N/A
N=137
PyroTITAN Humeral Resurfacing Arthroplasty (HRA)
Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02983292 ↗Enrolled (actual)
137
Serious AEs
34.3%
Results posted
Nov 2024
Primary outcome: Primary: Device Survival: Kaplan-Meir Estimate — 98.47 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PyroTITAN™ HRA (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Survival: Kaplan-Meir Estimate |
98.47 | — |
| SECONDARY Number of Participants With Device-Related Adverse Events |
6; 6 | — |
| SECONDARY Cumulative Device Success |
98.5; 97.5 | — |
| SECONDARY Cumulative Device Survival |
96.24; 94.17 | — |
| SECONDARY Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score |
31.1; 83.7; 88.1 | — |
| SECONDARY Device Functionality: Visual Analog Scale (VAS) - Pain |
66; 12.4; 9.5 | — |
| SECONDARY Device Functionality: Visual Analog Scale (VAS) - Satisfaction |
15.6; 89.6; 92.5 | — |
| SECONDARY Device Functionality: Western Ontario Osteoarthritis Score (WOOS) |
66.7; 14.2; 11.6 | — |
| SECONDARY Device Functionality: QuickDASH Outcome Measure |
49.5; 15.5; 14.5 | — |
| SECONDARY Device Functionality: Constant Murley Score (CMS) |
50.7; 79.9; 83.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
- Require/required glenoid replacement.
- Retrospective patients cannot be enrolled if they are two year or greater out from the index surgery.
- Women, who are pregnant or are planning to become pregnant.
Data sourced from ClinicalTrials.gov (NCT02983292). 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.