Clinical trial NCT02983292: PyroTITAN Humeral Resurfacing Arthroplasty (HRA)
Official title: A Clinical and Radiological Study to Evaluate the Safety and Efficacy of the PyroTITAN Humeral Resurfacing Arthroplasty (HRA) Device in a New Cohort of Patients After Product Re-Release
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-06
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who require humeral head resurfacing arthroplasty.

Brief 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.

Detailed description: 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. The results will be compared to data collected in a prior study conducted before implementing the new proof test. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected retrospectively and prospectively for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty.

137 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for up to 60 months.

Eligibility criteria: Inclusion Criteria:

Patients of either sex will be included, if they:

1. Present (prospective cohort) or presented (retrospective cohort) for primary shoulder surface replacement or arthroplasty with any of the following diagnoses:

   1. Osteoarthritis
   2. Rheumatoid / Inflammatory Arthritis
   3. Post-traumatic arthritis.
   4. Focal and large (Hill-Sachs) osteochondral defects.
2. 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.
3. Subject is able to or capable of providing consent to participate in the clinical investigation.
4. Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires.
5. 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:

1. Has/had destruction of the proximal humerus to preclude rigid fixation of the humeral component.
2. Has/had insufficient bone quality as determined by intra- operative evaluation.
3. Has/had arthritis with defective rotator cuff.
4. Has/had had a failed rotator cuff surgery.
5. Has/had loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
6. Has/had evidence of active infection.
7. Present/presented with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexus 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/were skeletally immature.
10. Has/had a known allergic reaction to PyroCarbon.
11. 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.
12. Has/had known, active metastatic or neoplastic disease.
13. Are/were taking \> 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
14. Are/were under 21 years of age or over 75.
15. Require/required glenoid replacement.
16. Retrospective patients cannot be enrolled if they are two year or greater out from the index surgery.
17. Women, who are pregnant or are planning to become pregnant.

Primary outcomes:
measure: Device Survival: Kaplan-Meir Estimate
timeFrame: 2 years
Secondary outcomes:
measure: Number of Participants With Device-Related Adverse Events
timeFrame: Post-operatively to 5-Years
measure: Cumulative Device Success
timeFrame: 2-Years and 5-Years
measure: Cumulative Device Survival
timeFrame: 2-Years and 5-Years
measure: Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score
timeFrame: Baseline, 2-Years and 5-Years
measure: Device Functionality: Visual Analog Scale (VAS) - Pain
timeFrame: Baseline, 2-Years and 5-Years
measure: Device Functionality: Visual Analog Scale (VAS) - Satisfaction
timeFrame: Baseline, 2-Years and 5-Years
measure: Device Functionality: Western Ontario Osteoarthritis Score (WOOS)
timeFrame: Baseline, 2-Years and 5-Years
measure: Device Functionality: QuickDASH Outcome Measure
timeFrame: Baseline, 2-Years and 5-Years
measure: Device Functionality: Constant Murley Score (CMS)
timeFrame: Baseline, 2-Years and 5-Years
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: The Brisbane Hand and Upper Limb Research Institute
state: Queensland
Study officials:
affiliation: Smith & Nephew, Inc.
name: Belinda Larson
role: STUDY_DIRECTOR
References: