Osteoarthritis of the Hip
Conditions
Keywords
Osteoarthritis
Brief summary
The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement.
Detailed description
The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement at short term (1 year) and long term (10 years). Bone remodeling will be analyzed at 10 years using DEXA (Dual Energy X-Ray Absorptiometry (bone scan test)) measurements. This is a single-center prospective study with 25 patients in the study and 25 in the control group in open Randomized Clinical Trial.
Interventions
DEVICEMetaphyseal Hip Prosthesis
Metaphyseal Hip Prosthesis (MHP) hip replacement
DEVICEStanmore
Stanmore hip prosthesis
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Candidates for a total hip replacement because of arthritis of the hip * Patients with a good general condition * Patients willing and able to participate in the clinical trial with a 10 years follow up and who have signed an inform consent * Males and females * Age between 55 and 75 * Absence or little presence of osteoporotic bone (t\>-2) * ASA score 1 and 2
Exclusion criteria
* Patient with co morbidities that limit the physical abilities which may negatively influence the scores. Such co morbidities can for example be cardiac insufficiency or chronic respiratory diseases. * Severe systematic diseases such as rheumatic arthritis and SLE. * General osteoporosis (t\<-2). * Hormonal conditions such as Paget disease, which reduces the bone density. * Diseases that can negatively influence the 10 years life expectancy. * Chronic use of corticosteroids. * Extreme overweight defined as BMI above 35. * Active bacterial infection. * Mental weakness which could negatively influence the postoperative recovery and influence the ability to complete pain scores and other questionnaires. * ASA score \>2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RSA Translation X | 3 months, 6 months, 1 year and 2 years postoperatively | 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. |
| RSA Translation Y | 3 months, 6 months, 1 year and 2 years postoperatively | Stem movement along the y-axis in mm. (measured with RSA) |
| RSA Translation Z | 3 months, 6 months, 1 year and 2 years postoperatively | Stem movement along z-axis in mm (measured with RSA) |
| RSA Rotation X | 3 months, 6 months, 1 year and 2 years postoperatively | Stem Rotation around X-axis in degrees (measured with RSA) |
| RSA Rotation Y | 3 months, 6 months, 1 year and 2 years postoperatively | Stem rotation around the y-axis in degrees ( measured with RSA) |
| RSA Rotation Z | 3 months, 6 months, 1 year and 2 years postoperatively | Stem rotation around the z-axis in degrees (measured with RSA) |
| RSA MTMP | 3 months, 6 months, 1 year and 2 years postoperatively | Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HOOS-QoL Subscale | pre-operatively, 6 weeks, 3 months, 6 months, 1,2, 3, 4, 5, 6, 7, and 10 years postoperatively | 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. |
| Number of Reported Device Related Complications | 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, 10 years postoperatively | Safety: \- Frequency of serious device related complications. |
| SF-12 Mental Summary Score | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively | 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. |
| SF-12 Physical Summary Score | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively | 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. |
| Harris Hip Score | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively | 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) |
| DEXA | 1 and 2 years postoperative | 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 |
| HOOS-Pain Subscale | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively | 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. |
| HOOS-Symptom Subscale | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively | 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. |
| HOOS-ADL Subscale | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively | 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. |
| HOOS-Sport Subscale | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively | 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. |
Countries
Netherlands
Participant flow
Recruitment details
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-assignment details
Pre-operatively a DEXA scan was made to confirm eligibility.
Participants by arm
| Arm | Count |
|---|---|
| Stanmore Cemented Stanmore hip stem | 11 |
| MHP Hip Stem Cemented MHP (Metaphyseal Hip Prosthesis) hip stem | 9 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Stanmore | MHP Hip Stem | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 6 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Operative Side Left | 4 Participants | 3 Participants | 7 Participants |
| Operative Side Right | 7 Participants | 6 Participants | 13 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Netherlands | 11 participants | 9 participants | 20 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 11 | 0 / 9 |
| other Total, other adverse events | 2 / 11 | 2 / 9 |
| serious Total, serious adverse events | 2 / 11 | 7 / 9 |
Outcome results
Primary
RSA MTMP
Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem.
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | RSA MTMP | 1 y postoperatively | 1.76 mm | Standard Deviation 1.13 |
| Stanmore | RSA MTMP | 2 y postoperatively | 2.48 mm | Standard Deviation 1.96 |
| Stanmore | RSA MTMP | 3 m postoperatively | 1.44 mm | Standard Deviation 0.79 |
| Stanmore | RSA MTMP | 6 m postoperatively | 1.75 mm | Standard Deviation 1.3 |
| MHP Hip Stem | RSA MTMP | 6 m postoperatively | 1.34 mm | Standard Deviation 0.23 |
| MHP Hip Stem | RSA MTMP | 1 y postoperatively | 1.31 mm | Standard Deviation 1.22 |
| MHP Hip Stem | RSA MTMP | 3 m postoperatively | 0.81 mm | Standard Deviation 0.29 |
| MHP Hip Stem | RSA MTMP | 2 y postoperatively | 3.14 mm | Standard Deviation 2.29 |
Primary
RSA Rotation X
Stem Rotation around X-axis in degrees (measured with RSA)
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | RSA Rotation X | 3 m postoperatively | -0.22 mm | Standard Deviation 0.68 |
| Stanmore | RSA Rotation X | 1 y postoperatively | -0.27 mm | Standard Deviation 0.48 |
| Stanmore | RSA Rotation X | 6 m postoperatively | -0.18 mm | Standard Deviation 0.74 |
| Stanmore | RSA Rotation X | 2 y postoperatively | -0.42 mm | Standard Deviation 0.92 |
| MHP Hip Stem | RSA Rotation X | 6 m postoperatively | -0.23 mm | Standard Deviation 1.16 |
| MHP Hip Stem | RSA Rotation X | 3 m postoperatively | -0.18 mm | Standard Deviation 0.13 |
| MHP Hip Stem | RSA Rotation X | 2 y postoperatively | -1.18 mm | Standard Deviation 0.36 |
| MHP Hip Stem | RSA Rotation X | 1 y postoperatively | -0.44 mm | Standard Deviation 0.37 |
Primary
RSA Rotation Y
Stem rotation around the y-axis in degrees ( measured with RSA)
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | RSA Rotation Y | 3 m postoperatively | 0.57 mm | Standard Deviation 0.86 |
| Stanmore | RSA Rotation Y | 6 m postoperatively | 1.13 mm | Standard Deviation 1.36 |
| Stanmore | RSA Rotation Y | 1 y postoperatively | 1.43 mm | Standard Deviation 1.29 |
| Stanmore | RSA Rotation Y | 2 y postoperatively | 1.86 mm | Standard Deviation 2 |
| MHP Hip Stem | RSA Rotation Y | 2 y postoperatively | 1.50 mm | Standard Deviation 0.48 |
| MHP Hip Stem | RSA Rotation Y | 3 m postoperatively | 0.65 mm | Standard Deviation 0.59 |
| MHP Hip Stem | RSA Rotation Y | 1 y postoperatively | 0.52 mm | Standard Deviation 0.23 |
| MHP Hip Stem | RSA Rotation Y | 6 m postoperatively | 1.22 mm | Standard Deviation 1.44 |
Primary
RSA Rotation Z
Stem rotation around the z-axis in degrees (measured with RSA)
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | RSA Rotation Z | 2 y postoperatively | -0.08 mm | Standard Deviation 0.57 |
| Stanmore | RSA Rotation Z | 3 m postoperatively | -0.05 mm | Standard Deviation 0.28 |
| Stanmore | RSA Rotation Z | 6 m postoperatively | -0.01 mm | Standard Deviation 0.37 |
| Stanmore | RSA Rotation Z | 1 y postoperatively | -0.11 mm | Standard Deviation 0.41 |
| MHP Hip Stem | RSA Rotation Z | 1 y postoperatively | -0.71 mm | Standard Deviation 0.92 |
| MHP Hip Stem | RSA Rotation Z | 2 y postoperatively | -1.56 mm | Standard Deviation 1.55 |
| MHP Hip Stem | RSA Rotation Z | 6 m postoperatively | -0.35 mm | Standard Deviation 1.63 |
| MHP Hip Stem | RSA Rotation Z | 3 m postoperatively | -0.26 mm | Standard Deviation 0.46 |
Primary
RSA Translation X
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.
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | RSA Translation X | 3 m postoperatively | 0.05 mm | Standard Deviation 0.2 |
| Stanmore | RSA Translation X | 6 m postoperatively | 0.10 mm | Standard Deviation 0.29 |
| Stanmore | RSA Translation X | 1 y postoperatively | 0.13 mm | Standard Deviation 0.3 |
| Stanmore | RSA Translation X | 2 y postoperatively | 0.14 mm | Standard Deviation 0.42 |
| MHP Hip Stem | RSA Translation X | 2 y postoperatively | 0.21 mm | Standard Deviation 0.6 |
| MHP Hip Stem | RSA Translation X | 3 m postoperatively | 0.05 mm | Standard Deviation 0.26 |
| MHP Hip Stem | RSA Translation X | 1 y postoperatively | 0.08 mm | Standard Deviation 0.41 |
| MHP Hip Stem | RSA Translation X | 6 m postoperatively | 0.08 mm | Standard Deviation 0.35 |
Primary
RSA Translation Y
Stem movement along the y-axis in mm. (measured with RSA)
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | RSA Translation Y | 3 m postoperatively | -0.25 mm | Standard Deviation 0.34 |
| Stanmore | RSA Translation Y | 6 m postoperatively | -0.47 mm | Standard Deviation 0.5 |
| Stanmore | RSA Translation Y | 1 y postoperatively | -0.54 mm | Standard Deviation 0.67 |
| Stanmore | RSA Translation Y | 2 y postoperatively | -0.25 mm | Standard Deviation 0.22 |
| MHP Hip Stem | RSA Translation Y | 2 y postoperatively | -0.29 mm | Standard Deviation 0.43 |
| MHP Hip Stem | RSA Translation Y | 3 m postoperatively | -0.18 mm | Standard Deviation 0.22 |
| MHP Hip Stem | RSA Translation Y | 1 y postoperatively | -0.25 mm | Standard Deviation 0.24 |
| MHP Hip Stem | RSA Translation Y | 6 m postoperatively | -0.31 mm | Standard Deviation 0.28 |
Primary
RSA Translation Z
Stem movement along z-axis in mm (measured with RSA)
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | RSA Translation Z | 3 m postoperatively | -0.10 mm | Standard Deviation 0.36 |
| Stanmore | RSA Translation Z | 6 m postoperatively | -0.23 mm | Standard Deviation 0.45 |
| Stanmore | RSA Translation Z | 1 y postoperatively | -0.19 mm | Standard Deviation 0.23 |
| Stanmore | RSA Translation Z | 2 y postoperatively | -0.25 mm | Standard Deviation 0.22 |
| MHP Hip Stem | RSA Translation Z | 2 y postoperatively | -0.29 mm | Standard Deviation 0.43 |
| MHP Hip Stem | RSA Translation Z | 3 m postoperatively | -0.08 mm | Standard Deviation 0.24 |
| MHP Hip Stem | RSA Translation Z | 1 y postoperatively | -0.19 mm | Standard Deviation 0.3 |
| MHP Hip Stem | RSA Translation Z | 6 m postoperatively | -0.02 mm | Standard Deviation 0.19 |
Secondary
DEXA
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
Time frame: 1 and 2 years postoperative
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | DEXA | Zone 7 - 1 year PO | 8.4 percentage of change | Standard Deviation 27.7 |
| Stanmore | DEXA | Zone 7 - 2 year PO | 8.4 percentage of change | Standard Deviation 27.7 |
| Stanmore | DEXA | Zone 1 - 2 year PO | -4.8 percentage of change | Standard Deviation 11.4 |
| Stanmore | DEXA | Zone 2 - 2 year PO | -2.0 percentage of change | Standard Deviation 4.5 |
| Stanmore | DEXA | Zone 3 - 2 year PO | -3.5 percentage of change | Standard Deviation 7.2 |
| Stanmore | DEXA | Zone 4 - 2 year PO | 0.3 percentage of change | Standard Deviation 13.2 |
| Stanmore | DEXA | Zone 5 - 1 year PO | 4.4 percentage of change | Standard Deviation 6.1 |
| Stanmore | DEXA | Zone 5 - 2 year PO | 6.5 percentage of change | Standard Deviation 10.6 |
| Stanmore | DEXA | Zone 6 - 1 year PO | 2.0 percentage of change | Standard Deviation 5.9 |
| Stanmore | DEXA | Zone 6 - 2 year PO | -1.7 percentage of change | Standard Deviation 9.4 |
| Stanmore | DEXA | Zone 1 - 1 year PO | 10.8 percentage of change | Standard Deviation 51.4 |
| Stanmore | DEXA | Zone 2 - 1 year PO | -8.1 percentage of change | Standard Deviation 17.7 |
| Stanmore | DEXA | Zone 3 - 1 year PO | -3.5 percentage of change | Standard Deviation 7.2 |
| Stanmore | DEXA | Zone 4 - 1 year PO | 4.3 percentage of change | Standard Deviation 5 |
| MHP Hip Stem | DEXA | Zone 1 - 2 year PO | -8.1 percentage of change | Standard Deviation 34.1 |
| MHP Hip Stem | DEXA | Zone 5 - 1 year PO | -21.3 percentage of change | Standard Deviation 28.7 |
| MHP Hip Stem | DEXA | Zone 2 - 1 year PO | -17.7 percentage of change | Standard Deviation 26.7 |
| MHP Hip Stem | DEXA | Zone 2 - 2 year PO | -6.3 percentage of change | Standard Deviation 32.3 |
| MHP Hip Stem | DEXA | Zone 4 - 2 year PO | -4.5 percentage of change | Standard Deviation 37.9 |
| MHP Hip Stem | DEXA | Zone 3 - 1 year PO | -7.4 percentage of change | Standard Deviation 15.4 |
| MHP Hip Stem | DEXA | Zone 3 - 2 year PO | -9.9 percentage of change | Standard Deviation 14.3 |
| MHP Hip Stem | DEXA | Zone 5 - 2 year PO | -19.1 percentage of change | Standard Deviation 35.9 |
| MHP Hip Stem | DEXA | Zone 4 - 1 year PO | -0.8 percentage of change | Standard Deviation 35.2 |
| MHP Hip Stem | DEXA | Zone 1 - 1 year PO | 6.8 percentage of change | Standard Deviation 54.7 |
Secondary
Harris Hip Score
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)
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | Harris Hip Score | 1 year postoperatively | 95.6 Scores on a scale | Standard Deviation 5.7 |
| Stanmore | Harris Hip Score | 6 weeks postoperatively | 90.5 Scores on a scale | Standard Deviation 9.6 |
| Stanmore | Harris Hip Score | 2 years postoperatively | 94.9 Scores on a scale | Standard Deviation 1.8 |
| Stanmore | Harris Hip Score | 7 years postoperatively | 92.7 Scores on a scale | Standard Deviation 2.9 |
