures
| Measure |
Stanmore
n=11 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=9 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
HOOS-QoL Subscale
10 years postoperatively
|
88.3 units on a scale
Standard Deviation 14.3
|
93.8 units on a scale
Standard Deviation 10.8
|
|
HOOS-QoL Subscale
Pre-operatively
|
34.8 units on a scale
Standard Deviation 14.6
|
34.5 units on a scale
Standard Deviation 26.5
|
|
HOOS-QoL Subscale
6 weeks postoperatively
|
60.2 units on a scale
Standard Deviation 15.7
|
60.1 units on a scale
Standard Deviation 31.0
|
|
HOOS-QoL Subscale
3 months postoperatively
|
59.4 units on a scale
Standard Deviation 23.4
|
62.5 units on a scale
Standard Deviation 40.8
|
|
HOOS-QoL Subscale
6 months postoperatively
|
74.6 units on a scale
Standard Deviation 22.8
|
59.8 units on a scale
Standard Deviation 38.7
|
|
HOOS-QoL Subscale
1 year postoperatively
|
89.8 units on a scale
Standard Deviation 16.0
|
68.8 units on a scale
Standard Deviation 40.3
|
|
HOOS-QoL Subscale
2 years postoperatively
|
81.9 units on a scale
Standard Deviation 19.6
|
81.9 units on a scale
Standard Deviation 40.3
|
|
HOOS-QoL Subscale
3 years postoperatively
|
80.6 units on a scale
Standard Deviation 28.7
|
100.0 units on a scale
Standard Deviation 0.0
|
|
HOOS-QoL Subscale
4 years postoperatively
|
84.0 units on a scale
Standard Deviation 18.0
|
75.0 units on a scale
Standard Deviation 50.0
|
|
HOOS-QoL Subscale
5 years postoperatively
|
86.8 units on a scale
Standard Deviation 18.6
|
100.0 units on a scale
Standard Deviation 0.0
|
|
HOOS-QoL Subscale
6 years postoperatively
|
100.0 units on a scale
Standard Deviation 0.0
|
78.1 units on a scale
Standard Deviation 43.8
|
|
HOOS-QoL Subscale
7 years postoperatively
|
92.9 units on a scale
Standard Deviation 14.2
|
75.0 units on a scale
Standard Deviation 50.0
|
SECONDARY outcome
Timeframe: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperativelyPopulation: The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the SF-12 Score was performed for all fully completed score forms.
12-Item Short-Form Health Survey (SF-12) presented in Physical (PS) and Mental summary (MS) scores (range 0-100). A zero score indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
Stanmore
n=11 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=9 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
SF-12 Physical Summary Score
6 months postoperatively
|
46.5 units on a scale
Standard Deviation 8.0
|
42.7 units on a scale
Standard Deviation 11.0
|
|
SF-12 Physical Summary Score
1 year postoperatively
|
51.6 units on a scale
Standard Deviation 4.5
|
48.7 units on a scale
Standard Deviation 8.2
|
|
SF-12 Physical Summary Score
Pre-operatively
|
34.7 units on a scale
Standard Deviation 6.4
|
37.3 units on a scale
Standard Deviation 8.7
|
|
SF-12 Physical Summary Score
6 weeks postoperatively
|
44.2 units on a scale
Standard Deviation 7.3
|
41.3 units on a scale
Standard Deviation 9.0
|
|
SF-12 Physical Summary Score
3 months postoperatively
|
42.4 units on a scale
Standard Deviation 7.3
|
43.0 units on a scale
Standard Deviation 12.5
|
|
SF-12 Physical Summary Score
2 years postoperatively
|
48.4 units on a scale
Standard Deviation 8.9
|
54.4 units on a scale
Standard Deviation 3.1
|
|
SF-12 Physical Summary Score
3 years postoperatively
|
47.3 units on a scale
Standard Deviation 9.6
|
53.3 units on a scale
Standard Deviation 3.5
|
|
SF-12 Physical Summary Score
4 years postoperatively
|
45.9 units on a scale
Standard Deviation 6.7
|
50.6 units on a scale
Standard Deviation 7.5
|
|
SF-12 Physical Summary Score
5 years postoperatively
|
49.2 units on a scale
Standard Deviation 7.7
|
53.6 units on a scale
Standard Deviation 3.1
|
|
SF-12 Physical Summary Score
6 years postoperatively
|
41.2 units on a scale
Standard Deviation 7.7
|
49.1 units on a scale
Standard Deviation 8.8
|
|
SF-12 Physical Summary Score
7 years postoperatively
|
48.1 units on a scale
Standard Deviation 6.4
|
46.3 units on a scale
Standard Deviation 9.7
|
|
SF-12 Physical Summary Score
10 years postoperatively
|
48.4 units on a scale
Standard Deviation 7.5
|
48.4 units on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperativelyPopulation: The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the SF-12 Score was performed for all fully completed score forms.
SF-12 Score presented in Physical and Mental summary scores (range 0-100). A zero score indicates the lowest level of health and 100 indicates the highest level of health.
Outcome measures
| Measure |
Stanmore
n=11 Participants
Cemented Stanmore hip stem
|
MHP Hip Stem
n=9 Participants
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
SF-12 Mental Summary Score
Pre-operatively
|
53.7 units on a scale
Standard Deviation 7.6
|
53.5 units on a scale
Standard Deviation 12.4
|
|
SF-12 Mental Summary Score
6 weeks postoperatively
|
56.9 units on a scale
Standard Deviation 3.7
|
50.8 units on a scale
Standard Deviation 11.6
|
|
SF-12 Mental Summary Score
3 months postoperatively
|
59.7 units on a scale
Standard Deviation 2.8
|
53.1 units on a scale
Standard Deviation 9.4
|
|
SF-12 Mental Summary Score
6 months postoperatively
|
59.0 units on a scale
Standard Deviation 3.5
|
49.1 units on a scale
Standard Deviation 9.4
|
|
SF-12 Mental Summary Score
1 year postoperatively
|
56.5 units on a scale
Standard Deviation 8.1
|
50.1 units on a scale
Standard Deviation 11.7
|
|
SF-12 Mental Summary Score
2 years postoperatively
|
57.5 units on a scale
Standard Deviation 6.3
|
55.4 units on a scale
Standard Deviation 6.8
|
|
SF-12 Mental Summary Score
3 years postoperatively
|
58.8 units on a scale
Standard Deviation 7.9
|
59.8 units on a scale
Standard Deviation 1.6
|
|
SF-12 Mental Summary Score
4 years postoperatively
|
60.5 units on a scale
Standard Deviation 3.0
|
57.0 units on a scale
Standard Deviation 7.1
|
|
SF-12 Mental Summary Score
5 years postoperatively
|
52.7 units on a scale
Standard Deviation 7.6
|
57.7 units on a scale
Standard Deviation 4.0
|
|
SF-12 Mental Summary Score
6 years postoperatively
|
54.1 units on a scale
Standard Deviation 10.3
|
57.2 units on a scale
Standard Deviation 5.6
|
|
SF-12 Mental Summary Score
7 years postoperatively
|
56.8 units on a scale
Standard Deviation 2.9
|
52.4 units on a scale
Standard Deviation 10.1
|
|
SF-12 Mental Summary Score
10 years postoperatively
|
53.6 units on a scale
Standard Deviation 10.8
|
58.9 units on a scale
Standard Deviation 0.8
|
Adverse Events
Stanmore
MHP Hip Stem
Serious adverse events
| Measure |
Stanmore
n=11 participants at risk
Cemented Stanmore hip stem
|
MHP Hip Stem
n=9 participants at risk
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Stem revision
|
18.2%
2/11 • Number of events 2 • SAE´s collected up to 10 years post/operatively
The occurrence of adverse events was assessed at each follow up visit.
|
66.7%
6/9 • Number of events 6 • SAE´s collected up to 10 years post/operatively
The occurrence of adverse events was assessed at each follow up visit.
|
|
Cardiac disorders
Cardiac Disorder
|
9.1%
1/11 • Number of events 1 • SAE´s collected up to 10 years post/operatively
The occurrence of adverse events was assessed at each follow up visit.
|
11.1%
1/9 • Number of events 1 • SAE´s collected up to 10 years post/operatively
The occurrence of adverse events was assessed at each follow up visit.
|
|
Musculoskeletal and connective tissue disorders
Cup revision
|
9.1%
1/11 • Number of events 1 • SAE´s collected up to 10 years post/operatively
The occurrence of adverse events was assessed at each follow up visit.
|
0.00%
0/9 • SAE´s collected up to 10 years post/operatively
The occurrence of adverse events was assessed at each follow up visit.
|
Other adverse events
| Measure |
Stanmore
n=11 participants at risk
Cemented Stanmore hip stem
|
MHP Hip Stem
n=9 participants at risk
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Cortical Erosion/Osteolysis
|
18.2%
2/11 • Number of events 2 • SAE´s collected up to 10 years post/operatively
The occurrence of adverse events was assessed at each follow up visit.
|
0.00%
0/9 • SAE´s collected up to 10 years post/operatively
The occurrence of adverse events was assessed at each follow up visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in groin During Weigth Bearing
|
0.00%
0/11 • SAE´s collected up to 10 years post/operatively
The occurrence of adverse events was assessed at each follow up visit.
|
22.2%
2/9 • Number of events 2 • SAE´s collected up to 10 years post/operatively
The occurrence of adverse events was assessed at each follow up visit.
|
|
Infections and infestations
Superficial Infection Wound
|
9.1%
1/11 • Number of events 1 • SAE´s collected up to 10 years post/operatively
The occurrence of adverse events was assessed at each follow up visit.
|
0.00%
0/9 • SAE´s collected up to 10 years post/operatively
The occurrence of adverse events was assessed at each follow up visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place