N/A
N=156
A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02405208 ↗Enrolled (actual)
156
Serious AEs
32.7%
Results posted
Dec 2025
Primary outcome: Primary: Device Survival — 85.97 percentage of shoulders
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PyroTITAN HRA (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Survival |
85.97 | — |
| SECONDARY Radiographic Success |
— | — |
| SECONDARY ASES Score |
36.2; 66.0; 78.3; 82.5; 86.0; 85.7 | — |
| SECONDARY Visual Analog Scale (VAS) Pain Score |
64.1; 24.2; 18.1; 15.5; 13.2; 15.5 | — |
| SECONDARY Visual Analog Scale (VAS) Satisfaction Score |
75.8; 81.1; 84.0; 85.6; 85.6; 86.3 | — |
| SECONDARY The Western Ontario of the Shoulder Index (WOOS) Score |
65.1; 34.3; 22.2; 18.6; 15.3; 15.2 | — |
| SECONDARY Constant-Murley (CM) Score |
39.4; 57.3; 72.5; 78.8; 82.5; 81.5 | — |
| SECONDARY EQ-5D-3L Quality of Life Score |
0.759; 0.824; 0.860; 0.886; 0.870; 0.883 | — |
| SECONDARY EQ-5D-3L VAS Score |
61.9; 69.0; 71.3; 75.7; 75.2; 70.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- 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.
Exclusion Criteria
- 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.
.
- Require glenoid replacement (Glenoid Classification).
Data sourced from ClinicalTrials.gov (NCT02405208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.