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

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: Completed
• Conditions: Arthritis
• Intervention / Treatment: Device: PyroTITAN HRA

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: Observational
• Enrollment (Actual): 156

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	up to 117 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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).	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).	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.	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).	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).	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).	Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Director: Julie Lankiewicz, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2010
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: November 4, 2014
• First Submitted That Met QC Criteria: March 27, 2015
• First Posted (Estimated): April 1, 2015

Study Record Updates

• Last Update Posted (Estimated): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Arthritis
• Other Study ID Numbers: CP-HRA-002