Trial Outcomes & Findings for Fitmore Hip Stem PMCF Study: A Multi-centre, Non-comparative, Prospective Post-market Clinical Follow-up Study. (NCT NCT03411044)
NCT ID: NCT03411044
Last Updated: 2024-11-05
Results Overview
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.
COMPLETED
420 participants
Preop, 6 - 12 weeks, 1 year, 2 year, 3 year, 5 year, 7 and 10 years
2024-11-05
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
420
|
|
Overall Study
COMPLETED
|
230
|
|
Overall Study
NOT COMPLETED
|
190
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Death
|
30
|
|
Overall Study
Withdrawal by Subject
|
48
|
|
Overall Study
Lost to Follow-up
|
78
|
|
Overall Study
Adverse Event
|
30
|
|
Overall Study
Missing status
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients Suffering From Severe Hip Pain and Disability Requiring Total Hip Arthroplasty.
n=420 Participants
Patients suffering from severe hip pain and disability requiring hip surgery or as indicated in the treatment of a fracture.
|
|---|---|
|
Age, Categorical
Study Population · <=18 years
|
0 Participants
n=420 Participants
|
|
Age, Categorical
Study Population · Between 18 and 65 years
|
420 Participants
n=420 Participants
|
|
Age, Categorical
Study Population · >=65 years
|
0 Participants
n=420 Participants
|
|
Age, Continuous
|
62.5 Years
STANDARD_DEVIATION 10.7 • n=420 Participants
|
|
Sex: Female, Male
Female
|
190 Participants
n=420 Participants
|
|
Sex: Female, Male
Male
|
230 Participants
n=420 Participants
|
|
Region of Enrollment
Italy
|
70 participants
n=420 Participants
|
|
Region of Enrollment
United Kingdom
|
80 participants
n=420 Participants
|
|
Region of Enrollment
Switzerland
|
123 participants
n=420 Participants
|
|
Region of Enrollment
Germany
|
147 participants
n=420 Participants
|
PRIMARY outcome
Timeframe: Preop, 6 - 12 weeks, 1 year, 2 year, 3 year, 5 year, 7 and 10 yearsPopulation: Study patients
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.
Outcome measures
| Measure |
Subjects With a Fitmore Hip Stem
n=358 Participants
Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem.
|
|---|---|
|
Harris Hip Score
10 Year
|
92.6 score on a scale
Standard Deviation 12.1
|
|
Harris Hip Score
Preop
|
50.0 score on a scale
Standard Deviation 17.1
|
|
Harris Hip Score
6 - 12 weeks
|
80.6 score on a scale
Standard Deviation 14.8
|
|
Harris Hip Score
1 Year
|
94.5 score on a scale
Standard Deviation 8.0
|
|
Harris Hip Score
2 Year
|
94.5 score on a scale
Standard Deviation 9.5
|
|
Harris Hip Score
3 Year
|
94.2 score on a scale
Standard Deviation 10.0
|
|
Harris Hip Score
5 Year
|
93.5 score on a scale
Standard Deviation 11.3
|
|
Harris Hip Score
7 Year
|
93.6 score on a scale
Standard Deviation 11.2
|
PRIMARY outcome
Timeframe: 6 - 12 weeks and 7 yearsPopulation: 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.
Radiographic evaluation was assessed at the time points listed below in order to identify potential adverse events.
Outcome measures
| Measure |
Subjects With a Fitmore Hip Stem
n=164 Participants
Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem.
|
|---|---|
|
Radiographic Evaluations
6 - 12 weeks
|
2 participants
|
|
Radiographic Evaluations
7 Year
|
1 participants
|
PRIMARY outcome
Timeframe: 10 years post surgeryPopulation: All study patients involved in the study.
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.
Outcome measures
| Measure |
Subjects With a Fitmore Hip Stem
n=420 Participants
Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem.
|
|---|---|
|
Survivorship
|
96.85 percentage
Interval 94.14 to 98.32
|
SECONDARY outcome
Timeframe: Preop, 6-12 weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 YearPopulation: All study patients
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.
Outcome measures
| Measure |
Subjects With a Fitmore Hip Stem
n=314 Participants
Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem.
|
|---|---|
|
EQ5D
7 Year EQ-5D-5L
|
0.9 score on a scale
Standard Deviation 0.2
|
|
EQ5D
Preop EQ-5D-5L
|
0.4 score on a scale
Standard Deviation 0.3
|
|
EQ5D
2 Year EQ-5D-5L
|
0.9 score on a scale
Standard Deviation 0.2
|
|
EQ5D
3 Year EQ-5D-5L
|
0.9 score on a scale
Standard Deviation 0.2
|
|
EQ5D
5 Year EQ-5D-5L
|
0.9 score on a scale
Standard Deviation 02
|
|
EQ5D
10 Year EQ-5D-5L
|
0.9 score on a scale
Standard Deviation 0.2
|
|
EQ5D
Preop VAS
|
60.0 score on a scale
Standard Deviation 19.0
|
|
EQ5D
6 - 12 Weeks VAS
|
74.5 score on a scale
Standard Deviation 14.6
|
|
EQ5D
1 Year VAS
|
80.2 score on a scale
Standard Deviation 14.3
|
|
EQ5D
2 Year VAS
|
79.1 score on a scale
Standard Deviation 16.6
|
|
EQ5D
3 Year VAS
|
80.4 score on a scale
Standard Deviation 15.3
|
|
EQ5D
7 Year VAS
|
79.0 score on a scale
Standard Deviation 16.2
|
|
EQ5D
10 Year VAS
|
78.1 score on a scale
Standard Deviation 16.3
|
|
EQ5D
6 - 12 Weeks EQ-5D-5L
|
0.8 score on a scale
Standard Deviation 0.2
|
|
EQ5D
1 Year EQ-5D-5L
|
0.9 score on a scale
Standard Deviation 0.2
|
|
EQ5D
5 Year VAS
|
80.2 score on a scale
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 YearPopulation: All study patients
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.
