Trial Outcomes & Findings for PyroTITAN Humeral Resurfacing Arthroplasty (HRA) (NCT NCT02983292)
NCT ID: NCT02983292
Last Updated: 2024-11-04
Results Overview
Device survival was defined as the absence of device fracture at the two year time-point. Percentage of participants with survival of the device estimated using the Kaplan-Meier method.
Recruitment status
COMPLETED
Target enrollment
137 participants
Primary outcome timeframe
2 years
Results posted on
2024-11-04
Participant Flow
Participants were enrolled in the study at one (1) site in Australia and participated between 24 Oct 2016 to 08 Feb 2023.
Overall, 137 participants were enrolled in the study, and fifty-two (52) participants discontinued from the study before completion.
Participant milestones
| Measure |
PyroTITAN™ HRA Shoulder System
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Overall Study
STARTED
|
137
|
|
Overall Study
COMPLETED
|
85
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
PyroTITAN™ HRA Shoulder System
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Overall Study
Participant unwell & cannot travel
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Participant withdrew consent
|
2
|
|
Overall Study
Revision
|
7
|
|
Overall Study
Death
|
1
|
|
Overall Study
Participant did not return due to COVID-19 related lockdown
|
30
|
|
Overall Study
Participant failed to return for follow-up visits
|
6
|
|
Overall Study
Participant relocation
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PyroTITAN™ HRA Shoulder System
n=137 Participants
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 12.7 • n=137 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=137 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=137 Participants
|
|
Region of Enrollment
Australia
|
137 participants
n=137 Participants
|
|
Dominant Side
Right
|
123 Participants
n=137 Participants
|
|
Dominant Side
Left
|
14 Participants
n=137 Participants
|
|
Dominant Side
Missing
|
0 Participants
n=137 Participants
|
|
Body Mass Index (BMI)
|
30.1 kg/m^2
STANDARD_DEVIATION 5.0 • n=137 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants with data available at the time frame indicated
Device survival was defined as the absence of device fracture at the two year time-point. Percentage of participants with survival of the device estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
PyroTITAN™ HRA Shoulder System
n=114 Participants
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Device Survival: Kaplan-Meir Estimate
|
98.47 percentage of participants
Interval 96.35 to 100.0
|
SECONDARY outcome
Timeframe: Post-operatively to 5-YearsPopulation: Participants with data available at the time frame indicated
Count of participants with device-related Non-Serious \& Serious Adverse Events were the event was related to device use (e.g., component breakage) as determined by investigator assessment.
Outcome measures
| Measure |
PyroTITAN™ HRA Shoulder System
n=137 Participants
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Number of Participants With Device-Related Adverse Events
Device-Related Non-Serious Adverse Event
|
6 Participants
|
|
Number of Participants With Device-Related Adverse Events
Device-Related Serious Adverse Event
|
6 Participants
|
SECONDARY outcome
Timeframe: 2-Years and 5-YearsPopulation: Participants with data available at the time frame indicated
Device success was defined as the absence of device fracture over time. Cumulative device success was determined by the percentage of participants with no device fractures by the two year \& five year time-points.
Outcome measures
| Measure |
PyroTITAN™ HRA Shoulder System
n=118 Participants
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Cumulative Device Success
2-Years
|
98.5 percentage of participants
Interval 96.3 to 100.0
|
|
Cumulative Device Success
5-Years
|
97.5 percentage of participants
Interval 94.6 to 100.0
|
SECONDARY outcome
Timeframe: 2-Years and 5-YearsPopulation: Participants with data available at the time frame indicated
Device survival was defined as the absence of device revision over time. Cumulative device survival was determined by the percentage of participants with no device revisions by the two year \& five year time-points.
Outcome measures
| Measure |
PyroTITAN™ HRA Shoulder System
n=118 Participants
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Cumulative Device Survival
2-Years
|
96.24 percentage of participants
Interval 93.01 to 99.48
|
|
Cumulative Device Survival
5-Years
|
94.17 percentage of participants
Interval 89.92 to 98.42
|
SECONDARY outcome
Timeframe: Baseline, 2-Years and 5-YearsPopulation: Participants with data available at the time frame indicated
ASES scores range from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition.
Outcome measures
| Measure |
PyroTITAN™ HRA Shoulder System
n=125 Participants
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score
Baseline
|
31.1 score on a scale
Standard Deviation 19.7
|
|
Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score
2-Years
|
83.7 score on a scale
Standard Deviation 18.8
|
|
Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score
5-Years
|
88.1 score on a scale
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: Baseline, 2-Years and 5-YearsPopulation: Participants with data available at the time frame indicated
The VAS Pain score range was from 0 to 100, with 0 representing no pain and 100 representing the worse possible pain.
Outcome measures
| Measure |
PyroTITAN™ HRA Shoulder System
n=131 Participants
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Device Functionality: Visual Analog Scale (VAS) - Pain
Baseline
|
66 score on a scale
Standard Deviation 21
|
|
Device Functionality: Visual Analog Scale (VAS) - Pain
2-Years
|
12.4 score on a scale
Standard Deviation 17.4
|
|
Device Functionality: Visual Analog Scale (VAS) - Pain
5-Years
|
9.5 score on a scale
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: Baseline, 2-Years and 5-YearsPopulation: Participants with data available at the time frame indicated
The VAS Satisfaction score range was from 0 to 100, with 0 representing the worst result and 100 representing the best result.
Outcome measures
| Measure |
PyroTITAN™ HRA Shoulder System
n=130 Participants
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Device Functionality: Visual Analog Scale (VAS) - Satisfaction
Baseline
|
15.6 score on a scale
Standard Deviation 18.5
|
|
Device Functionality: Visual Analog Scale (VAS) - Satisfaction
2-Years
|
89.6 score on a scale
Standard Deviation 18.9
|
|
Device Functionality: Visual Analog Scale (VAS) - Satisfaction
5-Years
|
92.5 score on a scale
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: Baseline, 2-Years and 5-YearsPopulation: Participants with data available at the time frame indicated
The WOOS score was based on 19 questions ranging from 0 to 100 with 0 being the best result and 100 being the worst result. A lower score indicated a better outcome.
Outcome measures
| Measure |
PyroTITAN™ HRA Shoulder System
n=133 Participants
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Device Functionality: Western Ontario Osteoarthritis Score (WOOS)
Baseline
|
66.7 score on a scale
Standard Deviation 14.1
|
|
Device Functionality: Western Ontario Osteoarthritis Score (WOOS)
2-Years
|
14.2 score on a scale
Standard Deviation 89.1
|
|
Device Functionality: Western Ontario Osteoarthritis Score (WOOS)
5-Years
|
11.6 score on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: Baseline, 2-Years and 5-YearsPopulation: Participants with data available at the time frame indicated
The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) score ranged from 0 (no disability) to 100 (most severe disability) based on 11 questions scored 1 to 5 each (for disability/symptoms) and 4 questions scored 1 to 5 each (for performance/sport/work). A lower score indicates a better outcome.
Outcome measures
| Measure |
PyroTITAN™ HRA Shoulder System
n=137 Participants
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Device Functionality: QuickDASH Outcome Measure
Baseline
|
49.5 score on a scale
Standard Deviation 16
|
|
Device Functionality: QuickDASH Outcome Measure
2-Years
|
15.5 score on a scale
Standard Deviation 17.1
|
|
Device Functionality: QuickDASH Outcome Measure
5-Years
|
14.5 score on a scale
Standard Deviation 17
|
SECONDARY outcome
Timeframe: Baseline, 2-Years and 5-YearsPopulation: Participants with data available at the time frame indicated
The Constant Murley Score (CMS) is a 100-point scale composed of individual parameters. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and Range of Motion (ROM) (40 points). Subscales are combined to indicate a total CMS score. The total CMS score ranges from 0 to 100 points, with higher scores indicating a better outcome.
