Trial Outcomes & Findings for Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component (NCT NCT03681639)
NCT ID: NCT03681639
Last Updated: 2024-12-03
Results Overview
The primary endpoint for this study is implant survival at 10 years which is assessed by revision of the Metasul Monoblock Component Cup 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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
10 years post-surgery
Results posted on
2024-12-03
Participant Flow
Participant milestones
| Measure |
Patients Who Received Metasul Monoblock in Hip Resurfacing
Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component™ Cup in a Hip Resurfacing Application with the Durom® Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured.
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul® LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
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|---|---|
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Overall Study
STARTED
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45
|
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Overall Study
COMPLETED
|
36
|
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Overall Study
NOT COMPLETED
|
9
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Reasons for withdrawal
| Measure |
Patients Who Received Metasul Monoblock in Hip Resurfacing
Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component™ Cup in a Hip Resurfacing Application with the Durom® Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured.
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul® LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
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|---|---|
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Overall Study
Death
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients Who Received the Zimmer Hip Resurfacing System
n=45 Participants
The Zimmer Hip Resurfacing System is designed for the treatment of degenerative diseases or trauma of the hip. The system is intended to reduce pain and increase hip mobility.
The Zimmer Hip Resurfacing System may be used for the following indications:
* Non inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, primary osteoarthritis and post traumatic arthritis
* Inflammatory joint disease (IJD), e.g. rheumatoid arthritis.
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|---|---|
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Age, Continuous
Age
|
50.9 Years
STANDARD_DEVIATION 7.7 • n=45 Participants
|
|
Sex: Female, Male
Female
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1 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=45 Participants
|
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Region of Enrollment
Germany
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45 Participants
n=45 Participants
|
|
Body Mass Index (BMI)
|
28.6 kg/m^2
STANDARD_DEVIATION 3.9 • n=45 Participants
|
|
Weight
|
90.7 Kg
STANDARD_DEVIATION 13.0 • n=45 Participants
|
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Height
|
178.2 Cm
STANDARD_DEVIATION 7.2 • n=45 Participants
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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 Metasul Monoblock Component Cup 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 |
Patients Who Received Metasul Monoblock in Hip Resurfacing
n=45 Participants
Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component Cup in a Hip Resurfacing Application with the Durom Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured.
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
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|---|---|
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Implant Survival
|
95.39 percentage of participants
Interval 82.79 to 98.83
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SECONDARY outcome
Timeframe: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgeryPopulation: The mean Harris Hip Score and standard deviation for all study patients is presented in the results section below for all follow up time points.
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, function and functional activities, absence of deformity and range of motion. The total score 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 |
Patients Who Received Metasul Monoblock in Hip Resurfacing
n=45 Participants
Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component Cup in a Hip Resurfacing Application with the Durom Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured.
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
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|---|---|
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Harris Hip Score
Preop
|
55.1 score on a scale
Standard Deviation 8.2
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Harris Hip Score
6 Months
|
93.9 score on a scale
Standard Deviation 7.4
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Harris Hip Score
1 Year
|
95.3 score on a scale
Standard Deviation 7.3
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Harris Hip Score
2 Year
|
97.3 score on a scale
Standard Deviation 5.3
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Harris Hip Score
3 Year
|
96.6 score on a scale
Standard Deviation 10.5
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Harris Hip Score
5 Year
|
98.6 score on a scale
Standard Deviation 3.2
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|
Harris Hip Score
7 Year
|
98.1 score on a scale
Standard Deviation 4.1
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|
Harris Hip Score
10 Year
|
97.2 score on a scale
Standard Deviation 5.2
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SECONDARY outcome
Timeframe: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgeryPopulation: The mean and standard deviation for SF-12 physical and mental is presented in the results section below for all follow up time points.
The SF-12 is a multi-purpose 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 |
Patients Who Received Metasul Monoblock in Hip Resurfacing
n=45 Participants
Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component Cup in a Hip Resurfacing Application with the Durom Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured.
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
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|---|---|
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
7 Year Mental Health SF12 Score
|
55.5 score on a scale
Standard Deviation 5.6
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
5 Year Mental Health SF12 Score
|
56.1 score on a scale
Standard Deviation 5.5
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
Preop Mental Health SF12 Score
|
49.7 score on a scale
Standard Deviation 10.7
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
6 Months Mental Health SF12 Score
|
54.3 score on a scale
Standard Deviation 8.9
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
1 Year Mental Health SF12 Score
|
55.1 score on a scale
Standard Deviation 6.1
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
2 Year Mental Health SF12 Score
|
55.1 score on a scale
Standard Deviation 6.8
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
3 Year Mental Health SF12 Score
|
53.9 score on a scale
Standard Deviation 7.8
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
10 Year Mental Health SF12 Score SF12 Score
|
54.6 score on a scale
Standard Deviation 7.7
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
Preop Physical Health SF12 Score SF12 Score
|
30.5 score on a scale
Standard Deviation 8.8
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
6 Month Physical Health SF12 Score
|
47.8 score on a scale
Standard Deviation 7.7
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
1 Year Physical Health SF12 Score
|
49.1 score on a scale
Standard Deviation 9.7
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
2 Year Physical Health SF12 Score
|
50.2 score on a scale
Standard Deviation 9.2
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
3 Year Physical Health SF12 Score
|
49.2 score on a scale
Standard Deviation 10.0
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
5 Year Physical Health SF12 Score
|
50.6 score on a scale
Standard Deviation 7.7
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Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
7 Year Physical Health SF12 Score
|
50.8 score on a scale
Standard Deviation 6.8
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|
Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health)
10 Year Physical Health SF12 Score
|
48.7 score on a scale
Standard Deviation 9.0
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SECONDARY outcome
Timeframe: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgeryPopulation: The mean and standard deviation for UCLA activity score is presented in the results section below for all follow up time points.
The UCLA score was a part of the Patient Activity Questionnaire which ascertains the patient's activity level from 1 (low) to 10 (high) in patients undergoing total hip arthroplasty.
Outcome measures
| Measure |
Patients Who Received Metasul Monoblock in Hip Resurfacing
n=45 Participants
Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component Cup in a Hip Resurfacing Application with the Durom Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured.
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
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|---|---|
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Patient's Activity Level Determined by UCLA Score
Preop
|
4.9 score on a scale
Standard Deviation 2.1
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Patient's Activity Level Determined by UCLA Score
6 Month
|
6.5 score on a scale
Standard Deviation 1.7
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Patient's Activity Level Determined by UCLA Score
1 Year
|
6.4 score on a scale
Standard Deviation 1.9
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Patient's Activity Level Determined by UCLA Score
2 Year
|
6.8 score on a scale
Standard Deviation 1.9
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Patient's Activity Level Determined by UCLA Score
3 Year
|
6.9 score on a scale
Standard Deviation 2.1
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|
Patient's Activity Level Determined by UCLA Score
5 Year
|
7.0 score on a scale
Standard Deviation 1.7
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|
Patient's Activity Level Determined by UCLA Score
7 Year
|
6.7 score on a scale
Standard Deviation 2.0
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|
Patient's Activity Level Determined by UCLA Score
10 Year
|
6.6 score on a scale
Standard Deviation 1.9
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SECONDARY outcome
Timeframe: Pre-op, 6 weeks, 1,2,3,5,7 and 10 years post operatively 2, 3, 5, 7 and 10 years post-operatively. 2, 3, 5, 7 and 10 years post-operatively.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.
Radiographic parameters evaluated were radiolucencies, osteolysis, hypertrophy, subsidence, cup migration, change in cup angle and change in femoral shaft angle. The radiographs related to any significant radiographic findings reported by an Investigator were also be assessed by an Independent Radiographic Reviewer. The data presented in the outcome measure data table represent the Number of Participants with Abnormal or Significant Findings during the course of the study.
Outcome measures
| Measure |
Patients Who Received Metasul Monoblock in Hip Resurfacing
n=45 Participants
Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component Cup in a Hip Resurfacing Application with the Durom Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured.
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
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|---|---|
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Radiographic Evaluation
7 Years Osteolysis
|
1 participants
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Radiographic Evaluation
6 Month Stem Radiolucency
|
1 participants
|
SECONDARY outcome
Timeframe: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgeryPopulation: The mean and standard deviation for EQ-5D is presented in the results section below for all follow up time points.
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. For this study, the VAS score was not calculated.
Outcome measures
| Measure |
Patients Who Received Metasul Monoblock in Hip Resurfacing
n=45 Participants
Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component Cup in a Hip Resurfacing Application with the Durom Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured.
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
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|---|---|
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EuroQol 5 Dimension (EQ-5D)
PreOp
|
0.5 score on a scale
Standard Deviation 0.2
|
|
EuroQol 5 Dimension (EQ-5D)
6 Month
|
0.8 score on a scale
Standard Deviation 0.2
|
|
EuroQol 5 Dimension (EQ-5D)
1 Year
|
0.9 score on a scale
Standard Deviation 0.1
|
|
EuroQol 5 Dimension (EQ-5D)
2 Year
|
0.9 score on a scale
Standard Deviation 0.2
|
|
EuroQol 5 Dimension (EQ-5D)
3 Year
|
0.9 score on a scale
Standard Deviation 0.2
|
|
EuroQol 5 Dimension (EQ-5D)
5 Year
|
0.9 score on a scale
Standard Deviation 0.1
|
|
EuroQol 5 Dimension (EQ-5D)
7 Year
|
0.9 score on a scale
Standard Deviation 0.2
|
|
EuroQol 5 Dimension (EQ-5D)
10 Year
|
0.8 score on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgeryPopulation: The mean and standard deviation for Oxford Hip Score is presented in the results section below for all follow up time points.
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 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. Scores ranges from 0 to 100 and the outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27.
