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The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stanmore | Active Comparator | 25 patients will have the Stanmore prosthesis |
|
| Metaphyseal Hip Prosthesis | Experimental | 25 patients will have the Metaphyseal Hip Prosthesis (MHP) prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metaphyseal Hip Prosthesis | Device | Metaphyseal Hip Prosthesis (MHP) hip replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months, 6 months, 1 year and 2 years postoperatively |
| RSA Translation Y | Stem movement along the y-axis in mm. (measured with RSA) | 3 months, 6 months, 1 year and 2 years postoperatively |
| RSA Translation Z | Stem movement along z-axis in mm (measured with RSA) | 3 months, 6 months, 1 year and 2 years postoperatively |
| RSA Rotation X | Stem Rotation around X-axis in degrees (measured with RSA) | 3 months, 6 months, 1 year and 2 years postoperatively |
| RSA Rotation Y | Stem rotation around the y-axis in degrees ( measured with RSA) | 3 months, 6 months, 1 year and 2 years postoperatively |
| RSA Rotation Z | Stem rotation around the z-axis in degrees (measured with RSA) | 3 months, 6 months, 1 year and 2 years postoperatively |
| RSA MTMP | Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem. | 3 months, 6 months, 1 year and 2 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Reported Device Related Complications | Safety: - Frequency of serious device related complications. | 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, 10 years postoperatively |
| Harris Hip Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stan Bell, MD | Bravis Ziekenhuis Roosendaal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bravis Ziekenhuis Roosendaal | Roosendaal | 4708 | Netherlands |
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Pre-operatively a DEXA scan was made to confirm eligibility.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stanmore | Cemented Stanmore hip stem |
| FG001 | MHP Hip Stem | Cemented MHP (Metaphyseal Hip Prosthesis) hip stem |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stanmore | Cemented Stanmore hip stem |
| BG001 | MHP Hip Stem | Cemented MHP (Metaphyseal Hip Prosthesis) hip stem |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | mm | 3 months, 6 months, 1 year and 2 years postoperatively |
|
SAE´s collected up to 10 years post/operatively
The occurrence of adverse events was assessed at each follow up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stanmore | Cemented Stanmore hip stem | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stem revision | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cortical Erosion/Osteolysis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
The enrollment was terminated early leading to a small number of patients available for analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Meijer | Zimmer Biomet | +31786292929 | linda.meijer@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2020 | Sep 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Stanmore | Device | Stanmore hip prosthesis |
|
|
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)
| pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
| 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 | 1 and 2 years postoperative |
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1,2, 3, 4, 5, 6, 7, and 10 years postoperatively |
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
| 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. | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Operative Side | Count of Participants | Participants |
|
Cemented MHP (Metaphyseal Hip Prosthesis) hip stem
|
|
| Primary | RSA Translation Y | Stem movement along the y-axis in mm. (measured with RSA) | 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. | Posted | Mean | Standard Deviation | mm | 3 months, 6 months, 1 year and 2 years postoperatively |
|
|
|
| Primary | RSA Translation Z | Stem movement along z-axis in mm (measured with RSA) | 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. | Posted | Mean | Standard Deviation | mm | 3 months, 6 months, 1 year and 2 years postoperatively |
|
|
|
| Primary | RSA Rotation X | Stem Rotation around X-axis in degrees (measured with RSA) | 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. | Posted | Mean | Standard Deviation | mm | 3 months, 6 months, 1 year and 2 years postoperatively |
|
|
|
| Primary | RSA Rotation Y | Stem rotation around the y-axis in degrees ( measured with RSA) | 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. | Posted | Mean | Standard Deviation | mm | 3 months, 6 months, 1 year and 2 years postoperatively |
|
|
|
| Primary | RSA Rotation Z | Stem rotation around the z-axis in degrees (measured with RSA) | 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. | Posted | Mean | Standard Deviation | mm | 3 months, 6 months, 1 year and 2 years postoperatively |
|
|
|
| Primary | RSA MTMP | Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem. | 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. | Posted | Mean | Standard Deviation | mm | 3 months, 6 months, 1 year and 2 years postoperatively |
|
|
|
| Secondary | Number of Reported Device Related Complications | Safety: - Frequency of serious device related complications. | The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. | Posted | Number | participants | 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, 10 years postoperatively |
|
|
|
| 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) | 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. | Posted | Mean | Standard Deviation | Scores on a scale | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | percentage of change | 1 and 2 years postoperative |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | pre-operatively, 6 weeks, 3 months, 6 months, 1,2, 3, 4, 5, 6, 7, and 10 years postoperatively |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively |
|
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|
| 11 |
| 2 |
| 11 |
| 2 |
| 11 |
| EG001 | MHP Hip Stem | Cemented MHP (Metaphyseal Hip Prosthesis) hip stem | 0 | 9 | 7 | 9 | 2 | 9 |
| Cardiac Disorder | Cardiac disorders | Non-systematic Assessment | ST depression and Myocard Infarction |
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| Cup revision | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in groin During Weigth Bearing | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Superficial Infection Wound | Infections and infestations | Non-systematic Assessment |
|
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