NCT02983292

Completed

PyroTITAN Humeral Resurfacing Arthroplasty (HRA)

Smith & Nephew, Inc.Source

Smith & Nephew, Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

T-HRA-003

Study Type

observational

Actual enrollment (reported)

137

Locations

1 country

Sites

1

Timeline

Study Start

October 2016

Actual (reported)

Primary Completion

February 8, 2023

Actual (reported)

Study Completion

February 8, 2023

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 137 participants
Study completion date: February 8, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2016
Actual (reported)
First Submitted
December 1, 2016
Actual (reported)
First Posted
December 6, 2016
Actual (reported)
Primary Completion
February 8, 2023
Actual (reported)
Study Completion
February 8, 2023
Actual (reported)
Results Posted
November 4, 2024
Actual (reported)

Last Updated: November 4, 2024
Status Verified: June 2024
Results QC Date: August 26, 2024
Last Update Submitted: August 26, 2024

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

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 Outcomes (9)

Number of Participants With Device-Related Adverse Events
Post-operatively to 5-Years
Cumulative Device Success
2-Years and 5-Years
Cumulative Device Survival
2-Years and 5-Years
Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score
Baseline, 2-Years and 5-Years
Device Functionality: Visual Analog Scale (VAS) - Pain
Baseline, 2-Years and 5-Years
+4 more secondary outcomes

Interventions

PyroTITAN™ HRADevice

Humeral Resurfacing

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Subjects who require humeral head resurfacing arthroplasty.

You may qualify if:

Patients of either sex will be included, if they:

Sponsors & Collaborators

Smith & Nephew, Inc.
Industrylead

Study Sites (1)

The Brisbane Hand and Upper Limb Research Institute

Brisbane, Queensland, 4001, Australia

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Results Point of Contact

Title: Dr. Manvendra Saxena
Organization: Senior Specialist-Clinical Study Management

Study Officials

Belinda Larson
Smith & Nephew, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

137 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: OTHER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 6, 2016

Study Start

October 2016

Actual (reported)

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Not ApplicableCompleted

NCT02305966

Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty

Phase 3Unknown

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

Osteoarthritis

Rheumatoid / Inflammatory Arthritis

Post-traumatic arthritis.

Focal and large (Hill-Sachs) osteochondral defects.

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.

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

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

Subject is at least 18 years of age and skeletally mature at the time of surgery.

You may not qualify if:

Patients will be excluded from participation if they:
Has/had destruction of the proximal humerus to preclude rigid fixation of the humeral component.
Has/had insufficient bone quality as determined by intra- operative evaluation.
Has/had arthritis with defective rotator cuff.
Has/had had a failed rotator cuff surgery.
Has/had loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
Has/had evidence of active infection.
Present/presented with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint).
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.
Are/were skeletally immature.
Has/had a known allergic reaction to PyroCarbon.
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.
Has/had known, active metastatic or neoplastic disease.
Are/were taking \> 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
Are/were under 21 years of age or over 75.
+3 more criteria

Contact the study team to confirm eligibility.

Primary Completion

February 8, 2023

Actual (reported)

Study Completion

February 8, 2023

Actual (reported)

Last Updated

November 4, 2024

Results First Posted

November 4, 2024

Record last verified: 2024-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02983292
Data provider: ClinicalTrials.gov
Source updated: 2024-11-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:50 UTC

Documents

Study Protocol
Protocol2017-08-18
Statistical Analysis Plan
SAP2023-03-10

Locations

AU(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations