Trial Outcomes & Findings for Continuum™ Metal Bearing System in Total Hip Arthroplasty (NCT NCT03382652)
NCT ID: NCT03382652
Last Updated: 2025-01-03
Results Overview
The primary endpoint for this study is implant survival at 10 years which was assessed by revision either of the Continuum Cup or the Metasul liner. A success rate for the experimental group was calculated using the Kaplan-Meier Survival Estimation.
Recruitment status
COMPLETED
Target enrollment
83 participants
Primary outcome timeframe
1, 2, 3, 5, 7, and 10 years postop.
Results posted on
2025-01-03
Participant Flow
Participant milestones
| Measure |
Subjects Who Received the Continuum Metal on Metal System
Patients requiring total hip arthroplasty, who met the inclusion/exclusion criteria and received the Continuum Metal on Metal System
|
|---|---|
|
Overall Study
STARTED
|
83
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
| Measure |
Subjects Who Received the Continuum Metal on Metal System
Patients requiring total hip arthroplasty, who met the inclusion/exclusion criteria and received the Continuum Metal on Metal System
|
|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Death
|
4
|
|
Overall Study
Revision
|
5
|
|
Overall Study
Patient withdrew
|
3
|
|
Overall Study
Other reasons
|
21
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients Who Received the Continuum Metal on Metal System
n=83 Participants
Patients required total hip arthroplasty, who met the inclusion/exclusion criteria and received the Continuum Metal on Metal System
|
|---|---|
|
Age, Continuous
|
57.7 years
n=83 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=83 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=83 Participants
|
|
Region of Enrollment
Finland
|
57 participants
n=83 Participants
|
|
BMI
|
28.6 kg/m²
n=83 Participants
|
|
Diagnosis
Osteoarthritis
|
74 participants
n=83 Participants
|
|
Diagnosis
Avascular Necrosis
|
7 participants
n=83 Participants
|
|
Diagnosis
Rheumatoid Arthritis
|
2 participants
n=83 Participants
|
PRIMARY outcome
Timeframe: 1, 2, 3, 5, 7, and 10 years postop.Population: All study patients
The primary endpoint for this study is implant survival at 10 years which was assessed by revision either of the Continuum Cup or the Metasul liner. A success rate for the experimental group was calculated using the Kaplan-Meier Survival Estimation.
Outcome measures
| Measure |
Patients Who Received the Continuum Metal on Metal System
n=83 Participants
Patients requiring total hip arthroplasty, who met the inclusion/exclusion criteria and received the Continuum Metal on Metal System
|
|---|---|
|
Implant Survival at 10 Years
1-year Kaplan Meier Survival Estimate
|
98.8 percentage of participants
Interval 91.75 to 99.83
|
|
Implant Survival at 10 Years
2-year Kaplan Meier Survival Estimate
|
97.5 percentage of participants
Interval 90.34 to 99.37
|
|
Implant Survival at 10 Years
3-year Kaplan Meier Survival Estimate
|
96.16 percentage of participants
Interval 88.55 to 98.75
|
|
Implant Survival at 10 Years
5-year Kaplan Meier Survival Estimate
|
96.16 percentage of participants
Interval 88.55 to 98.75
|
|
Implant Survival at 10 Years
7-year Kaplan Meier Survival Estimate
|
92.87 percentage of participants
Interval 83.58 to 97.0
|
|
Implant Survival at 10 Years
10-year Kaplan Meier Survival Estimate
|
91.01 percentage of participants
Interval 80.87 to 95.91
|
SECONDARY outcome
Timeframe: Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-opPopulation: All 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 |
Patients Who Received the Continuum Metal on Metal System
n=83 Participants
Patients requiring total hip arthroplasty, who met the inclusion/exclusion criteria and received the Continuum Metal on Metal System
|
|---|---|
|
The Harris Hip Score (HHS)
Preop
|
45.1 score on a scale
Standard Deviation 12.3
|
|
The Harris Hip Score (HHS)
6-week
|
85.1 score on a scale
Standard Deviation 14.5
|
|
The Harris Hip Score (HHS)
6-month
|
93.2 score on a scale
Standard Deviation 11.3
|
|
The Harris Hip Score (HHS)
1-year
|
92.2 score on a scale
Standard Deviation 12.7
|
|
The Harris Hip Score (HHS)
2-year
|
93.8 score on a scale
Standard Deviation 10.1
|
|
The Harris Hip Score (HHS)
3-year
|
93.6 score on a scale
Standard Deviation 12.9
|
|
The Harris Hip Score (HHS)
5-year
|
95 score on a scale
Standard Deviation 9.0
|
|
The Harris Hip Score (HHS)
7-year
|
93.5 score on a scale
Standard Deviation 11.6
|
|
The Harris Hip Score (HHS)
10-year
|
91.0 score on a scale
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-opPopulation: All study patients
SF12: 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 |
Patients Who Received the Continuum Metal on Metal System
