A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing

NCT02405208 | Completed Results

• 1 other identifier: CP-HRA-002
• Study Type: observational
• Target: 156
• Locations: 4 countries
• Sites: 5

Brief Summary

This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement.

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

• Device Survival

  Clinical success was determined by the percentage of shoulders with device survival. Survival of the device was measured by the Kaplan-Meier survival estimate with survival defined as all the following: * Device remained implanted * Absence of device-related complications requiring surgical replacement, removal, or augmentation of components * Freedom from chronic dislocation

  up to 117 months

Secondary Outcomes (8)

• Radiographic Success

  2 years, 3 years, 4 years, 5 years, 8 years and 10 years

• ASES Score

  Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

• Visual Analog Scale (VAS) Pain Score

  Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

• Visual Analog Scale (VAS) Satisfaction Score

  3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

• The Western Ontario of the Shoulder Index (WOOS) Score

  Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

Study Arms (1)

Primary cohort

Primary cohort will receive the PyroTITAN HRA device

Device: PyroTITAN HRA

Interventions

PyroTITAN HRA DEVICE

Humeral resurfacing using the PyroTITAN HRA device

Primary cohort

Eligibility Criteria

• Age: 21 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:

• Osteoarthritis
• Rheumatoid / Inflammatory Arthritis
• Post-traumatic arthritis.
• Focal and large (Hill-Sachs) osteochondral defects.
• 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 21 years of age and skeletally mature at the time of surgery.

You may not qualify if:

• Have destruction of the proximal humerus to preclude rigid fixation of the humeral component.
• Insufficient bone quality as determined by intra-operative evaluation.
• Have arthritis with defective rotator cuff.
• Have had a failed rotator cuff surgery.
• Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
• Have evidence of active infection.
• Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexis 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 skeletally immature.
• Have a known allergic reaction to pyrocarbon.
• Have 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.
• Are currently participating in another clinical study.
• Have known, active metastatic or neoplastic disease.
• Are taking \> 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
• Are under 21 years of age or over 75.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (5)

Brisbane Hand & Upper Limb Clinic

Brisbane, Queensland, 4001, Australia

Location

Barwon Health

Geelong, Victoria, 3220, Australia

Location

Institut Nices

Nice, 06000, France

Location

Danderyd Hospital

Stockholm, S-182 88, Sweden

Location

Wrightington Hospital

Wigan, Wrightington, WN6 9EP, United Kingdom

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Limitations and Caveats

The study was managed by Ascension Orthopedics, Inc prior to Smith+Nephew Inc. (Memphis) becoming the sponsor in January 2021. This study was not designed nor controlled/monitored by Smith+Nephew Inc. (Memphis), except for the final follow-up phase. The data reported is based on the data available since the time of Smith+Nephew's acquisition of Ascension Orthopedics, Inc.

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

+44 7811 407089

Study Officials

• Julie Lankiewicz

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: April 1, 2015
• Study Start: August 1, 2010
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2024-11

Locations

FR (1); GB (1); AU (2); SE (1)