Outcome measures
| Measure |
Subjects With a Fitmore Hip Stem
n=297 Participants
Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the 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
|
|
SF-12 Physical and Mental Functional Scores
1 Year SF-12 Mental
|
54.7 score on a scale
Standard Deviation 7.3
|
|
SF-12 Physical and Mental Functional Scores
2 Year SF-12 Mental
|
55.1 score on a scale
Standard Deviation 7.7
|
|
SF-12 Physical and Mental Functional Scores
3 Year SF-12 Mental
|
53.7 score on a scale
Standard Deviation 8.2
|
|
SF-12 Physical and Mental Functional Scores
Preop SF-12 physical
|
27.1 score on a scale
Standard Deviation 9.6
|
|
SF-12 Physical and Mental Functional Scores
6-12 Weeks SF-12 physical
|
39.1 score on a scale
Standard Deviation 9.5
|
|
SF-12 Physical and Mental Functional Scores
1 Year SF-12 physical
|
49.5 score on a scale
Standard Deviation 8.6
|
|
SF-12 Physical and Mental Functional Scores
2 Year SF-12 physical
|
50.0 score on a scale
Standard Deviation 9.1
|
|
SF-12 Physical and Mental Functional Scores
3 Year SF-12 physical
|
48.9 score on a scale
Standard Deviation 9.2
|
|
SF-12 Physical and Mental Functional Scores
5 Year SF-12 physical
|
50.3 score on a scale
Standard Deviation 8.7
|
|
SF-12 Physical and Mental Functional Scores
7 Year SF-12 physical
|
49.2 score on a scale
Standard Deviation 9.3
|
|
SF-12 Physical and Mental Functional Scores
Preop SF-12 Mental
|
54.2 score on a scale
Standard Deviation 9.6
|
|
SF-12 Physical and Mental Functional Scores
6-12 Weeks SF-12 Mental
|
56.6 score on a scale
Standard Deviation 8.1
|
|
SF-12 Physical and Mental Functional Scores
5 Year SF-12 Mental
|
53.0 score on a scale
Standard Deviation 8.1
|
|
SF-12 Physical and Mental Functional Scores
7 Year SF-12 Mental
|
54.2 score on a scale
Standard Deviation 8.7
|
|
SF-12 Physical and Mental Functional Scores
10 Year SF-12 Mental
|
54.2 score on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Preop, 6-12 Weeks, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year and 10 YearPopulation: All study patients
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.
Outcome measures
| Measure |
Subjects With a Fitmore Hip Stem
n=329 Participants
Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem.
|
|---|---|
|
Oxford Hip Score
6-12 Weeks
|
36.2 score on a scale
Standard Deviation 7.5
|
|
Oxford Hip Score
1 Year
|
42.8 score on a scale
Standard Deviation 7.4
|
|
Oxford Hip Score
2 Year
|
43.5 score on a scale
Standard Deviation 6.8
|
|
Oxford Hip Score
Preop
|
19.3 score on a scale
Standard Deviation 8.1
|
|
Oxford Hip Score
3 Year
|
43.3 score on a scale
Standard Deviation 6.8
|
|
Oxford Hip Score
5 Year
|
43.0 score on a scale
Standard Deviation 7.5
|
|
Oxford Hip Score
7 Year
|
44.2 score on a scale
Standard Deviation 6.4
|
|
Oxford Hip Score
10 Year
|
43.7 score on a scale
Standard Deviation 6.3
|
Adverse Events
Subjects With a Fitmore Hip Stem
Serious adverse events
| Measure |
Subjects With a Fitmore Hip Stem
n=420 participants at risk
Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Femoral Pain
|
2.1%
9/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
Musculoskeletal and connective tissue disorders
Infection
|
1.9%
8/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
Musculoskeletal and connective tissue disorders
Other Hip Related Complication
|
1.4%
6/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
Musculoskeletal and connective tissue disorders
Deep Vein Thrombosis
|
0.71%
3/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
Musculoskeletal and connective tissue disorders
Heterotopic Ossification
|
0.95%
4/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
Musculoskeletal and connective tissue disorders
Hematoma
|
0.71%
3/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
Musculoskeletal and connective tissue disorders
Femoral Implant Loosening
|
0.48%
2/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
Musculoskeletal and connective tissue disorders
Fracture of Femoral Shaft
|
0.48%
2/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
Musculoskeletal and connective tissue disorders
Fracture of Femoral Neck
|
0.48%
2/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
Musculoskeletal and connective tissue disorders
Fracture of Trochanter
|
0.48%
2/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
Musculoskeletal and connective tissue disorders
Nerve Deficit
|
0.24%
1/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
Musculoskeletal and connective tissue disorders
Other General Complication
|
0.48%
2/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
Other adverse events
| Measure |
Subjects With a Fitmore Hip Stem
n=420 participants at risk
Subjects in need of a total hip arthroplasty who met the inclusion/exclusion criteria and who received the Fitmore Hip Stem
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Other General Complication
|
4.5%
19/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
General disorders
Other Hip Related Complication
|
4.5%
19/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
General disorders
Other General Complications
|
4.5%
19/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
|
General disorders
Other General Complication
|
4.3%
18/420 • Operative, 6-12 weeks, 1, 2, 3, 5, 7, 10 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place