n=83 Participants
Patients requiring total hip arthroplasty, who met the inclusion/exclusion criteria and received the Continuum Metal on Metal System
|
|---|---|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
Preop SF-12 (Physical)
|
29.8 score on a scale
Standard Deviation 7.4
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
6-week SF-12 (Physical)
|
41.8 score on a scale
Standard Deviation 8.5
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
6-month SF-12 (Physical)
|
48.4 score on a scale
Standard Deviation 9.2
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
1-year SF-12 (Physical)
|
49.5 score on a scale
Standard Deviation 9.2
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
2-year SF-12 (Physical)
|
50.0 score on a scale
Standard Deviation 8.1
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
3-year SF-12 (Physical)
|
50.7 score on a scale
Standard Deviation 8.7
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
5-year SF-12 (Physical)
|
49.5 score on a scale
Standard Deviation 9.8
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
7-year SF-12 (Physical)
|
48.8 score on a scale
Standard Deviation 10.5
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
10-year SF-12 (Physical)
|
47.9 score on a scale
Standard Deviation 9.6
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
Preop SF-12 (Mental)
|
52.4 score on a scale
Standard Deviation 10.7
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
6-week SF-12 (Mental)
|
56.3 score on a scale
Standard Deviation 8.4
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
6-month SF-12 (Mental)
|
56.6 score on a scale
Standard Deviation 7.2
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
1-year SF-12 (Mental)
|
56.3 score on a scale
Standard Deviation 7.3
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
2-year SF-12 (Mental)
|
57.6 score on a scale
Standard Deviation 7.2
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
3-year SF-12 (Mental)
|
57.9 score on a scale
Standard Deviation 6.0
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
5-year SF-12 (Mental)
|
57.4 score on a scale
Standard Deviation 6.3
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
7-year SF-12 (Mental)
|
55.6 score on a scale
Standard Deviation 8.3
|
|
The Subject Quality-of-Life (SF-12): Physical and Mental Socres
10-year SF-12 (Mental)
|
57.3 score on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Immediate-postop, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op.Population: All study patients
Radiographic evaluation was performed in order to identify potential adverse events. Investigators at each site were responsible for reviewing the radiological images for any abnormal or significant findings and reporting adverse events if applicable. In addition, an independent radiographic reviewer performed assessments of radiographic films in terms of evidence of radiolucencies, osteolysis, subsidence, acetabular cup migration, and change in acetabular cup angle at 6 months, 1 year and 2 year post-operation. Outcomes included numbers of reported findings per anatomical position and time point.
Outcome measures
| Measure |
Patients Who Received the Continuum Metal on Metal System
n=83 Participants
Patients requiring total hip arthroplasty, who met the inclusion/exclusion criteria and received the Continuum Metal on Metal System
|
|---|---|
|
Radiographic Evaluations
Total significant findings
|
34 number of findings
|
|
Radiographic Evaluations
Acetabular side
|
6 number of findings
|
|
Radiographic Evaluations
Femoral side
|
26 number of findings
|
|
Radiographic Evaluations
Other
|
2 number of findings
|
|
Radiographic Evaluations
Immed-postop
|
1 number of findings
|
|
Radiographic Evaluations
6-week
|
5 number of findings
|
|
Radiographic Evaluations
6-month
|
2 number of findings
|
|
Radiographic Evaluations
1-year
|
5 number of findings
|
|
Radiographic Evaluations
2-year
|
6 number of findings
|
|
Radiographic Evaluations
3-year
|
4 number of findings
|
|
Radiographic Evaluations
5-year
|
3 number of findings
|
|
Radiographic Evaluations
7-year
|
6 number of findings
|
|
Radiographic Evaluations
10-year
|
2 number of findings
|
SECONDARY outcome
Timeframe: Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.Population: The numbers of participants listed for metal ion concentrations indicate the number of participants who showed metal ion levels above the detectable limit.
Metal ion levels (cobalt, chromium and titanium) were analyzed by an approved Central Laboratory at the time points listed below for all study subjects enrolled in this study. In addition, prior to a revision surgery, a blood draw for metal ion data collection was performed.
Outcome measures
| Measure |
Patients Who Received the Continuum Metal on Metal System
n=76 Participants
Patients requiring total hip arthroplasty, who met the inclusion/exclusion criteria and received the Continuum Metal on Metal System
|
|---|---|
|
Metal Ion Concentration in Blood
6-Month (Cobalt)
|
2.2 ng/ml
Standard Deviation 1.4
|
|
Metal Ion Concentration in Blood
1-year (Cobalt)
|
2.9 ng/ml
Standard Deviation 3.6
|
|
Metal Ion Concentration in Blood
Preop (Chromium)
|
1.1 ng/ml
Standard Deviation 0.6
|
|
Metal Ion Concentration in Blood
6-month (Chromium)
|
1.8 ng/ml
Standard Deviation 1.0
|
|
Metal Ion Concentration in Blood
1-year (Chromium)
|
2.3 ng/ml
Standard Deviation 2.0
|
|
Metal Ion Concentration in Blood
2-year (Chromium)
|
2.4 ng/ml
Standard Deviation 1.6
|
|
Metal Ion Concentration in Blood
5-year (Chromium)
|
2.2 ng/ml
Standard Deviation 1.3
|
|
Metal Ion Concentration in Blood
Preop (Cobalt)
|
1.2 ng/ml
Standard Deviation 1.1
|
|
Metal Ion Concentration in Blood
2-year (Cobalt)
|
2.2 ng/ml
Standard Deviation 1.1
|
|
Metal Ion Concentration in Blood
5-year (Cobalt)
|
2.3 ng/ml
Standard Deviation 1.9
|
|
Metal Ion Concentration in Blood
Preop (Titanium)
|
4.9 ng/ml
Standard Deviation 1.2
|
|
Metal Ion Concentration in Blood
6-month (Titanium)
|
5.4 ng/ml
Standard Deviation 1.9
|
|
Metal Ion Concentration in Blood
1-year (Titanium)
|
6.1 ng/ml
Standard Deviation 0.7
|
|
Metal Ion Concentration in Blood
2-year (Titanium)
|
4.6 ng/ml
Standard Deviation 2.3
|
|
Metal Ion Concentration in Blood
5-year (Titanium)
|
NA ng/ml
Standard Deviation 0
At 5 years post-surgery all patients had titanium ion concentrations below the detectable limit of \<5.0 ng/ml.
|
SECONDARY outcome
Timeframe: Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-opPopulation: All study patients. At preoperative, EQ-5D scores of only 57 patients (not collected at the US site) were available for this report.
EQ5D: The 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, self care, 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. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573; negative numbers correspond to a self-assessed health state worse than being dead. The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The warst health you can imagine') where the patient reports his/her self-rated health.
Outcome measures
| Measure |
Patients Who Received the Continuum Metal on Metal System
n=57 Participants
Patients requiring total hip arthroplasty, who met the inclusion/exclusion criteria and received the Continuum Metal on Metal System
|
|---|---|
|
EQ5D
Preop EQ-5D-5L
|
0.6 units on a scale
Standard Deviation 0.2
|
|
EQ5D
6-week EQ-5D-5L
|
0.8 units on a scale
Standard Deviation 0.1
|
|
EQ5D
6-month EQ-5D-5L
|
0.9 units on a scale
Standard Deviation 0.1
|
|
EQ5D
1-year EQ-5D-5L
|
0.9 units on a scale
Standard Deviation 0.1
|
|
EQ5D
2-year EQ-5D-5L
|
1.0 units on a scale
Standard Deviation 0.1
|
|
EQ5D
3-year EQ-5D-5L
|
1.0 units on a scale
Standard Deviation 0.1
|
|
EQ5D
5-year EQ-5D-5L
|
0.9 units on a scale
Standard Deviation 0.2
|
|
EQ5D
7-year EQ-5D-5L
|
0.9 units on a scale
Standard Deviation 0.1
|
|
EQ5D
10-year EQ-5D-5L
|
0.9 units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.Population: The numbers of participants listed for renal function demonstrated the number of participants tested.
Renal function (BUN and Creatinine) were analyzed by an approved Central Laboratory at the time points listed below for all study subjects enrolled in this study. In addition, prior to a revision surgery, a blood draw for metal ion data collection was performed.
Outcome measures
| Measure |
Patients Who Received the Continuum Metal on Metal System
n=76 Participants
Patients requiring total hip arthroplasty, who met the inclusion/exclusion criteria and received the Continuum Metal on Metal System
|
|---|---|
|
Creatine Concentration and BUN
Preop (Creatine)
|
0.8 mg/dl
Standard Deviation 0.2
|
|
Creatine Concentration and BUN
6-month (Creatine)
|
0.8 mg/dl
Standard Deviation 0.2
|
|
Creatine Concentration and BUN
1-year (Creatine)
|
0.9 mg/dl
Standard Deviation 0.2
|
|
Creatine Concentration and BUN
2-year (Creatine)
|
0.9 mg/dl
Standard Deviation 0.2
|
|
Creatine Concentration and BUN
5-year (Creatine)
|
0.9 mg/dl
Standard Deviation 0.2
|
|
Creatine Concentration and BUN
Preop (BUN)
|
14.9 mg/dl
Standard Deviation 4.9
|
|
Creatine Concentration and BUN
6-month (BUN)
|
14.3 mg/dl
Standard Deviation 5.1
|
|
Creatine Concentration and BUN
1-year (BUN)
|
14.1 mg/dl
Standard Deviation 5.0
|
|
Creatine Concentration and BUN
2-year (BUN)
|
14.2 mg/dl
Standard Deviation 5.9
|
|
Creatine Concentration and BUN
5-year (BUN)
|
15.2 mg/dl
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.Population: The numbers of participants listed for renal function demonstrated the number of participants tested.