Outcome measures
| Measure |
Patients Who Received Metasul Monoblock in Hip Resurfacing
n=45 Participants
Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component Cup in a Hip Resurfacing Application with the Durom Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured.
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
|
|---|---|
|
Oxford Hip Score
Preop
|
21.7 score on a scale
Standard Deviation 6.8
|
|
Oxford Hip Score
6 Month
|
35.3 score on a scale
Standard Deviation 12.3
|
|
Oxford Hip Score
1 Year
|
39.1 score on a scale
Standard Deviation 11.8
|
|
Oxford Hip Score
2 Year
|
44.0 score on a scale
Standard Deviation 7.2
|
|
Oxford Hip Score
3 Year
|
44.6 score on a scale
Standard Deviation 6.5
|
|
Oxford Hip Score
5 Year
|
44.7 score on a scale
Standard Deviation 5.6
|
|
Oxford Hip Score
7 Year
|
45.8 score on a scale
Standard Deviation 3.6
|
|
Oxford Hip Score
10 Year
|
44.9 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgeryPopulation: The mean and standard deviation for the WOMAC pain and physical function score is presented in the results section below for all follow up time points. The number of participants analyzed is not consistent with the numbers in the participant flow module because the numbers reported in the participant flow module represents the number of patients with these form completed at the subsequent follow up time points.
The WOMAC Score is a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip. These set of standardized questions are used by doctors to evaluate the condition of osteoarthritis patients. The WOMAC score was an optional form reported for pain and physical function. The test questions are scored on a scale of 0-4, which correspond to: No pain (0), Mild pain (1), Moderate pain (2), Severe pain (3), and Extreme pain (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain (with higher values representing worse outcomes and lower values representing better outcomes) and 0-68 for Physical Function (with higher values representing better outcomes and lower values representing worse outcomes).
Outcome measures
| Measure |
Patients Who Received Metasul Monoblock in Hip Resurfacing
n=44 Participants
Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component Cup in a Hip Resurfacing Application with the Durom Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured.
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
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|---|---|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Preop WOMAC Pain Score
|
9.8 score on a scale
Standard Deviation 2.8
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
6 Month WOMAC Pain Score
|
1.8 score on a scale
Standard Deviation 2.8
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
1 Year WOMAC Pain Score
|
1.4 score on a scale
Standard Deviation 2.5
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
2 Year WOMAC Pain Score
|
1.0 score on a scale
Standard Deviation 2.1
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
3 Year WOMAC Pain Score
|
1.1 score on a scale
Standard Deviation 2.2
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
5 Year WOMAC Pain Score
|
1.1 score on a scale
Standard Deviation 2.3
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
7 Year WOMAC Pain Score
|
0.6 score on a scale
Standard Deviation 1.1
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
10 Year WOMAC Pain Score
|
1.1 score on a scale
Standard Deviation 2.1
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Preop WOMAC Physical Function Score
|
33.4 score on a scale
Standard Deviation 11.1
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
6 Month WOMAC Physical Function Score
|
8.2 score on a scale
Standard Deviation 10.7
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
1 Year WOMAC Physical Function Score
|
5.9 score on a scale
Standard Deviation 8.7
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
2 Year WOMAC Physical Function Score
|
3.8 score on a scale
Standard Deviation 7.2
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
3 Year WOMAC Physical Function Score
|
5.1 score on a scale
Standard Deviation 8.3
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
5 Year WOMAC Physical Function Score
|
4.7 score on a scale
Standard Deviation 8.3
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
7 Year WOMAC Physical Function Score
|
4.1 score on a scale
Standard Deviation 7.3
|
|
Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
10 Year WOMAC Physical Function Score
|
5.7 score on a scale
Standard Deviation 8.1
|
Adverse Events
Patients Who Received Metasul Monoblock in Hip Resurfacing
Serious events: 3 serious events
Other events: 17 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Patients Who Received Metasul Monoblock in Hip Resurfacing
n=45 participants at risk
Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component Cup in a Hip Resurfacing Application with the Durom Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured.
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Femoral Neck Fracture
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Musculoskeletal and connective tissue disorders
Translucency
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
Other adverse events
| Measure |
Patients Who Received Metasul Monoblock in Hip Resurfacing
n=45 participants at risk
Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component Cup in a Hip Resurfacing Application with the Durom Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured.
Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
|
|---|---|
|
Cardiac disorders
Cardiovascular
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Endocrine disorders
Endocrine
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
General disorders
Hematological
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscoloskeletal
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Respiratory
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Musculoskeletal and connective tissue disorders
Thigh Groin Hip Pain
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
General disorders
Other General Complications
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Surgical and medical procedures
Other General Complications
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Gastrointestinal disorders
Other General Complications
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Reproductive system and breast disorders
Other General Complications
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Social circumstances
Other General Complications
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Skin and subcutaneous tissue disorders
Other General Complications
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
2.2%
1/45 • Number of events 1 • Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place