Outcome measures
| Measure |
PyroTITAN™ HRA Shoulder System
n=97 Participants
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Device Functionality: Constant Murley Score (CMS)
Baseline
|
50.7 score on a scale
Standard Deviation 15
|
|
Device Functionality: Constant Murley Score (CMS)
2-Years
|
79.9 score on a scale
Standard Deviation 10.3
|
|
Device Functionality: Constant Murley Score (CMS)
5-Years
|
83.7 score on a scale
Standard Deviation 10.9
|
Adverse Events
PyroTITAN™ HRA Shoulder System
Serious events: 47 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PyroTITAN™ HRA Shoulder System
n=137 participants at risk
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Right shoulder rotator cuff pain
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Duke C Colon Cancer
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Surgical and medical procedures
Urosepsis following surgery for prostate cancer biopsy
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Meniscus tear in left knee
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cancerous nodule thyroid
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Locking right knee
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Fractured left scaphoid following a fall.
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
worsening OA left knee
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Worsening of OA in right knee
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Back pain exacerbated
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Deterioration of left shoulder secondary to pre-existing condition (avacular necrosis).
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Thoracic outlet syndrome progression
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Right shoulder rotator cuff impingement
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Right shoulder posterior instability
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Joint metallosis in right (operative) shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Right shoulder OA worsening
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign prostatic hyperplasia
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Cardiac disorders
Cardiac chest pain
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Aggravation of OA in left thumb and wrist
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Persistent right rotator cuff pain
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Anterior shoulder pain due to subscap impingement on the anterior aspect of the hemiarthroplasty
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Product Issues
Fracture of PyroTITAN prosthesis.
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Infections and infestations
Cellulitis and recurring infection in right knee
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Left shoulder rotator cuff tear
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Injury, poisoning and procedural complications
Broken right ankle
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Product Issues
Undisplaced fracture of implant
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Worsening of OA in left shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Worsening knee OA and pain
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Difficulty with function and ROM in left operative shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Ongoing pain in left shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Right subscapular bursa irritation.
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Right shoulder full thickness tear
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Right leg cellulitis
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff tendonitis left shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Exacerbation of OA in right shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Exacerabated right shoulder OA.
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Cellulitis in left leg.
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Injury, poisoning and procedural complications
Knife injury to left arm
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Thoracic outlet syndrome progression.
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff impingement left shoulder.
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
worsening osteoarthritis left wrist
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Exacerbation of OA right knee.
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Subscapular bursa irritation left shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Product Issues
Fractured prosthesis
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Worsening left shoulder osteoartritis
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Ongoing pain in right operative shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
worsening Osteoarthritis in right foot
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Worsening left shoulder osteoarthritis.
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Worsening right shoulder arthritis
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Worsenning osteoarthritis bilateral knees.
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Infections and infestations
Pneumonia
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Exacerbation of lower back nerve pain
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Infections and infestations
Infection left shoulder wound
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
Other adverse events
| Measure |
PyroTITAN™ HRA Shoulder System
n=137 participants at risk
Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Minor rotator cuff tendonitis left shoulder.
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Suspected stress fracture of posterior glenoid osteophyte right shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Bursitis right shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Squeaking right shoulder after physiotherapy.
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Cuff pain right shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Suspected rotator cuff tendonitis left shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Suspected rotator cuff tendonitis right.
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Crepitation around right shoulder joint with activity
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Occasional pain up right arm
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Audible squeaking left pyrotitan shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Audible squeak on flexion/extension of operative shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
Persistent operative shoulder pain
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Skin and subcutaneous tissue disorders
Skin irritation of scar in operative shoulder
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
|
Musculoskeletal and connective tissue disorders
right shoulder stiffness
|
0.73%
1/137 • Number of events 1 • Surgery to end of study visit, up to 5 years
All postoperative device-related \& surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, \& circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
|
Additional Information
Dr. Manvendra Saxena
Senior Specialist-Clinical Study Management
Phone: +61 455 870 175
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place