PyroTITAN Humeral Resurfacing Arthroplasty (HRA)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02983292

Acronym

HRA

Enrollment

137

Registered

2016-12-06

Start date

2016-10-31

Completion date

2023-02-08

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis

Brief summary

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.

Interventions

DEVICEPyroTITAN™ HRA

Humeral Resurfacing

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Device Survival: Kaplan-Meir Estimate	2 years	Device survival was defined as the absence of device fracture at the two year time-point. Percentage of participants with survival of the device estimated using the Kaplan-Meier method.

Secondary

Measure	Time frame	Description
Cumulative Device Success	2-Years and 5-Years	Device success was defined as the absence of device fracture over time. Cumulative device success was determined by the percentage of participants with no device fractures by the two year & five year time-points.
Cumulative Device Survival	2-Years and 5-Years	Device survival was defined as the absence of device revision over time. Cumulative device survival was determined by the percentage of participants with no device revisions by the two year & five year time-points.
Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score	Baseline, 2-Years and 5-Years	ASES scores range from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition.
Device Functionality: Visual Analog Scale (VAS) - Pain	Baseline, 2-Years and 5-Years	The VAS Pain score range was from 0 to 100, with 0 representing no pain and 100 representing the worse possible pain.
Number of Participants With Device-Related Adverse Events	Post-operatively to 5-Years	Count of participants with device-related Non-Serious & Serious Adverse Events were the event was related to device use (e.g., component breakage) as determined by investigator assessment.
Device Functionality: Western Ontario Osteoarthritis Score (WOOS)	Baseline, 2-Years and 5-Years	The WOOS score was based on 19 questions ranging from 0 to 100 with 0 being the best result and 100 being the worst result. A lower score indicated a better outcome.
Device Functionality: QuickDASH Outcome Measure	Baseline, 2-Years and 5-Years	The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) score ranged from 0 (no disability) to 100 (most severe disability) based on 11 questions scored 1 to 5 each (for disability/symptoms) and 4 questions scored 1 to 5 each (for performance/sport/work). A lower score indicates a better outcome.
Device Functionality: Constant Murley Score (CMS)	Baseline, 2-Years and 5-Years	The Constant Murley Score (CMS) is a 100-point scale composed of individual parameters. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and Range of Motion (ROM) (40 points). Subscales are combined to indicate a total CMS score. The total CMS score ranges from 0 to 100 points, with higher scores indicating a better outcome.
Device Functionality: Visual Analog Scale (VAS) - Satisfaction	Baseline, 2-Years and 5-Years	The VAS Satisfaction score range was from 0 to 100, with 0 representing the worst result and 100 representing the best result.

Countries

Australia

Participant flow

Recruitment details

Participants were enrolled in the study at one (1) site in Australia and participated between 24 Oct 2016 to 08 Feb 2023.

Pre-assignment details

Overall, 137 participants were enrolled in the study, and fifty-two (52) participants discontinued from the study before completion.

Participants by arm

Arm	Count
PyroTITAN™ HRA Shoulder System Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System	137
Total	137

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	1
Overall Study	Lost to Follow-up	3
Overall Study	Participant did not return due to COVID-19 related lockdown	30
Overall Study	Participant failed to return for follow-up visits	6
Overall Study	Participant relocation	1
Overall Study	Participant unwell & cannot travel	2
Overall Study	Participant withdrew consent	2
Overall Study	Revision	7

Baseline characteristics

Characteristic	PyroTITAN™ HRA Shoulder System	—
Age, Continuous	57.0 years STANDARD_DEVIATION 12.7	—
Body Mass Index (BMI)	30.1 kg/m^2 STANDARD_DEVIATION 5	—
Dominant Side Left	14 Participants	—
Dominant Side Missing	0 Participants	—
Dominant Side Right	123 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Australia	137 participants	—
Sex: Female, Male Female	100 Participants	—
Sex: Female, Male Male	37 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 137
other Total, other adverse events	12 / 137
serious Total, serious adverse events	47 / 137

Outcome results

Primary

Device Survival: Kaplan-Meir Estimate

Device survival was defined as the absence of device fracture at the two year time-point. Percentage of participants with survival of the device estimated using the Kaplan-Meier method.

Time frame: 2 years