| Stanmore | Harris Hip Score | 3 years postoperatively | 94.9 Scores on a scale | Standard Deviation 1.8 |
| Stanmore | Harris Hip Score | 3 months postoperatively | 91.3 Scores on a scale | Standard Deviation 7.6 |
| Stanmore | Harris Hip Score | 4 years postoperatively | 92.0 Scores on a scale | Standard Deviation 8.6 |
| Stanmore | Harris Hip Score | Pre-operatively | 50.5 Scores on a scale | Standard Deviation 12 |
| Stanmore | Harris Hip Score | 5 years postoperatively | 94.6 Scores on a scale | Standard Deviation 2.3 |
| Stanmore | Harris Hip Score | 6 months postoperatively | 94.8 Scores on a scale | Standard Deviation 6.4 |
| Stanmore | Harris Hip Score | 6 years postoperatively | 93.6 Scores on a scale | Standard Deviation 4 |
| Stanmore | Harris Hip Score | 10 years postoperatively | 87.5 Scores on a scale | Standard Deviation 14.5 |
| MHP Hip Stem | Harris Hip Score | 6 months postoperatively | 82.2 Scores on a scale | Standard Deviation 18.8 |
| MHP Hip Stem | Harris Hip Score | 10 years postoperatively | 96.0 Scores on a scale | Standard Deviation 0.1 |
| MHP Hip Stem | Harris Hip Score | Pre-operatively | 64.0 Scores on a scale | Standard Deviation 10.3 |
| MHP Hip Stem | Harris Hip Score | 6 weeks postoperatively | 83.8 Scores on a scale | Standard Deviation 10.3 |
| MHP Hip Stem | Harris Hip Score | 3 months postoperatively | 83.8 Scores on a scale | Standard Deviation 12.2 |
| MHP Hip Stem | Harris Hip Score | 6 years postoperatively | 77.4 Scores on a scale | Standard Deviation 3.5 |
| MHP Hip Stem | Harris Hip Score | 1 year postoperatively | 80.6 Scores on a scale | Standard Deviation 20.7 |
| MHP Hip Stem | Harris Hip Score | 2 years postoperatively | 81.0 Scores on a scale | Standard Deviation 15.6 |
| MHP Hip Stem | Harris Hip Score | 3 years postoperatively | 95.9 Scores on a scale | Standard Deviation 0 |
| MHP Hip Stem | Harris Hip Score | 4 years postoperatively | 85.2 Scores on a scale | Standard Deviation 18.5 |
| MHP Hip Stem | Harris Hip Score | 5 years postoperatively | 91.6 Scores on a scale | Standard Deviation 5.9 |
Secondary
HOOS-ADL Subscale
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.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | HOOS-ADL Subscale | 7 years postoperatively | 91.0 units on a scale | Standard Deviation 8.8 |
| Stanmore | HOOS-ADL Subscale | 3 months postoperatively | 81.4 units on a scale | Standard Deviation 15.6 |
| Stanmore | HOOS-ADL Subscale | 1 year postoperatively | 92.2 units on a scale | Standard Deviation 8.5 |
| Stanmore | HOOS-ADL Subscale | 5 years postoperatively | 88.4 units on a scale | Standard Deviation 17.2 |
| Stanmore | HOOS-ADL Subscale | 6 years postoperatively | 82.8 units on a scale | Standard Deviation 23.9 |
| Stanmore | HOOS-ADL Subscale | 10 years postoperatively | 81.6 units on a scale | Standard Deviation 21.6 |
| Stanmore | HOOS-ADL Subscale | Pre-operatively | 46.6 units on a scale | Standard Deviation 17.8 |
| Stanmore | HOOS-ADL Subscale | 6 weeks postoperatively | 76.4 units on a scale | Standard Deviation 14.5 |
| Stanmore | HOOS-ADL Subscale | 6 months postoperatively | 84.5 units on a scale | Standard Deviation 16.7 |
| Stanmore | HOOS-ADL Subscale | 2 years postoperatively | 86.2 units on a scale | Standard Deviation 14 |
| Stanmore | HOOS-ADL Subscale | 3 years postoperatively | 87.8 units on a scale | Standard Deviation 15.1 |
| Stanmore | HOOS-ADL Subscale | 4 years postoperatively | 87.7 units on a scale | Standard Deviation 15.4 |
| MHP Hip Stem | HOOS-ADL Subscale | 3 years postoperatively | 100.0 units on a scale | Standard Deviation 0 |
| MHP Hip Stem | HOOS-ADL Subscale | Pre-operatively | 52.4 units on a scale | Standard Deviation 27.7 |
| MHP Hip Stem | HOOS-ADL Subscale | 6 months postoperatively | 75.6 units on a scale | Standard Deviation 23.5 |
| MHP Hip Stem | HOOS-ADL Subscale | 2 years postoperatively | 90.9 units on a scale | Standard Deviation 17.5 |
| MHP Hip Stem | HOOS-ADL Subscale | 4 years postoperatively | 90.4 units on a scale | Standard Deviation 19.2 |
| MHP Hip Stem | HOOS-ADL Subscale | 3 months postoperatively | 78.0 units on a scale | Standard Deviation 23.5 |
| MHP Hip Stem | HOOS-ADL Subscale | 5 years postoperatively | 99.0 units on a scale | Standard Deviation 1.7 |
| MHP Hip Stem | HOOS-ADL Subscale | 6 weeks postoperatively | 77.77 units on a scale | Standard Deviation 28 |
| MHP Hip Stem | HOOS-ADL Subscale | 6 years postoperatively | 91.5 units on a scale | Standard Deviation 16.9 |
