Clinical trial NCT03168672: GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study
Official title: GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Post Traumatic Arthritis
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 171
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Post Market Clinical Follow Up (PMCF) study to monitor the safety and performance of the GLOBAL ICON stemless humeral component. The data gathered will be used to support post market surveillance of the device, and may potentially be used for additional market access purposes.

Detailed description: This study will be multi-centre and non-comparative. Subjects will be recruited and followed up at similar intervals to reflect the standard clinical practice and intended population for wider use of the device.

157 non-randomised subjects will be recruited from approximately 15 sites. A maximum of 30 subjects may be recruited from one site. More than one implanting surgeon may recruit subjects at each site as a designated sub-Investigator.

The primary objective of this PMCF study is to confirm device survivorship of the GLOBAL ICON stemless humeral component at 24 months post-operative.

The secondary objectives include the evaluation of clinical performance, radiographic performance and safety outcomes at 3, 12, 24, 60 and 120 months post-operatively.

Tertiary endpoints in the study will include a mean change from baseline for the Adjusted Constant-Murley Score, the Oxford Shoulder Score, the EQ-5D-5L dimension score and EQ-VAS scores. Radiographic evidence of aseptic loosening and periprosthetic fracture survivorship of the GLOBAL ICON stemless humeral component will be assessed.

Eligibility criteria: Inclusion Criteria:

Severely painful and/or severely disabled Non-Inflammatory Degenerative Joint Disease (NIDJD) resulting from osteoarthritis (OA) or post traumatic arthritis Patient is willing and able to complete the required post-operative schedule Patient has provided written Informed Consent to participate

Exclusion Criteria:

Subjects under the age of 21 or over the age of 80 on the day of consent Subjects who have not reached skeletal maturity, regardless of age Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the GLOBAL ICON stemless humeral components Bone that is too soft or porous to support the implant or that is too hard or brittle to allow for proper bone preparation and fixation, i.e osteoporosis or sclerotic bone, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid Fractures of the proximal humerus that could compromise the fixation of the GLOBAL ICON stemless humeral components Subjects who have undergone previous treatment on the study shoulder that may compromise fixation of the GLOBAL ICON stemless humeral components Revision of a failed hemi, total or reverse shoulder arthroplasty Active local or systemic infection Absent, irreparable or nonfunctional rotator cuff or other essential muscles Subject is receiving, or is scheduled to receive, treatment that the Investigator considers could affect bone quality, such as chemotherapy or high dose corticosteroids Subjects who, at the point of enrolment, already have a GLOBAL ICON shoulder replacement or are scheduled to receive, a contralateral shoulder replacement device Subjects who are known to be pregnant or breastfeeding Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes Subjects with a known medical condition that the Investigator believes would impact the study outcomes (including, but not limited to osteomyelitis, Paget's disease, neuropathies such as Charcot's disease, metastatic or neoplastic disorders) Known polyethylene and/or metal sensitivity or allergy

Primary outcomes:
measure: Adjusted Constant-Murley Shoulder Assessment Score.
timeFrame: 24 Months
measure: Continuous Radiolucent Line
timeFrame: 24 months
measure: Kaplan Meier Survivorship
timeFrame: 24 months
measure: Device-related Serious Adverse Events
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
city: Bad Rappenau
country: Germany
facility: Vulpius Klinik
city: Hannover
country: Germany
facility: Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift
city: Ravensburg
country: Germany
facility: Sportklinik Ravensburg
city: Emmen
country: Netherlands
facility: Treant Hospital
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Hilversum
country: Netherlands
facility: Tergooi Hospital
city: Aberdeen
country: United Kingdom
facility: Woodend Hospital
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth Hospital
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Nottingham
country: United Kingdom
facility: City Hospital
Study officials:
References: