PyroTITAN Humeral Resurfacing Arthroplasty (HRA)

NCT ID: NCT02983292

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 137 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2023-02-08

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.

Detailed 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.

Conditions

Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

PyroTITAN™ HRA

Humeral Resurfacing

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Belinda Larson

Role: STUDY_DIRECTOR

Smith & Nephew, Inc.

Locations

The Brisbane Hand and Upper Limb Research Institute

Brisbane, Queensland, Australia

Countries

Australia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

T-HRA-003

Identifier Type: -

Identifier Source: org_study_id