ArthritisCHRANCT02405208
A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
An observational study of Arthritis, run by Smith & Nephew, Inc. at 5 sites in 4 countries.
Trial summary
This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Arthritis
- What is being tested?
- PyroTITAN HRA
- Type of treatment
- Medical device
- How many people
- 156 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Aug 2010to Sep 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 21 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 selected for inclusion will present 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.
- 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 21 years of age and skeletally mature at the time of surgery.
Who cannot join
- Have destruction of the proximal humerus to preclude rigid fixation of the humeral component.
- Insufficient bone quality as determined by intra-operative evaluation.
- Have arthritis with defective rotator cuff.
- Have had a failed rotator cuff surgery.
- Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- Have evidence of active infection.
Show all 17Show fewer
- Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexis 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 skeletally immature.
- Have a known allergic reaction to pyrocarbon.
- Have 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.
- Are currently participating in another clinical study.
- Have known, active metastatic or neoplastic disease.
- Are taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
- Are under 21 years of age or over 75.
- .
- Require glenoid replacement (Glenoid Classification).
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Australia2 sites
Brisbane Hand & Upper Limb Clinic
Brisbane, Queensland, 4001
Barwon Health
Geelong, Victoria, 3220
United Kingdom1 site
Wrightington Hospital
Wigan, Wrightington, WN6 9EP
About this study
This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement.
Read the detailed description
This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty.
The investigation will be conducted by up to 10 International surgeons experienced in HRA. 387 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for 10 years.
- 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 using the PyroTITAN HRA device
| Study group | Role | What they receive |
|---|---|---|
| Primary cohort | Primary cohort will receive the PyroTITAN HRA device Receives: Device: PyroTITAN HRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Survival
Clinical success was determined by the percentage of shoulders with device survival. Survival of the device was measured by the Kaplan-Meier survival estimate with survival defined as all the following:
- Device remained implanted
- Absence of device-related complications requiring surgical replacement, removal, or augmentation of components
- Freedom from chronic dislocation
Measured: up to 117 months
Secondary outcomes (8)
Radiographic Success
Radiographic success determined by:
- No evidence of device failure, specifically progressive migration or implant loosening
- Anatomic alignment is a criterion that may be included in the definition of success in some investigations
Measured: 2 years, 3 years, 4 years, 5 years, 8 years and 10 years
ASES Score
The ASES Shoulder Score is a functional outcome tool that has been validated for various shoulder conditions. ASES score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition.
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Visual Analog Scale (VAS) Pain Score
The Visual Analog Scale (VAS) Pain Score ranges from 0 to 100, with 0 representing no pain (i.e., the best outcome) and 100 representing the worst possible pain (i.e., the worst outcome).
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Visual Analog Scale (VAS) Satisfaction Score
Patient satisfaction determined by the Visual Analog Scale (VAS) Satisfaction score. VAS Satisfaction scores range from 0 to 100, with 0 representing the lowest level of satisfaction (i.e., the worst possible outcome) and 100 representing the highest level of satisfaction (i.e., the best possible outcome).
Measured: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
The Western Ontario of the Shoulder Index (WOOS) Score
The WOOS Score is a quality of life questionnaire that has been validated for various shoulder conditions. WOOS total score ranges from 0 to 100, with 0 representing the best shoulder condition and 100 representing the worst shoulder condition.
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Constant-Murley (CM) Score
The Constant-Murley (CM) Score is a commonly used score of shoulder function. CM scores range from 0 to 100, with a score of 0 indicating a worse shoulder function (i.e., worst outcome) and 100 indicating the best shoulder function (i.e., best outcome).
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
EQ-5D-3L Quality of Life Score
The EuroQol 5-Dimension 3-Level (EQ-5D-3L) Quality of Life Score ranges on a scale of 0 to 1, with 0 indicating a worse health condition (i.e., worst outcome) and 1 indicating the best health condition (i.e., best outcome).
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
EQ-5D-3L VAS Score
The EuroQol 5-Dimension 3-Level (EQ-5D-3L) Visual Analog Scale (VAS) Score ranges on a scale of 0 to 100, with 0 indicating a worse health condition (i.e., worst outcome) and 100 indicating the best health condition (i.e., best outcome).
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startAug 2010
- Primary completionSep 2023
- Study completionSep 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
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie Lankiewicz, Study director, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405208
- Sponsor's protocol ID
- CP-HRA-002
- Acronym
- CHRA
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2014
- Last updated
- 24 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
- ClinicalTrials.gov ID
- NCT02405208
- Acronym / sponsor ID
- CHRA / CP-HRA-002
- Conditions
- Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010 (actual)
- Primary completion
- Sep 2023 (actual)
- Study completion
- Sep 2023 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Posted 24 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement.
Detailed description
This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty.
The investigation will be conducted by up to 10 International surgeons experienced in HRA. 387 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary cohort | – | Device: PyroTITAN HRAPrimary cohort will receive the PyroTITAN HRA device |
Who may qualify
- Ages
- 21 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 (8 listed)
- Patients selected for inclusion will present for primary shoulder surface replacement or arthroplasty with any of the following diagnoses:
- 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 21 years of age and skeletally mature at the time of surgery.
Key exclusion criteria (17 listed)
- Have destruction of the proximal humerus to preclude rigid fixation of the humeral component.
- Insufficient bone quality as determined by intra-operative evaluation.
- Have arthritis with defective rotator cuff.
- Have had a failed rotator cuff surgery.
- Have 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 using the PyroTITAN HRA device | Device | Primary cohort |
Primary outcome
Device Survival
Time frame: up to 117 months
Clinical success was determined by the percentage of shoulders with device survival. Survival of the device was measured by the Kaplan-Meier survival estimate with survival defined as all the following: * Device remained implanted * Absence of device-related complications requiring surgical replacement, removal, or augmentation of components * Freedom from chronic dislocation
8 secondary outcomes
Radiographic Success
Time frame: 2 years, 3 years, 4 years, 5 years, 8 years and 10 years
ASES Score
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Visual Analog Scale (VAS) Pain Score
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Visual Analog Scale (VAS) Satisfaction Score
Time frame: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
The Western Ontario of the Shoulder Index (WOOS) Score
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Constant-Murley (CM) Score
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
EQ-5D-3L Quality of Life Score
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
EQ-5D-3L VAS Score
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- 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.
Julie Lankiewicz study director
Smith & Nephew, Inc.
5 sites in 4 countries: 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 5 sites in 4 countries.
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 8 inclusion and 17 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 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, France, Sweden, United Kingdom. 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 24 Dec 2025). 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 (time frame: up to 117 months). 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 24 Dec 2025.