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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02983292




Registration number
NCT02983292
Ethics application status
Date submitted
1/12/2016
Date registered
6/12/2016
Date last updated
6/11/2020

Titles & IDs
Public title
PyroTITAN Humeral Resurfacing Arthroplasty (HRA)
Scientific 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
Secondary ID [1] 0 0
T-HRA-003
Universal Trial Number (UTN)
Trial acronym
HRA
Linked study record

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

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

Treatment: Devices: PyroTITAN™ HRA
Humeral Resurfacing

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

Outcomes
Primary outcome [1] 0 0
Device survival - Assessment of device survival at the two year time-point
Timepoint [1] 0 0
October 2020
Secondary outcome [1] 0 0
Device related adverse events - Absence of complications (device related Adverse Events), and post-op procedures on the affected joint including additional revision surgeries at 2-year and 5-year time-points.
Timepoint [1] 0 0
October 2020
Secondary outcome [2] 0 0
Device functionality - Assessment of the functionality of the PyroTITAN™ HRA Shoulder System through clinical assessments at 2-year and 5-year time-points.
Timepoint [2] 0 0
October 2020

Eligibility
Key inclusion criteria
Patients of either sex will be included, if they:

1. Present (prospective cohort) or presented (retrospective cohort) for primary shoulder
surface replacement or arthroplasty with any of the following diagnoses:

1. Osteoarthritis

2. Rheumatoid / Inflammatory Arthritis

3. Post-traumatic arthritis.

4. Focal and large (Hill-Sachs) osteochondral defects.

2. 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.

3. Subject is able to or capable of providing consent to participate in the clinical
investigation.

4. Subject agrees to comply with this protocol, including participating in required
follow-up visits at the investigations site and completing study questionnaires.

5. Subject is at least 18 years of age and skeletally mature at the time of surgery.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from participation if they:

1. Has/had destruction of the proximal humerus to preclude rigid fixation of the humeral
component.

2. Has/had insufficient bone quality as determined by intra- operative evaluation.

3. Has/had arthritis with defective rotator cuff.

4. Has/had had a failed rotator cuff surgery.

5. Has/had loss of musculature, neuromuscular compromise or vascular deficiency in the
affected limb rendering the procedure unjustified.

6. Has/had evidence of active infection.

7. Present/presented with a condition of neuromuscular compromise of the shoulder (e.g.,
neuropathic joints or brachioplexus 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/were skeletally immature.

10. Has/had a known allergic reaction to PyroCarbon.

11. 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.

12. Has/had known, active metastatic or neoplastic disease.

13. Are/were taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers,
within 3 months prior to surgery.

14. Are/were under 21 years of age or over 75.

15. Require/required glenoid replacement.

16. Retrospective patients cannot be enrolled if they are two year or greater out from the
index surgery.

17. Women, who are pregnant or are planning to become pregnant.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The Brisbane Hand and Upper Limb Research Institute - Brisbane
Recruitment postcode(s) [1] 0 0
4001 - Brisbane

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

Ethics approval
Ethics application status

Summary
Brief 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 devices with sub-standard
mechanical integrity.
Trial website
https://clinicaltrials.gov/show/NCT02983292
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew J Tummon
Address 0 0
Integra LifeSciences Corporation
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