PyroTITAN Humeral Resurfacing Arthroplasty (HRA) (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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis
• Intervention / Treatment: Device: PyroTITAN™ HRA

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.

• Study Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4001
      • The Brisbane Hand and Upper Limb Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who require humeral head resurfacing arthroplasty.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Device-Related Adverse Events	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.	Post-operatively to 5-Years
Cumulative Device Success	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.	2-Years and 5-Years
Cumulative Device Survival	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.	2-Years and 5-Years
Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score	ASES scores range from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition.	Baseline, 2-Years and 5-Years
Device Functionality: Visual Analog Scale (VAS) - Pain	The VAS Pain score range was from 0 to 100, with 0 representing no pain and 100 representing the worse possible pain.	Baseline, 2-Years and 5-Years
Device Functionality: Visual Analog Scale (VAS) - Satisfaction	The VAS Satisfaction score range was from 0 to 100, with 0 representing the worst result and 100 representing the best result.	Baseline, 2-Years and 5-Years
Device Functionality: Western Ontario Osteoarthritis Score (WOOS)	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.	Baseline, 2-Years and 5-Years
Device Functionality: QuickDASH Outcome Measure	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.	Baseline, 2-Years and 5-Years
Device Functionality: Constant Murley Score (CMS)	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.	Baseline, 2-Years and 5-Years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Director: Belinda Larson, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): February 8, 2023

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (Estimated): December 6, 2016

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Arthritis
• Other Study ID Numbers: T-HRA-003