Renal function (BUN, Creatinine and GFR) were analyzed by an approved Central Laboratory at the time points listed below for all study subjects enrolled in this study. In addition, prior to a revision surgery, a blood draw for metal ion data collection was performed.
Outcome measures
| Measure |
Patients Who Received the Continuum Metal on Metal System
n=76 Participants
Patients requiring total hip arthroplasty, who met the inclusion/exclusion criteria and received the Continuum Metal on Metal System
|
|---|---|
|
Calculated GFR
Preop (GRF)
|
99.3 mL/min/1.73 m²
Standard Deviation 34.5
|
|
Calculated GFR
6-month (GRF)
|
101.8 mL/min/1.73 m²
Standard Deviation 26.4
|
|
Calculated GFR
1-year (GRF)
|
98 mL/min/1.73 m²
Standard Deviation 23.8
|
|
Calculated GFR
2-year (GRF)
|
92.1 mL/min/1.73 m²
Standard Deviation 24.0
|
|
Calculated GFR
5-year (GRF)
|
83.4 mL/min/1.73 m²
Standard Deviation 16.0
|
Adverse Events
Patients Who Received the Continuum Metal on Metal System
Serious events: 25 serious events
Other events: 62 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Patients Who Received the Continuum Metal on Metal System
n=83 participants at risk
Patients requiring total hip arthroplasty, who meet the inclusion/exclusion criteria and received the Continuum Metal on Metal System
|
|---|---|
|
General disorders
Other General Complication
|
8.4%
7/83 • Number of events 7 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncological events
|
3.6%
3/83 • Number of events 3 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Nervous system disorders
Neurological events
|
3.6%
3/83 • Number of events 3 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Cardiac disorders
Cardiovascular events
|
6.0%
5/83 • Number of events 5 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal (non-hip) events
|
4.8%
4/83 • Number of events 6 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatological events
|
1.2%
1/83 • Number of events 1 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Respiratory events
|
1.2%
1/83 • Number of events 1 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Infections and infestations
Infection (hip), superficial
|
1.2%
1/83 • Number of events 1 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Gastrointestinal disorders
Gastrointestinal events
|
1.2%
1/83 • Number of events 1 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Surgical and medical procedures
Delayed Wound Healing
|
1.2%
1/83 • Number of events 1 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Musculoskeletal and connective tissue disorders
Instability
|
1.2%
1/83 • Number of events 1 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Blood and lymphatic system disorders
Hematoma
|
1.2%
1/83 • Number of events 1 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Endocrine disorders
Endocrine
|
1.2%
1/83 • Number of events 1 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Infections and infestations
Infection (non-hip)
|
1.2%
1/83 • Number of events 1 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Ear and labyrinth disorders
ENT
|
1.2%
1/83 • Number of events 1 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
1.2%
1/83 • Number of events 1 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Musculoskeletal and connective tissue disorders
Other Hip Related Radiographic Finding
|
1.2%
1/83 • Number of events 1 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
Other adverse events
| Measure |
Patients Who Received the Continuum Metal on Metal System
n=83 participants at risk
Patients requiring total hip arthroplasty, who meet the inclusion/exclusion criteria and received the Continuum Metal on Metal System
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal (non-hip)
|
42.2%
35/83 • Number of events 58 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
General disorders
Other General Complication
|
18.1%
15/83 • Number of events 19 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Musculoskeletal and connective tissue disorders
Thigh/Groin/Hip Pain
|
18.1%
15/83 • Number of events 22 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Cardiac disorders
Cardiovascular
|
12.0%
10/83 • Number of events 13 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Gastrointestinal disorders
Gastrointestinal
|
10.8%
9/83 • Number of events 11 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Renal and urinary disorders
Genitourinary / Renal
|
8.4%
7/83 • Number of events 7 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Musculoskeletal and connective tissue disorders
Other Hip Related Radiographic Finding
|
8.4%
7/83 • Number of events 7 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Nervous system disorders
Neurological
|
6.0%
5/83 • Number of events 7 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Respiratory
|
6.0%
5/83 • Number of events 5 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
4.8%
4/83 • Number of events 4 • Safety was evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) throughout the participation of the study from enrollment to 10-year follow-up
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place