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

Arthritis Clinical Trial

— CHRA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02405208
• Other study ID #: CP-HRA-002
• Status: Active, not recruiting
• Start date: May 2010
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 142
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis

Intervention

Device:
• PyroTITAN HRA
Humeral resurfacing using the PyroTITAN HRA device

Locations

Country	Name	City	State
Australia	Brisbane Hand & Upper Limb Clinic	Brisbane	Queensland
Australia	Barwon Health	Geelong	Victoria
France	Institut Nices	Nice
Sweden	Danderyd Hospital	Stockholm
United Kingdom	Wrightington Hospital	Wigan	Wrightington

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

Australia,  France,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASES	The ASES Shoulder Score is a functional outcome tool that has been validated for various shoulder conditions	2 years
Secondary	The WOOS score	The WOOS Score is a quality of life questionnaire that has been validated for various shoulder conditions.	2 years
Secondary	Visual Analog Scale (VAS)	The Visual Analog Scale (VAS) form assesses pain, shoulder pain and satisfaction as it relates to the effected shoulder.	2 years
Secondary	EQ 5D	The EQ-5D Questionnaire consists of information pertaining to the current health status of the patient at the time of evaluation.	2 years
Secondary	The Constant Score	The Constant Score is a commonly used score of shoulder function.	2 years
Secondary	Improvement in joint range of motion	Assesses the range of motion in the shoulder	2 years
Secondary	No evidence of device failure on X-rays	true anterior-posterior in the scapular plane, internal and external rotation, axial lateral and an axillary lateral view.	2 years
Secondary	Number of participants with adverse events	to assess the safety of the device	2 years