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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02405208




Registration number
NCT02405208
Ethics application status
Date submitted
4/11/2014
Date registered
1/04/2015
Date last updated
8/08/2019

Titles & IDs
Public title
A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
Scientific title
A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
Secondary ID [1] 0 0
CP-HRA-002
Universal Trial Number (UTN)
Trial acronym
CHRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - PyroTITAN HRA

Primary cohort - Primary cohort will receive the PyroTITAN HRA device


Treatment: Devices: PyroTITAN HRA
Humeral resurfacing using the PyroTITAN HRA device

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ASES - The ASES Shoulder Score is a functional outcome tool that has been validated for various shoulder conditions
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
The WOOS score - The WOOS Score is a quality of life questionnaire that has been validated for various shoulder conditions.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Visual Analog Scale (VAS) - The Visual Analog Scale (VAS) form assesses pain, shoulder pain and satisfaction as it relates to the effected shoulder.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
EQ 5D - The EQ-5D Questionnaire consists of information pertaining to the current health status of the patient at the time of evaluation.
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
The Constant Score - The Constant Score is a commonly used score of shoulder function.
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Improvement in joint range of motion - Assesses the range of motion in the shoulder
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Number of participants with adverse events - to assess the safety of the device
Timepoint [7] 0 0
2 years

Eligibility
Key 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.
Minimum age
21 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Brisbane Hand & Upper Limb Clinic - Brisbane
Recruitment hospital [2] 0 0
Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
4001 - Brisbane
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Nice
Country [2] 0 0
Sweden
State/province [2] 0 0
Stockholm
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Wrightington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Integra LifeSciences Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02405208
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Tummon
Address 0 0
Integra LifeSciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications