ArthritisHRANCT02983292
PyroTITAN Humeral Resurfacing Arthroplasty (HRA)
An observational study of Arthritis, run by Smith & Nephew, Inc. at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthritis
- What is being tested?
- PyroTITAN™ HRA
- Type of treatment
- Medical device
- How many people
- 137 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2016to 8 Feb 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who require humeral head resurfacing arthroplasty.
Who may be able to join
- Patients of either sex will be included, if they:
- Present (prospective cohort) or presented (retrospective cohort) for primary shoulder surface replacement or arthroplasty with any of the following diagnoses:
- Osteoarthritis
- Rheumatoid / Inflammatory Arthritis
- Post-traumatic arthritis.
- Focal and large (Hill-Sachs) osteochondral defects.
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- 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.
- Subject is able to or capable of providing consent to participate in the clinical investigation.
- Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires.
- Subject is at least 18 years of age and skeletally mature at the time of surgery.
Who cannot join
- Patients will be excluded from participation if they:
- Has/had destruction of the proximal humerus to preclude rigid fixation of the humeral component.
- Has/had insufficient bone quality as determined by intra- operative evaluation.
- Has/had arthritis with defective rotator cuff.
- Has/had had a failed rotator cuff surgery.
- Has/had loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
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- Has/had evidence of active infection.
- Present/presented with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint).
- 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.
- Are/were skeletally immature.
- Has/had a known allergic reaction to PyroCarbon.
- 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.
- Has/had known, active metastatic or neoplastic disease.
- Are/were taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
- Are/were under 21 years of age or over 75.
- Require/required glenoid replacement.
- Retrospective patients cannot be enrolled if they are two year or greater out from the index surgery.
- Women, who are pregnant or are planning to become pregnant.
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Brisbane Hand and Upper Limb Research Institute
Brisbane, Queensland, 4001
About this study
Official 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
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.
Read the detailed description
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. The results will be compared to data collected in a prior study conducted before implementing the new proof test. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected retrospectively and prospectively for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty.
137 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for up to 60 months.
- Conditions
- Arthritis
- Being tested
- PyroTITAN™ HRA
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyroTITAN™ HRADevice
Humeral Resurfacing
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Survival: Kaplan-Meir Estimate
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.
Measured: 2 years
Secondary outcomes (9)
Number of Participants With Device-Related Adverse Events
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.
Measured: Post-operatively to 5-Years
Cumulative Device Success
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.
Measured: 2-Years and 5-Years
Cumulative Device Survival
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.
Measured: 2-Years and 5-Years
Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score
ASES scores range from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition.
Measured: Baseline, 2-Years and 5-Years
Device Functionality: Visual Analog Scale (VAS) - Pain
The VAS Pain score range was from 0 to 100, with 0 representing no pain and 100 representing the worse possible pain.
Measured: Baseline, 2-Years and 5-Years
Device Functionality: Visual Analog Scale (VAS) - Satisfaction
The VAS Satisfaction score range was from 0 to 100, with 0 representing the worst result and 100 representing the best result.
Measured: Baseline, 2-Years and 5-Years
Device Functionality: Western Ontario Osteoarthritis Score (WOOS)
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.
Measured: Baseline, 2-Years and 5-Years
Device Functionality: QuickDASH Outcome Measure
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.
Measured: Baseline, 2-Years and 5-Years
Device Functionality: Constant Murley Score (CMS)
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.
Measured: Baseline, 2-Years and 5-Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startOct 2016
- Primary completion8 Feb 2023
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Belinda Larson, Study director, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983292
- Sponsor's protocol ID
- T-HRA-003
- Acronym
- HRA
- Status last verified
- Jun 2024
- First submitted
- 1 Dec 2016
- Last updated
- 4 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02983292
- Acronym / sponsor ID
- HRA / T-HRA-003
- Conditions
- Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Posted 4 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The results will be compared to data collected in a prior study conducted before implementing the new proof test. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected retrospectively and prospectively for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty.
137 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for up to 60 months.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who require humeral head resurfacing arthroplasty.
Key inclusion criteria (10 listed)
- Present (prospective cohort) or presented (retrospective cohort) for primary shoulder surface replacement or arthroplasty with any of the following diagnoses:
- 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.
- Subject is able to or capable of providing consent to participate in the clinical investigation.
- Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires.
- Subject is at least 18 years of age and skeletally mature at the time of surgery.
Key exclusion criteria (18 listed)
- Has/had destruction of the proximal humerus to preclude rigid fixation of the humeral component.
- Has/had insufficient bone quality as determined by intra- operative evaluation.
- Has/had arthritis with defective rotator cuff.
- Has/had had a failed rotator cuff surgery.
- Has/had loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyroTITAN™ HRAHumeral Resurfacing | Device | – |
Primary outcome
Device Survival: Kaplan-Meir Estimate
Time frame: 2 years
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.
9 secondary outcomes
Number of Participants With Device-Related Adverse Events
Time frame: Post-operatively to 5-Years
Cumulative Device Success
Time frame: 2-Years and 5-Years
Cumulative Device Survival
Time frame: 2-Years and 5-Years
Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Baseline, 2-Years and 5-Years
Device Functionality: Visual Analog Scale (VAS) - Pain
Time frame: Baseline, 2-Years and 5-Years
Device Functionality: Visual Analog Scale (VAS) - Satisfaction
Time frame: Baseline, 2-Years and 5-Years
Device Functionality: Western Ontario Osteoarthritis Score (WOOS)
Time frame: Baseline, 2-Years and 5-Years
Device Functionality: QuickDASH Outcome Measure
Time frame: Baseline, 2-Years and 5-Years
Device Functionality: Constant Murley Score (CMS)
Time frame: Baseline, 2-Years and 5-Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belinda Larson study director
Smith & Nephew, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by Smith & Nephew, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Survival: Kaplan-Meir Estimate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.