A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing (CHRA)

December 5, 2025 updated by: Smith & Nephew, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4001
        • Brisbane Hand & Upper Limb Clinic
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Barwon Health
  • France
      • Nice, France, 06000
        • Institut Nices
  • Sweden
      • Stockholm, Sweden, S-182 88
        • Danderyd Hospital
  • United Kingdom
    • Wrightington
      • Wigan, Wrightington, United Kingdom, WN6 9EP
        • Wrightington Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who require humeral head resurfacing arthroplasty.

Description

Inclusion Criteria:

  1. 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.
  2. Subject is able to or capable of providing consent to participate in the clinical investigation.
  3. Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires.
  4. Subject is at least 21 years of age and skeletally mature at the time of surgery.

Exclusion Criteria:

  1. Have destruction of the proximal humerus to preclude rigid fixation of the humeral component.
  2. Insufficient bone quality as determined by intra-operative evaluation.
  3. Have arthritis with defective rotator cuff.
  4. Have had a failed rotator cuff surgery.
  5. Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
  6. Have evidence of active infection.
  7. Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexis 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 skeletally immature.
  10. Have a known allergic reaction to pyrocarbon.
  11. 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.
  12. Are currently participating in another clinical study.
  13. Have known, active metastatic or neoplastic disease.
  14. Are taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.

  15. Are under 21 years of age or over 75.

    .

  16. Require glenoid replacement (Glenoid Classification).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Primary cohort
Primary cohort will receive the PyroTITAN HRA device
Device: PyroTITAN HRA
Humeral resurfacing using the PyroTITAN HRA device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to 117 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radiographic Success
Time Frame: 2 years, 3 years, 4 years, 5 years, 8 years and 10 years

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
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
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.
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
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).
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
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).
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
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.
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
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).
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
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).
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
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).
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Smith & Nephew, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Julie Lankiewicz, Smith & Nephew, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP-HRA-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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