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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02983292
Registration number
NCT02983292
Ethics application status
Date submitted
1/12/2016
Date registered
6/12/2016
Date last updated
4/11/2024
Titles & IDs
Public title
PyroTITAN Humeral Resurfacing Arthroplasty (HRA)
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Scientific title
A Clinical and Radiological Study to Evaluate the Safety and Efficacy of the PyroTITAN Humeral Resurfacing Arthroplasty (HRA) Device in a New Cohort of Patients After Product Re-Release
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Secondary ID [1]
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T-HRA-003
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Universal Trial Number (UTN)
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Trial acronym
HRA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - PyroTITAN™ HRA
Treatment: Devices: PyroTITAN™ HRA
Humeral Resurfacing
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Device Survival: Kaplan-Meir Estimate
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Assessment method [1]
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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.
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Number of Participants With Device-Related Adverse Events
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Assessment method [1]
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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.
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Timepoint [1]
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Post-operatively to 5-Years
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Secondary outcome [2]
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Cumulative Device Success
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Assessment method [2]
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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.
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Timepoint [2]
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2-Years and 5-Years
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Secondary outcome [3]
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Cumulative Device Survival
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Assessment method [3]
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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.
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Timepoint [3]
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2-Years and 5-Years
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Secondary outcome [4]
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Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score
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Assessment method [4]
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ASES scores range from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition.
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Timepoint [4]
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Baseline, 2-Years and 5-Years
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Secondary outcome [5]
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Device Functionality: Visual Analog Scale (VAS) - Pain
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Assessment method [5]
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The VAS Pain score range was from 0 to 100, with 0 representing no pain and 100 representing the worse possible pain.
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Timepoint [5]
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Baseline, 2-Years and 5-Years
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Secondary outcome [6]
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Device Functionality: Visual Analog Scale (VAS) - Satisfaction
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Assessment method [6]
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The VAS Satisfaction score range was from 0 to 100, with 0 representing the worst result and 100 representing the best result.
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Timepoint [6]
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Baseline, 2-Years and 5-Years
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Secondary outcome [7]
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Device Functionality: Western Ontario Osteoarthritis Score (WOOS)
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline, 2-Years and 5-Years
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Secondary outcome [8]
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Device Functionality: QuickDASH Outcome Measure
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline, 2-Years and 5-Years
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Secondary outcome [9]
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Device Functionality: Constant Murley Score (CMS)
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, 2-Years and 5-Years
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Eligibility
Key inclusion criteria
Patients of either sex will be included, if they:
1. Present (prospective cohort) or presented (retrospective cohort) for primary shoulder surface replacement or arthroplasty with any of the following diagnoses:
1. Osteoarthritis
2. Rheumatoid / Inflammatory Arthritis
3. Post-traumatic arthritis.
4. Focal and large (Hill-Sachs) osteochondral defects.
2. Subject receives (prospective cohort) the PyroTITAN HRA device after the re-release of the product or received (retrospective cohort) the PyroTITAN HRA device after the re- release of the product and is enrolled in the study prior to their two-year follow-up visit.
3. Subject is able to or capable of providing consent to participate in the clinical investigation.
4. Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires.
5. Subject is at least 18 years of age and skeletally mature at the time of surgery.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients will be excluded from participation if they:
1. Has/had destruction of the proximal humerus to preclude rigid fixation of the humeral component.
2. Has/had insufficient bone quality as determined by intra- operative evaluation.
3. Has/had arthritis with defective rotator cuff.
4. Has/had had a failed rotator cuff surgery.
5. Has/had loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
6. Has/had evidence of active infection.
7. Present/presented with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint).
8. Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow- up visits prescribed by the protocol.
9. Are/were skeletally immature.
10. Has/had a known allergic reaction to PyroCarbon.
11. Has/had other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible.
12. Has/had known, active metastatic or neoplastic disease.
13. Are/were taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
14. Are/were under 21 years of age or over 75.
15. Require/required glenoid replacement.
16. Retrospective patients cannot be enrolled if they are two year or greater out from the index surgery.
17. Women, who are pregnant or are planning to become pregnant.
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/02/2023
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Sample size
Target
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Accrual to date
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Final
137
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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The Brisbane Hand and Upper Limb Research Institute - Brisbane
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Recruitment postcode(s) [1]
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4001 - Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Smith & Nephew, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™ HRA device following the implementation of a new proof test to identify and eliminate devices with sub-standard mechanical integrity.
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Trial website
https://clinicaltrials.gov/study/NCT02983292
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Belinda Larson
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Address
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Smith & Nephew, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/92/NCT02983292/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/92/NCT02983292/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02983292
Download to PDF