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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
Scientific title
A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - PyroTITAN HRA

Primary cohort - Primary cohort will receive the PyroTITAN HRA device

Treatment: Devices: PyroTITAN HRA
Humeral resurfacing using the PyroTITAN HRA device

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
ASES - The ASES Shoulder Score is a functional outcome tool that has been validated for various shoulder conditions
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
The WOOS score - The WOOS Score is a quality of life questionnaire that has been validated for various shoulder conditions.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Visual Analog Scale (VAS) - The Visual Analog Scale (VAS) form assesses pain, shoulder pain and satisfaction as it relates to the effected shoulder.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
EQ 5D - The EQ-5D Questionnaire consists of information pertaining to the current health status of the patient at the time of evaluation.
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
The Constant Score - The Constant Score is a commonly used score of shoulder function.
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Improvement in joint range of motion - Assesses the range of motion in the shoulder
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
No evidence of device failure on X-rays - true anterior-posterior in the scapular plane, internal and external rotation, axial lateral and an axillary lateral view.
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Number of participants with adverse events - to assess the safety of the device
Timepoint [7] 0 0
2 years

Key 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

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.
Minimum age
21 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Have destruction of the proximal humerus to preclude rigid fixation of the humeral

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 design
Statistical methods / analysis

Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Brisbane Hand & Upper Limb Clinic - Brisbane
Recruitment hospital [2] 0 0
Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
4001 - Brisbane
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
State/province [1] 0 0
Country [2] 0 0
State/province [2] 0 0
Country [3] 0 0
United Kingdom
State/province [3] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Integra LifeSciences Corporation

Ethics approval
Ethics application status

Brief 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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Andrew Tummon
Address 0 0
Integra LifeSciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications