An observational study in Osteoarthritis, Avascular Necrosis and Rheumatoid Arthritis, sponsored by Zimmer Biomet. Completed at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by Zimmer Biomet · Observational
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.
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.
Exclusion Criteria:
Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem.
Device: Fitmore Hip Stem
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
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
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
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
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
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
| Milestone | Patients Suffering From Severe Hip Pain and Disability Requiring Total Hip Arthroplasty. |
|---|---|
| Started | 420 |
| Completed | 230 |
| Not completed | 190 |
| Withdrew: Death | 30 |
| Withdrew: Withdrawal by subject | 48 |
| Withdrew: Lost to follow-up | 78 |
| Withdrew: Adverse event | 30 |
| Withdrew: Missing status | 4 |
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.
| score on a scale | Subjects With a Fitmore Hip Stem |
|---|---|
| Preop | 50.0 ± 17.1 |
| 6 - 12 weeks | 80.6 ± 14.8 |
| 1 Year | 94.5 ± 8.0 |
| 2 Year | 94.5 ± 9.5 |
| 3 Year | 94.2 ± 10.0 |
| 5 Year | 93.5 ± 11.3 |
| 7 Year | 93.6 ± 11.2 |
| 10 Year | 92.6 ± 12.1 |
Radiographic evaluation was assessed at the time points listed below in order to identify potential adverse events.
| participants | Subjects With a Fitmore Hip Stem |
|---|---|
| 6 - 12 weeks | 2 |
| 7 Year | 1 |
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.
| percentage | Subjects With a Fitmore Hip Stem |
|---|---|
| Survivorship | 96.85 (94.14 to 98.32) |
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.
| score on a scale | Subjects With a Fitmore Hip Stem |
|---|---|
| Preop EQ-5D-5L | 0.4 ± 0.3 |
| 6 - 12 Weeks EQ-5D-5L | 0.8 ± 0.2 |
| 1 Year EQ-5D-5L | 0.9 ± 0.2 |
| 2 Year EQ-5D-5L | 0.9 ± 0.2 |
| 3 Year EQ-5D-5L | 0.9 ± 0.2 |
| 5 Year EQ-5D-5L | 0.9 ± 02 |
| 7 Year EQ-5D-5L | 0.9 ± 0.2 |
| 10 Year EQ-5D-5L | 0.9 ± 0.2 |
| Preop VAS | 60.0 ± 19.0 |
| 6 - 12 Weeks VAS | 74.5 ± 14.6 |
| 1 Year VAS | 80.2 ± 14.3 |
| 2 Year VAS | 79.1 ± 16.6 |
| 3 Year VAS | 80.4 ± 15.3 |
| 5 Year VAS | 80.2 ± 15.0 |
| 7 Year VAS | 79.0 ± 16.2 |
| 10 Year VAS | 78.1 ± 16.3 |
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.
| score on a scale | Subjects With a Fitmore Hip Stem |
|---|---|
| Preop SF-12 physical | 27.1 ± 9.6 |
| 6-12 Weeks SF-12 physical | 39.1 ± 9.5 |
| 1 Year SF-12 physical | 49.5 ± 8.6 |
| 2 Year SF-12 physical | 50.0 ± 9.1 |
| 3 Year SF-12 physical | 48.9 ± 9.2 |
| 5 Year SF-12 physical | 50.3 ± 8.7 |
| 7 Year SF-12 physical | 49.2 ± 9.3 |
| 10 Year SF-12 physical | 47.4 ± 10.5 |
| Preop SF-12 Mental | 54.2 ± 9.6 |
| 6-12 Weeks SF-12 Mental | 56.6 ± 8.1 |
| 1 Year SF-12 Mental | 54.7 ± 7.3 |
| 2 Year SF-12 Mental | 55.1 ± 7.7 |
| 3 Year SF-12 Mental | 53.7 ± 8.2 |
| 5 Year SF-12 Mental | 53.0 ± 8.1 |
| 7 Year SF-12 Mental | 54.2 ± 8.7 |
| 10 Year SF-12 Mental | 54.2 ± 7.0 |
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.
| score on a scale | Subjects With a Fitmore Hip Stem |
|---|---|
| Preop | 19.3 ± 8.1 |
| 6-12 Weeks | 36.2 ± 7.5 |
| 1 Year | 42.8 ± 7.4 |
| 2 Year | 43.5 ± 6.8 |
| 3 Year | 43.3 ± 6.8 |
| 5 Year | 43.0 ± 7.5 |
| 7 Year | 44.2 ± 6.4 |
| 10 Year | 43.7 ± 6.3 |
Collected over Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects With a Fitmore Hip Stem | 30/420 (7.1%) | 40/420 (9.5%) | 132/420 (31.4%) |
| Event | Subjects With a Fitmore Hip Stem |
|---|---|
| Femoral PainMusculoskeletal and connective tissue disorders | 9/420 |
| InfectionMusculoskeletal and connective tissue disorders | 8/420 |
| Other Hip Related ComplicationMusculoskeletal and connective tissue disorders | 6/420 |
| Heterotopic OssificationMusculoskeletal and connective tissue disorders | 4/420 |
| Deep Vein ThrombosisMusculoskeletal and connective tissue disorders | 3/420 |
| HematomaMusculoskeletal and connective tissue disorders | 3/420 |
| Femoral Implant LooseningMusculoskeletal and connective tissue disorders | 2/420 |
| Fracture of Femoral ShaftMusculoskeletal and connective tissue disorders | 2/420 |
| Fracture of Femoral NeckMusculoskeletal and connective tissue disorders | 2/420 |
| Fracture of TrochanterMusculoskeletal and connective tissue disorders | 2/420 |
| Event | Subjects With a Fitmore Hip Stem |
|---|---|
| Other General ComplicationMusculoskeletal and connective tissue disorders | 19/420 |
| Other General ComplicationMusculoskeletal and connective tissue disorders | 19/420 |
| Other Hip Related ComplicationGeneral disorders | 19/420 |
| Other General ComplicationsGeneral disorders | 19/420 |
| Other General ComplicationsGeneral disorders | 19/420 |
| Other General ComplicationsGeneral disorders | 19/420 |
| Other General ComplicationGeneral disorders | 18/420 |
Patients suffering from severe hip pain and disability requiring hip surgery or as indicated in the treatment of a fracture.
| Age, Categorical(Participants) | Patients Suffering From Severe Hip Pain and Disability Requiring Total Hip Arthroplasty. |
|---|---|
| Study Population — <=18 years | 0 |
| Study Population — Between 18 and 65 years | 420 |
| Study Population — >=65 years | 0 |
| Age, Continuous(Years) | Patients Suffering From Severe Hip Pain and Disability Requiring Total Hip Arthroplasty. |
|---|---|
| Mean | 62.5 ± 10.7 |
| Sex: Female, Male(Participants) | Patients Suffering From Severe Hip Pain and Disability Requiring Total Hip Arthroplasty. |
|---|---|
| Female | 190 |
| Male | 230 |
| Race and Ethnicity Not Collected(Participants) | Patients Suffering From Severe Hip Pain and Disability Requiring Total Hip Arthroplasty. |
|---|
| Region of Enrollment(participants) | Patients Suffering From Severe Hip Pain and Disability Requiring Total Hip Arthroplasty. |
|---|---|
| Italy | 70 |
| United Kingdom | 80 |
| Switzerland | 123 |
| Germany | 147 |
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