Avascular Necrosis, Osteoarthritis, Prosthesis Failure, Rheumatoid Arthritis
Conditions
Keywords
Total Hip Arthroplasty, Fitmore, Minimal Invasive Surgery, Short Stem
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFitmore Hip Stem
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patients who are capable of understanding the doctors explanations, following his instructions and who are able to participate in the follow-up program. * Patients who have given written consent to take part in the study by signing the Patient Consent Form. * 18 years minimum. * Male and female. * Patients suffering from severe hip pain and disability requiring hip surgery or as indicated in the treatment of a fracture.
Exclusion criteria
* Patients who are unwilling or unable to give consent or to comply with the follow-up program. * Pregnancy. * Patients who are skeletally immature.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | Preop, 6 - 12 weeks, 1 year, 2 year, 3 year, 5 year, 7 and 10 years | 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. |
| Radiographic Evaluations | 6 - 12 weeks and 7 years | Radiographic evaluation was assessed at the time points listed below in order to identify potential adverse events. |
| Survivorship | 10 years post surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ5D | Preop, 6-12 weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year | 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. |
| SF-12 Physical and Mental Functional Scores | Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year | 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. |
| Oxford Hip Score | Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year | 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. |
Countries
Germany, Italy, Switzerland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 420 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 30 |
| Overall Study | Death | 30 |
| Overall Study | Lost to Follow-up | 78 |
| Overall Study | Missing status | 4 |
| Overall Study | Withdrawal by Subject | 48 |
Baseline characteristics
| Characteristic | Patients Suffering From Severe Hip Pain and Disability Requiring Total Hip Arthroplasty. | — |
|---|---|---|
| Age, Categorical Study Population <=18 years | 0 Participants | — |
| Age, Categorical Study Population >=65 years | 0 Participants | — |
| Age, Categorical Study Population Between 18 and 65 years | 420 Participants | — |
| Age, Continuous | 62.5 Years STANDARD_DEVIATION 10.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 147 participants | — |
| Region of Enrollment Italy | 70 participants | — |
| Region of Enrollment Switzerland | 123 participants | — |
| Region of Enrollment United Kingdom | 80 participants | — |
| Sex: Female, Male Female | 190 Participants | — |
| Sex: Female, Male Male | 230 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 30 / 420 |
| other Total, other adverse events | 132 / 420 |
| serious Total, serious adverse events | 40 / 420 |
Outcome results
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.
Time frame: Preop, 6 - 12 weeks, 1 year, 2 year, 3 year, 5 year, 7 and 10 years
Population: Study patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With a Fitmore Hip Stem | Harris Hip Score | Preop | 50.0 score on a scale | Standard Deviation 17.1 |
| Subjects With a Fitmore Hip Stem | Harris Hip Score | 6 - 12 weeks | 80.6 score on a scale | Standard Deviation 14.8 |
| Subjects With a Fitmore Hip Stem | Harris Hip Score | 1 Year | 94.5 score on a scale | Standard Deviation 8 |
| Subjects With a Fitmore Hip Stem | Harris Hip Score | 2 Year | 94.5 score on a scale | Standard Deviation 9.5 |
| Subjects With a Fitmore Hip Stem | Harris Hip Score | 3 Year | 94.2 score on a scale | Standard Deviation 10 |
| Subjects With a Fitmore Hip Stem | Harris Hip Score | 5 Year | 93.5 score on a scale | Standard Deviation 11.3 |
| Subjects With a Fitmore Hip Stem | Harris Hip Score | 7 Year | 93.6 score on a scale | Standard Deviation 11.2 |
| Subjects With a Fitmore Hip Stem | Harris Hip Score | 10 Year | 92.6 score on a scale | Standard Deviation 12.1 |
Primary
Radiographic Evaluations
Radiographic evaluation was assessed at the time points listed below in order to identify potential adverse events.
Time frame: 6 - 12 weeks and 7 years
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With a Fitmore Hip Stem | Radiographic Evaluations | 6 - 12 weeks | 2 participants |
| Subjects With a Fitmore Hip Stem | Radiographic Evaluations | 7 Year | 1 participants |
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.
Time frame: 10 years post surgery
Population: All study patients involved in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects With a Fitmore Hip Stem | Survivorship | 96.85 percentage |
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.
Time frame: Preop, 6-12 weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year
Population: All study patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With a Fitmore Hip Stem | EQ5D | 10 Year EQ-5D-5L | 0.9 score on a scale | Standard Deviation 0.2 |
| Subjects With a Fitmore Hip Stem | EQ5D | Preop EQ-5D-5L | 0.4 score on a scale | Standard Deviation 0.3 |
| Subjects With a Fitmore Hip Stem | EQ5D | 6 - 12 Weeks EQ-5D-5L | 0.8 score on a scale | Standard Deviation 0.2 |
| Subjects With a Fitmore Hip Stem | EQ5D | 1 Year EQ-5D-5L | 0.9 score on a scale | Standard Deviation 0.2 |
| Subjects With a Fitmore Hip Stem | EQ5D | 2 Year EQ-5D-5L | 0.9 score on a scale | Standard Deviation 0.2 |
| Subjects With a Fitmore Hip Stem | EQ5D | 3 Year EQ-5D-5L | 0.9 score on a scale | Standard Deviation 0.2 |
| Subjects With a Fitmore Hip Stem | EQ5D | 5 Year EQ-5D-5L | 0.9 score on a scale | Standard Deviation 2 |
| Subjects With a Fitmore Hip Stem | EQ5D | 7 Year EQ-5D-5L | 0.9 score on a scale | Standard Deviation 0.2 |
| Subjects With a Fitmore Hip Stem | EQ5D | Preop VAS | 60.0 score on a scale | Standard Deviation 19 |
| Subjects With a Fitmore Hip Stem | EQ5D | 6 - 12 Weeks VAS | 74.5 score on a scale | Standard Deviation 14.6 |
| Subjects With a Fitmore Hip Stem | EQ5D | 1 Year VAS | 80.2 score on a scale | Standard Deviation 14.3 |
| Subjects With a Fitmore Hip Stem | EQ5D | 2 Year VAS | 79.1 score on a scale | Standard Deviation 16.6 |
| Subjects With a Fitmore Hip Stem | EQ5D | 3 Year VAS | 80.4 score on a scale | Standard Deviation 15.3 |
| Subjects With a Fitmore Hip Stem | EQ5D | 5 Year VAS | 80.2 score on a scale | Standard Deviation 15 |
| Subjects With a Fitmore Hip Stem | EQ5D | 10 Year VAS | 78.1 score on a scale | Standard Deviation 16.3 |
| Subjects With a Fitmore Hip Stem | EQ5D | 7 Year VAS | 79.0 score on a scale | Standard Deviation 16.2 |
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.
Time frame: Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year
Population: All study patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With a Fitmore Hip Stem | Oxford Hip Score | Preop | 19.3 score on a scale | Standard Deviation 8.1 |
| Subjects With a Fitmore Hip Stem | Oxford Hip Score | 1 Year | 42.8 score on a scale | Standard Deviation 7.4 |
| Subjects With a Fitmore Hip Stem | Oxford Hip Score | 2 Year | 43.5 score on a scale | Standard Deviation 6.8 |
| Subjects With a Fitmore Hip Stem | Oxford Hip Score | 7 Year | 44.2 score on a scale | Standard Deviation 6.4 |
| Subjects With a Fitmore Hip Stem | Oxford Hip Score | 10 Year | 43.7 score on a scale | Standard Deviation 6.3 |
| Subjects With a Fitmore Hip Stem | Oxford Hip Score | 6-12 Weeks | 36.2 score on a scale | Standard Deviation 7.5 |
| Subjects With a Fitmore Hip Stem | Oxford Hip Score | 3 Year | 43.3 score on a scale | Standard Deviation 6.8 |
| Subjects With a Fitmore Hip Stem | Oxford Hip Score | 5 Year | 43.0 score on a scale | Standard Deviation 7.5 |
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.
Time frame: Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 Year
Population: All study patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | Preop SF-12 physical | 27.1 score on a scale | Standard Deviation 9.6 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 6-12 Weeks SF-12 physical | 39.1 score on a scale | Standard Deviation 9.5 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 1 Year SF-12 physical | 49.5 score on a scale | Standard Deviation 8.6 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 2 Year SF-12 physical | 50.0 score on a scale | Standard Deviation 9.1 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 3 Year SF-12 physical | 48.9 score on a scale | Standard Deviation 9.2 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 5 Year SF-12 physical | 50.3 score on a scale | Standard Deviation 8.7 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 7 Year SF-12 physical | 49.2 score on a scale | Standard Deviation 9.3 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 10 Year SF-12 physical | 47.4 score on a scale | Standard Deviation 10.5 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | Preop SF-12 Mental | 54.2 score on a scale | Standard Deviation 9.6 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 6-12 Weeks SF-12 Mental | 56.6 score on a scale | Standard Deviation 8.1 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 1 Year SF-12 Mental | 54.7 score on a scale | Standard Deviation 7.3 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 2 Year SF-12 Mental | 55.1 score on a scale | Standard Deviation 7.7 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 3 Year SF-12 Mental | 53.7 score on a scale | Standard Deviation 8.2 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 5 Year SF-12 Mental | 53.0 score on a scale | Standard Deviation 8.1 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 7 Year SF-12 Mental | 54.2 score on a scale | Standard Deviation 8.7 |
| Subjects With a Fitmore Hip Stem | SF-12 Physical and Mental Functional Scores | 10 Year SF-12 Mental | 54.2 score on a scale | Standard Deviation 7 |