PyroTITAN Humeral Resurfacing Arthroplasty (HRA)

Arthritis Clinical Trial

— HRA  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02983292
• Other study ID #: T-HRA-003
• Status: Active, not recruiting
• Start date: October 2016
• Est. completion date: November 29, 2024

Study information

• Verified date: June 2024
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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. The results will be compared to data collected in a prior study conducted before implementing the new proof test. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected retrospectively and prospectively for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty. 137 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for up to 60 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 137
• Est. completion date: November 29, 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. 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.

Related Conditions & MeSH terms

• Arthritis

Intervention

Device:
• PyroTITAN™ HRA
Humeral Resurfacing

Locations

Country	Name	City	State
Australia	The Brisbane Hand and Upper Limb Research Institute	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device survival	Assessment of device survival at the two year time-point	October 2020
Secondary	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.	October 2020
Secondary	Device functionality	Assessment of the functionality of the PyroTITAN™ HRA Shoulder System through clinical assessments at 2-year and 5-year time-points.	October 2020