| MHP Hip Stem | HOOS-ADL Subscale | 7 years postoperatively | 90.1 units on a scale | Standard Deviation 19.9 |
| MHP Hip Stem | HOOS-ADL Subscale | 1 year postoperatively | 73.7 units on a scale | Standard Deviation 31.8 |
| MHP Hip Stem | HOOS-ADL Subscale | 10 years postoperatively | 95.8 units on a scale | Standard Deviation 7.2 |
Secondary
HOOS-Pain Subscale
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.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | HOOS-Pain Subscale | Pre-operatively | 44.4 units on a scale | Standard Deviation 19.7 |
| Stanmore | HOOS-Pain Subscale | 3 months postoperatively | 78.6 units on a scale | Standard Deviation 15.1 |
| Stanmore | HOOS-Pain Subscale | 1 year postoperatively | 95.8 units on a scale | Standard Deviation 8 |
| Stanmore | HOOS-Pain Subscale | 2 years postoperatively | 84.8 units on a scale | Standard Deviation 18.2 |
| Stanmore | HOOS-Pain Subscale | 3 years postoperatively | 86.1 units on a scale | Standard Deviation 16.8 |
| Stanmore | HOOS-Pain Subscale | 5 years postoperatively | 87.8 units on a scale | Standard Deviation 16.7 |
| Stanmore | HOOS-Pain Subscale | 6 years postoperatively | 80.0 units on a scale | Standard Deviation 26.3 |
| Stanmore | HOOS-Pain Subscale | 7 years postoperatively | 91.1 units on a scale | Standard Deviation 7.5 |
| Stanmore | HOOS-Pain Subscale | 10 years postoperatively | 86.5 units on a scale | Standard Deviation 17.6 |
| Stanmore | HOOS-Pain Subscale | 6 weeks postoperatively | 84.2 units on a scale | Standard Deviation 11.3 |
| Stanmore | HOOS-Pain Subscale | 6 months postoperatively | 87.2 units on a scale | Standard Deviation 21.3 |
| Stanmore | HOOS-Pain Subscale | 4 years postoperatively | 88.5 units on a scale | Standard Deviation 16.6 |
| MHP Hip Stem | HOOS-Pain Subscale | 6 months postoperatively | 73.9 units on a scale | Standard Deviation 24.7 |
| MHP Hip Stem | HOOS-Pain Subscale | Pre-operatively | 51.7 units on a scale | Standard Deviation 27.8 |
| MHP Hip Stem | HOOS-Pain Subscale | 6 weeks postoperatively | 74.7 units on a scale | Standard Deviation 23.3 |
| MHP Hip Stem | HOOS-Pain Subscale | 6 years postoperatively | 89.4 units on a scale | Standard Deviation 21.3 |
| MHP Hip Stem | HOOS-Pain Subscale | 3 months postoperatively | 76.1 units on a scale | Standard Deviation 21.8 |
| MHP Hip Stem | HOOS-Pain Subscale | 1 year postoperatively | 78.2 units on a scale | Standard Deviation 29.5 |
| MHP Hip Stem | HOOS-Pain Subscale | 7 years postoperatively | 91.3 units on a scale | Standard Deviation 17.5 |
| MHP Hip Stem | HOOS-Pain Subscale | 2 years postoperatively | 84.7 units on a scale | Standard Deviation 27.6 |
| MHP Hip Stem | HOOS-Pain Subscale | 4 years postoperatively | 87.5 units on a scale | Standard Deviation 25 |
| MHP Hip Stem | HOOS-Pain Subscale | 3 years postoperatively | 100.0 units on a scale | Standard Deviation 0 |
| MHP Hip Stem | HOOS-Pain Subscale | 10 years postoperatively | 100.0 units on a scale | Standard Deviation 0 |
| MHP Hip Stem | HOOS-Pain Subscale | 5 years postoperatively | 98.3 units on a scale | Standard Deviation 2.9 |
Secondary
HOOS-QoL Subscale
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.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1,2, 3, 4, 5, 6, 7, and 10 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | HOOS-QoL Subscale | Pre-operatively | 34.8 units on a scale | Standard Deviation 14.6 |
| Stanmore | HOOS-QoL Subscale | 6 weeks postoperatively | 60.2 units on a scale | Standard Deviation 15.7 |
| Stanmore | HOOS-QoL Subscale | 6 months postoperatively | 74.6 units on a scale | Standard Deviation 22.8 |
| Stanmore | HOOS-QoL Subscale | 1 year postoperatively | 89.8 units on a scale | Standard Deviation 16 |
| Stanmore | HOOS-QoL Subscale | 3 months postoperatively | 59.4 units on a scale | Standard Deviation 23.4 |
| Stanmore | HOOS-QoL Subscale | 2 years postoperatively | 81.9 units on a scale | Standard Deviation 19.6 |
| Stanmore | HOOS-QoL Subscale | 3 years postoperatively | 80.6 units on a scale | Standard Deviation 28.7 |
| Stanmore | HOOS-QoL Subscale | 4 years postoperatively | 84.0 units on a scale | Standard Deviation 18 |
| Stanmore | HOOS-QoL Subscale | 5 years postoperatively | 86.8 units on a scale | Standard Deviation 18.6 |
| Stanmore | HOOS-QoL Subscale | 6 years postoperatively | 100.0 units on a scale | Standard Deviation 0 |
| Stanmore | HOOS-QoL Subscale | 7 years postoperatively | 92.9 units on a scale | Standard Deviation 14.2 |
| Stanmore | HOOS-QoL Subscale | 10 years postoperatively | 88.3 units on a scale | Standard Deviation 14.3 |
| MHP Hip Stem | HOOS-QoL Subscale | 7 years postoperatively | 75.0 units on a scale | Standard Deviation 50 |
| MHP Hip Stem | HOOS-QoL Subscale | Pre-operatively | 34.5 units on a scale | Standard Deviation 26.5 |
| MHP Hip Stem | HOOS-QoL Subscale | 3 years postoperatively | 100.0 units on a scale | Standard Deviation 0 |
| MHP Hip Stem | HOOS-QoL Subscale | 6 years postoperatively | 78.1 units on a scale | Standard Deviation 43.8 |
| MHP Hip Stem | HOOS-QoL Subscale | 6 months postoperatively | 59.8 units on a scale | Standard Deviation 38.7 |
| MHP Hip Stem | HOOS-QoL Subscale | 4 years postoperatively | 75.0 units on a scale | Standard Deviation 50 |
| MHP Hip Stem | HOOS-QoL Subscale | 6 weeks postoperatively | 60.1 units on a scale | Standard Deviation 31 |
| MHP Hip Stem | HOOS-QoL Subscale | 10 years postoperatively | 93.8 units on a scale | Standard Deviation 10.8 |
| MHP Hip Stem | HOOS-QoL Subscale | 3 months postoperatively | 62.5 units on a scale | Standard Deviation 40.8 |
| MHP Hip Stem | HOOS-QoL Subscale | 1 year postoperatively | 68.8 units on a scale | Standard Deviation 40.3 |
| MHP Hip Stem | HOOS-QoL Subscale | 5 years postoperatively | 100.0 units on a scale | Standard Deviation 0 |
| MHP Hip Stem | HOOS-QoL Subscale | 2 years postoperatively | 81.9 units on a scale | Standard Deviation 40.3 |
Secondary
HOOS-Sport Subscale
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.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | HOOS-Sport Subscale | 7 years postoperatively | 69.9 units on a scale | Standard Deviation 19 |
| Stanmore | HOOS-Sport Subscale | 4 years postoperatively | 71.9 units on a scale | Standard Deviation 23.9 |
| Stanmore | HOOS-Sport Subscale | 10 years postoperatively | 59.2 units on a scale | Standard Deviation 28.6 |
| Stanmore | HOOS-Sport Subscale | 6 weeks postoperatively | 56.3 units on a scale | Standard Deviation 25.3 |
| Stanmore | HOOS-Sport Subscale | 3 months postoperatively | 59.4 units on a scale | Standard Deviation 29.3 |
| Stanmore | HOOS-Sport Subscale | 6 months postoperatively | 63.1 units on a scale | Standard Deviation 28.8 |
| Stanmore | HOOS-Sport Subscale | 1 year postoperatively | 75.8 units on a scale | Standard Deviation 25.3 |
| Stanmore | HOOS-Sport Subscale | 2 years postoperatively | 68.8 units on a scale | Standard Deviation 21 |
| Stanmore | HOOS-Sport Subscale | 3 years postoperatively | 73.4 units on a scale | Standard Deviation 27.4 |
| Stanmore | HOOS-Sport Subscale | 5 years postoperatively | 71.9 units on a scale | Standard Deviation 23.9 |
| Stanmore | HOOS-Sport Subscale | 6 years postoperatively | 67.7 units on a scale | Standard Deviation 41.9 |
| Stanmore | HOOS-Sport Subscale | Pre-operatively | 27.3 units on a scale | Standard Deviation 17.5 |
| MHP Hip Stem | HOOS-Sport Subscale | 4 years postoperatively | 70.8 units on a scale | Standard Deviation 50.5 |
| MHP Hip Stem | HOOS-Sport Subscale | Pre-operatively | 26.6 units on a scale | Standard Deviation 21.8 |
| MHP Hip Stem | HOOS-Sport Subscale | 1 year postoperatively | 41.7 units on a scale | Standard Deviation 30.8 |
| MHP Hip Stem | HOOS-Sport Subscale | 7 years postoperatively | 71.9 units on a scale | Standard Deviation 39.8 |
| MHP Hip Stem | HOOS-Sport Subscale | 6 years postoperatively | 62.5 units on a scale | Standard Deviation 53 |
| MHP Hip Stem | HOOS-Sport Subscale | 10 years postoperatively | 100.0 units on a scale | — |
| MHP Hip Stem | HOOS-Sport Subscale | 2 years postoperatively | 80.0 units on a scale | Standard Deviation 30.4 |
| MHP Hip Stem | HOOS-Sport Subscale | 6 weeks postoperatively | 40.3 units on a scale | Standard Deviation 30.7 |
| MHP Hip Stem | HOOS-Sport Subscale | 5 years postoperatively | 100.0 units on a scale | — |
| MHP Hip Stem | HOOS-Sport Subscale | 3 months postoperatively | 50.0 units on a scale | Standard Deviation 33.8 |
| MHP Hip Stem | HOOS-Sport Subscale | 3 years postoperatively | 100.0 units on a scale | Standard Deviation 0 |
| MHP Hip Stem | HOOS-Sport Subscale | 6 months postoperatively | 48.3 units on a scale | Standard Deviation 37 |
Secondary
HOOS-Symptom Subscale
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.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | HOOS-Symptom Subscale | 6 months postoperatively | 76.0 units on a scale | Standard Deviation 22.8 |
| Stanmore | HOOS-Symptom Subscale | 4 years postoperatively | 85.0 units on a scale | Standard Deviation 14.4 |
| Stanmore | HOOS-Symptom Subscale | 3 years postoperatively | 84.7 units on a scale | Standard Deviation 16.4 |
| Stanmore | HOOS-Symptom Subscale | 3 months postoperatively | 68.8 units on a scale | Standard Deviation 18.5 |
| Stanmore | HOOS-Symptom Subscale | 1 year postoperatively | 89.0 units on a scale | Standard Deviation 11 |
| Stanmore | HOOS-Symptom Subscale | 5 years postoperatively | 90.8 units on a scale | Standard Deviation 9.4 |
| Stanmore | HOOS-Symptom Subscale | 6 weeks postoperatively | 74.4 units on a scale | Standard Deviation 14.4 |
| Stanmore | HOOS-Symptom Subscale | 7 years postoperatively | 90.7 units on a scale | Standard Deviation 6.7 |
| Stanmore | HOOS-Symptom Subscale | 2 years postoperatively | 85.0 units on a scale | Standard Deviation 11.5 |
| Stanmore | HOOS-Symptom Subscale | 10 years postoperatively | 82.0 units on a scale | Standard Deviation 15.2 |
| Stanmore | HOOS-Symptom Subscale | Pre-operatively | 39.5 units on a scale | Standard Deviation 16.2 |
| MHP Hip Stem | HOOS-Symptom Subscale | 10 years postoperatively | 81.7 units on a scale | Standard Deviation 16.1 |
| MHP Hip Stem | HOOS-Symptom Subscale | Pre-operatively | 57.2 units on a scale | Standard Deviation 25 |
| MHP Hip Stem | HOOS-Symptom Subscale | 6 weeks postoperatively | 63.1 units on a scale | Standard Deviation 22.7 |
| MHP Hip Stem | HOOS-Symptom Subscale | 3 months postoperatively | 70.7 units on a scale | Standard Deviation 19 |
| MHP Hip Stem | HOOS-Symptom Subscale | 6 months postoperatively | 75.0 units on a scale | Standard Deviation 16.8 |
| MHP Hip Stem | HOOS-Symptom Subscale | 1 year postoperatively | 70.7 units on a scale | Standard Deviation 31.5 |
| MHP Hip Stem | HOOS-Symptom Subscale | 2 years postoperatively | 86.7 units on a scale | Standard Deviation 14.7 |
| MHP Hip Stem | HOOS-Symptom Subscale | 3 years postoperatively | 96.7 units on a scale | Standard Deviation 5.8 |
| MHP Hip Stem | HOOS-Symptom Subscale | 4 years postoperatively | 82.5 units on a scale | Standard Deviation 25.3 |
| MHP Hip Stem | HOOS-Symptom Subscale | 5 years postoperatively | 96.7 units on a scale | Standard Deviation 5.8 |
| MHP Hip Stem | HOOS-Symptom Subscale | 7 years postoperatively | 83.8 units on a scale | Standard Deviation 20.2 |
Secondary
Number of Reported Device Related Complications
Safety: \- Frequency of serious device related complications.
Time frame: 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, 10 years postoperatively
Population: The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stanmore | Number of Reported Device Related Complications | 1 participants |
| MHP Hip Stem | Number of Reported Device Related Complications | 4 participants |
Secondary
SF-12 Mental Summary Score
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.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | SF-12 Mental Summary Score | Pre-operatively | 53.7 units on a scale | Standard Deviation 7.6 |
| Stanmore | SF-12 Mental Summary Score | 6 weeks postoperatively | 56.9 units on a scale | Standard Deviation 3.7 |
| Stanmore | SF-12 Mental Summary Score | 3 months postoperatively | 59.7 units on a scale | Standard Deviation 2.8 |
| Stanmore | SF-12 Mental Summary Score | 6 months postoperatively | 59.0 units on a scale | Standard Deviation 3.5 |
| Stanmore | SF-12 Mental Summary Score | 1 year postoperatively | 56.5 units on a scale | Standard Deviation 8.1 |
| Stanmore | SF-12 Mental Summary Score | 2 years postoperatively | 57.5 units on a scale | Standard Deviation 6.3 |
| Stanmore | SF-12 Mental Summary Score | 3 years postoperatively | 58.8 units on a scale | Standard Deviation 7.9 |
| Stanmore | SF-12 Mental Summary Score | 4 years postoperatively | 60.5 units on a scale | Standard Deviation 3 |
| Stanmore | SF-12 Mental Summary Score | 5 years postoperatively | 52.7 units on a scale | Standard Deviation 7.6 |
| Stanmore | SF-12 Mental Summary Score | 6 years postoperatively | 54.1 units on a scale | Standard Deviation 10.3 |
| Stanmore | SF-12 Mental Summary Score | 7 years postoperatively | 56.8 units on a scale | Standard Deviation 2.9 |
| Stanmore | SF-12 Mental Summary Score | 10 years postoperatively | 53.6 units on a scale | Standard Deviation 10.8 |
