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A multi-centre, non-comparative, prospective post-market clinical follow-up study to obtain survival, clinical and radiographic outcomes data on the Zimmer Fitmore Hip Stem.
The objective of this post market surveillance study is to obtain outcome data on the Fitmore Hip Stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to assess the long-term performance and safety of this implant.
The Fitmore Hip Stem is a short and curved uncemented stem that allows preservation of the greater trochanter and of the gluteal muscles.
Indication/Target Population: Patients suffering from severe hip pain and disability requiring total hip arthroplasty.
Study Design: A multi-centre, non-comparative, prospective post-marketing study.
Targeted Number of Subjects: 500. Data Collection: Collection of preoperative, intra-operative and immediate post-operative data; follow-up visits at 6-12 weeks, 1, 2, 3, 5, 7 and 10 years post-operatively.
Recruitment period: 24 months. Clinical Assessments: Evaluations will be made using the Harris Hip Score, the Oxford Hip Score, the SF-12 Physical and Mental Health summary measures, the EQ-5D (EuroQol) and radiographically.
Safety Assessments: Safety will be assessed by appropriate recording and reporting of adverse events throughout the study. The Fitmore Hip Stem is CE marked, commercially available and has been pre-clinically tested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with a Fitmore Hip Stem | Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitmore Hip Stem | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score | The Harris hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care Professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). The total score can vary from a range of 0 - 100. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70. | Preop, 6 - 12 weeks, 1 year, 2 year, 3 year, 5 year, 7 and 10 years |
| Radiographic Evaluations | Radiographic evaluation was assessed at the time points listed below in order to identify potential adverse events. | 6 - 12 weeks and 7 years |
| Survivorship | The primary endpoint for this study is implant survival at 10 years which is assessed by revision of the Fitmore Hip Stem calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component. | 10 years post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| EQ5D | The EuroQol 5 Dimension (EQ-5D) is a standardized Instrument widely used to measure health status. It is a self reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, selfcare, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. The Visual Analogue Scale (VAS) is a vertical scale ranges from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her self-rated health. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering from severe hip pain and disability requiring hip surgery using the Fitmore Hip Stem, who meet all of the inclusion criteria and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Achakri | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auguste Viktoria Klinik | Bad Oeynhausen | 32545 | Germany | |||
| Universitätsklinikum Carl Gustav Carus |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Suffering From Severe Hip Pain and Disability Requiring Total Hip Arthroplasty. | Subjects in need of THA who met the inclusion/exclusion criteria and who received the Fitmore Stem |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Nov 2, 2010 |
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| Preop, 6-12 weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year |
| SF-12 Physical and Mental Functional Scores | The SF-12 is a multipurpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning. | Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year |
| Oxford Hip Score | The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (warst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The Score ranges from 0 - 100 and the outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27. | Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year |
| Dresden |
| 01307 |
| Germany |
| Clinica San Michele | Albenga | 17031 | Italy |
| Kantonsspital Graubünden | Chur | 7000 | Switzerland |
| The Yorkshire Clinic | Bingley | West Yorkshire | BD16 1TW | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Patients suffering from severe hip pain and disability requiring hip surgery or as indicated in the treatment of a fracture.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Suffering From Severe Hip Pain and Disability Requiring Total Hip Arthroplasty. | Patients suffering from severe hip pain and disability requiring hip surgery or as indicated in the treatment of a fracture. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Harris Hip Score | The Harris hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care Professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). The total score can vary from a range of 0 - 100. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70. | Study patients | Posted | Mean | Standard Deviation | score on a scale | Preop, 6 - 12 weeks, 1 year, 2 year, 3 year, 5 year, 7 and 10 years |
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| Primary | Radiographic Evaluations | Radiographic evaluation was assessed at the time points listed below in order to identify potential adverse events. | The significant radiographic findings reported for all patients during the course of the study is presented in the results section below for all follow up time points of occurrence. | Posted | Number | participants | 6 - 12 weeks and 7 years |
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| Primary | Survivorship | The primary endpoint for this study is implant survival at 10 years which is assessed by revision of the Fitmore Hip Stem calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component. | All study patients involved in the study. | Posted | Number | 95% Confidence Interval | percentage | 10 years post surgery |
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| Secondary | EQ5D | The EuroQol 5 Dimension (EQ-5D) is a standardized Instrument widely used to measure health status. It is a self reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, selfcare, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. The Visual Analogue Scale (VAS) is a vertical scale ranges from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her self-rated health. | All study patients | Posted | Mean | Standard Deviation | score on a scale | Preop, 6-12 weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year |
|
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| Secondary | SF-12 Physical and Mental Functional Scores | The SF-12 is a multipurpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning. | All study patients | Posted | Mean | Standard Deviation | score on a scale | Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year |
|
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| Secondary | Oxford Hip Score | The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (warst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The Score ranges from 0 - 100 and the outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27. | All study patients | Posted | Mean | Standard Deviation | score on a scale | Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year |
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Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
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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 | Subjects With a Fitmore Hip Stem | Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem | 30 | 420 | 40 | 420 | 132 | 420 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femoral Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | The section shows the hip related Adverse Events |
| |
| Infection | Musculoskeletal and connective tissue disorders | Systematic Assessment | Deep Infection <6 Weeks Infection, systemic sepsis Superficial Infection |
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| Other Hip Related Complication | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Deep Vein Thrombosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Heterotopic Ossification | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hematoma | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Femoral Implant Loosening | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Fracture of Femoral Shaft | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Fracture of Femoral Neck | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Fracture of Trochanter | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nerve Deficit | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Other General Complication | Musculoskeletal and connective tissue disorders | Systematic Assessment | Remaining drainage with THA |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other General Complication | Musculoskeletal and connective tissue disorders | Systematic Assessment | Coxathrosis, Depression, Dementia, Adipositas, Angiomyolipoma, |
| |
| Other General Complication | Musculoskeletal and connective tissue disorders | Systematic Assessment | Contralateral Hip or Knee |
| |
| Other Hip Related Complication | General disorders | Systematic Assessment | Cancer, Gastritis, Blood pressure,Scoliosis, Hernia, Back pain, Stent Implantation, Shingles. |
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| Other General Complications | General disorders | Systematic Assessment | Arthrosis, Pain, Osteoathritis, |
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| Other General Complications | General disorders | Systematic Assessment | Ankle Athrosis, Asthma, Diabetes. |
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| Other General Complications | General disorders | Systematic Assessment | Bronchitis, Stenosis, Shoulder problems. |
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| Other General Complication | General disorders | Systematic Assessment | Gastritis, Hernia, Back pain, Shingles, Asthma. |
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Due to the COVID 19 pandemic, many study patients could not return for the 10 year follow up resulting to drop out. In addition, one study site which enrolled 80 cases could not continue to follow the study patients at the 7 year follow up due to lack of resources to continue the study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Esther Foo | Zimmer Biomet | +41787183202 | esther.foo@zimmerbiomet.com |
| Oct 10, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011183 | Postoperative Complications |
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| >=65 years |
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| Switzerland |
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| Germany |
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| Title | Measurements |
|---|---|
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| 2 Year |
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| 3 Year |
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| 5 Year |
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| 7 Year |
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| 10 Year |
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