PyroTITAN Humeral Resurfacing Arthroplasty (HRA)

NCT02983292 | Completed Results

• 1 other identifier: T-HRA-003
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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.

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

Interventions

PyroTITAN™ HRA DEVICE

Humeral Resurfacing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who require humeral head resurfacing arthroplasty.

You may qualify if:

• Patients of either sex will be included, if they:
• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

The Brisbane Hand and Upper Limb Research Institute

Brisbane, Queensland, 4001, Australia

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Results Point of Contact

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

manvendra.saxena@smith-nephew.com

+61 455 870 175

Study Officials

• Belinda Larson

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 1, 2016
• Primary Completion: February 8, 2023
• Study Completion: February 8, 2023
• Last Updated: November 4, 2024
• Results First Posted: November 4, 2024

Record last verified: 2024-06

Locations

AU (1)