| MHP Hip Stem | SF-12 Mental Summary Score | 7 years postoperatively | 52.4 units on a scale | Standard Deviation 10.1 |
| MHP Hip Stem | SF-12 Mental Summary Score | Pre-operatively | 53.5 units on a scale | Standard Deviation 12.4 |
| MHP Hip Stem | SF-12 Mental Summary Score | 3 years postoperatively | 59.8 units on a scale | Standard Deviation 1.6 |
| MHP Hip Stem | SF-12 Mental Summary Score | 6 weeks postoperatively | 50.8 units on a scale | Standard Deviation 11.6 |
| MHP Hip Stem | SF-12 Mental Summary Score | 6 years postoperatively | 57.2 units on a scale | Standard Deviation 5.6 |
| MHP Hip Stem | SF-12 Mental Summary Score | 3 months postoperatively | 53.1 units on a scale | Standard Deviation 9.4 |
| MHP Hip Stem | SF-12 Mental Summary Score | 4 years postoperatively | 57.0 units on a scale | Standard Deviation 7.1 |
| MHP Hip Stem | SF-12 Mental Summary Score | 6 months postoperatively | 49.1 units on a scale | Standard Deviation 9.4 |
| MHP Hip Stem | SF-12 Mental Summary Score | 10 years postoperatively | 58.9 units on a scale | Standard Deviation 0.8 |
| MHP Hip Stem | SF-12 Mental Summary Score | 1 year postoperatively | 50.1 units on a scale | Standard Deviation 11.7 |
| MHP Hip Stem | SF-12 Mental Summary Score | 5 years postoperatively | 57.7 units on a scale | Standard Deviation 4 |
| MHP Hip Stem | SF-12 Mental Summary Score | 2 years postoperatively | 55.4 units on a scale | Standard Deviation 6.8 |
Secondary
SF-12 Physical Summary Score
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.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stanmore | SF-12 Physical Summary Score | 3 years postoperatively | 47.3 units on a scale | Standard Deviation 9.6 |
| Stanmore | SF-12 Physical Summary Score | 6 weeks postoperatively | 44.2 units on a scale | Standard Deviation 7.3 |
| Stanmore | SF-12 Physical Summary Score | 4 years postoperatively | 45.9 units on a scale | Standard Deviation 6.7 |
| Stanmore | SF-12 Physical Summary Score | 6 months postoperatively | 46.5 units on a scale | Standard Deviation 8 |
| Stanmore | SF-12 Physical Summary Score | 5 years postoperatively | 49.2 units on a scale | Standard Deviation 7.7 |
| Stanmore | SF-12 Physical Summary Score | Pre-operatively | 34.7 units on a scale | Standard Deviation 6.4 |
| Stanmore | SF-12 Physical Summary Score | 6 years postoperatively | 41.2 units on a scale | Standard Deviation 7.7 |
| Stanmore | SF-12 Physical Summary Score | 1 year postoperatively | 51.6 units on a scale | Standard Deviation 4.5 |
| Stanmore | SF-12 Physical Summary Score | 7 years postoperatively | 48.1 units on a scale | Standard Deviation 6.4 |
| Stanmore | SF-12 Physical Summary Score | 3 months postoperatively | 42.4 units on a scale | Standard Deviation 7.3 |
| Stanmore | SF-12 Physical Summary Score | 10 years postoperatively | 48.4 units on a scale | Standard Deviation 7.5 |
| Stanmore | SF-12 Physical Summary Score | 2 years postoperatively | 48.4 units on a scale | Standard Deviation 8.9 |
| MHP Hip Stem | SF-12 Physical Summary Score | 10 years postoperatively | 48.4 units on a scale | Standard Deviation 5.2 |
| MHP Hip Stem | SF-12 Physical Summary Score | Pre-operatively | 37.3 units on a scale | Standard Deviation 8.7 |
| MHP Hip Stem | SF-12 Physical Summary Score | 6 weeks postoperatively | 41.3 units on a scale | Standard Deviation 9 |
| MHP Hip Stem | SF-12 Physical Summary Score | 3 months postoperatively | 43.0 units on a scale | Standard Deviation 12.5 |
| MHP Hip Stem | SF-12 Physical Summary Score | 6 months postoperatively | 42.7 units on a scale | Standard Deviation 11 |
| MHP Hip Stem | SF-12 Physical Summary Score | 1 year postoperatively | 48.7 units on a scale | Standard Deviation 8.2 |
| MHP Hip Stem | SF-12 Physical Summary Score | 3 years postoperatively | 53.3 units on a scale | Standard Deviation 3.5 |
| MHP Hip Stem | SF-12 Physical Summary Score | 4 years postoperatively | 50.6 units on a scale | Standard Deviation 7.5 |
| MHP Hip Stem | SF-12 Physical Summary Score | 5 years postoperatively | 53.6 units on a scale | Standard Deviation 3.1 |
| MHP Hip Stem | SF-12 Physical Summary Score | 6 years postoperatively | 49.1 units on a scale | Standard Deviation 8.8 |
| MHP Hip Stem | SF-12 Physical Summary Score | 7 years postoperatively | 46.3 units on a scale | Standard Deviation 9.7 |
| MHP Hip Stem | SF-12 Physical Summary Score | 2 years postoperatively | 54.4 units on a scale | Standard Deviation 3.1 |