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

Active, not recruiting

• Conditions: Arthritis
• Interventions: Device: PyroTITAN HRA

• Registration Number: NCT02405208
• Lead Sponsor: Smith & Nephew, Inc.

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.

Detailed Description

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. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty.

The investigation will be conducted by up to 10 International surgeons experienced in HRA. 387 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for 10 years.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-04-01
• Primary Completion: 2023-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. Patients selected for inclusion will present 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.

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

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

4. Subject is at least 21 years of age and skeletally mature at the time of surgery.

Exclusion Criteria

1. Have destruction of the proximal humerus to preclude rigid fixation of the humeral component.

2. Insufficient bone quality as determined by intra-operative evaluation.

3. Have arthritis with defective rotator cuff.

4. Have had a failed rotator cuff surgery.

5. Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.

6. Have evidence of active infection.

7. Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexis 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 skeletally immature.

10. Have a known allergic reaction to pyrocarbon.

11. 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.

12. Are currently participating in another clinical study.

13. Have known, active metastatic or neoplastic disease.

14. Are taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.

15. Are under 21 years of age or over 75.

    .

16. Require glenoid replacement (Glenoid Classification).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary cohort	PyroTITAN HRA	Primary cohort will receive the PyroTITAN HRA device

Primary Outcome Measures

Name	Time	Method
Device	2 Year, 5 Year, and 10 Years	Primary endpoint: absence of device related complications resulting in revision or removal of components.

Secondary Outcome Measures

Name	Time	Method
The WOOS score	2 years, 3 Years, 4 Years, 5 years, 8 Years, and 10 Years	The WOOS Score is a quality of life questionnaire that has been validated for various shoulder conditions.
Visual Analog Scale (VAS)	2 years, 3 Years, 4 Years, 5 years, 8 Years, and 10 Years	The Visual Analog Scale (VAS) form assesses pain, shoulder pain and satisfaction as it relates to the effected shoulder.
EQ 5D	2 years, 3 Years, 4 Years, 5 years, 8 Years, and 10 Years	The EQ-5D Questionnaire consists of information pertaining to the current health status of the patient at the time of evaluation.
The Constant Score	2 years, 3 Years, 4 Years, 5 years, 8 Years, and 10 Years	The Constant Score is a commonly used score of shoulder function.
Improvement in joint range of motion	2 years, 3 Years, 4 Years, 5 years, 8 Years, and 10 Years	Assesses the range of motion in the shoulder
ASES Score	2 years, 3 Years, 4 Years, 5 years, 8 Years, and 10 Years	The ASES Shoulder Score is a functional outcome tool that has been validated for various shoulder conditions
Number of participants with adverse events	2 years	to assess the safety of the device

Trial Locations

Locations (5)

Brisbane Hand & Upper Limb Clinic; 🇦🇺 Brisbane, Queensland, Australia

Institut Nices; 🇫🇷 Nice, France

Barwon Health; 🇦🇺 Geelong, Victoria, Australia

Danderyd Hospital; 🇸🇪 Stockholm, Sweden

Wrightington Hospital; 🇬🇧 Wigan, Wrightington, United Kingdom