Clinical trial NCT02405208: A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
Official title: A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arthritis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-01
Enrollment: 142
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who require humeral head resurfacing arthroplasty.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Device
timeFrame: 2 Year, 5 Year, and 10 Years
Secondary outcomes:
measure: The WOOS score
timeFrame: 2 years, 3 Years, 4 Years, 5 years, 8 Years, and 10 Years
measure: Visual Analog Scale (VAS)
timeFrame: 2 years, 3 Years, 4 Years, 5 years, 8 Years, and 10 Years
measure: EQ 5D
timeFrame: 2 years, 3 Years, 4 Years, 5 years, 8 Years, and 10 Years
measure: The Constant Score
timeFrame: 2 years, 3 Years, 4 Years, 5 years, 8 Years, and 10 Years
measure: Improvement in joint range of motion
timeFrame: 2 years, 3 Years, 4 Years, 5 years, 8 Years, and 10 Years
measure: ASES Score
timeFrame: 2 years, 3 Years, 4 Years, 5 years, 8 Years, and 10 Years
measure: Number of participants with adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Brisbane Hand & Upper Limb Clinic
state: Queensland
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Nice
country: France
facility: Institut Nices
city: Stockholm
country: Sweden
facility: Danderyd Hospital
city: Wigan
country: United Kingdom
facility: Wrightington Hospital
state: Wrightington
Study officials:
affiliation: Smith & Nephew, Inc.
name: Julie Lankiewicz
role: STUDY_DIRECTOR
References: