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…
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Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint in this study is composite success at 24 months if each of
the following criteria is met:
* Radiographs indicate that there is no continuous radiolucent line (RLL)
around the GLOBAL ICON stemless humeral component, with continuous RLL defined
as a radiolucent line > 1mm in all five zones of either AP or Axillary views
* The adjusted Constant-Murley score is greater than 85, with the adjustment
based on the method of Constant (Katolik et al, 2005)
* No GLOBAL ICON humeral component has been removed for any reason
* There have been no device-related serious adverse events
Secondary outcome
Secondary endpoints in the study will include the following:
* Mean adjusted Constant-Murley Score at baseline and 3, 12, 24, 60 and 120
months post-operative
* Mean Oxford Shoulder Score at baseline and 3, 12, 24, 60 and 120 months
post-operative
* Mean EQ-5D-5L Scores by dimension and EQ-VAS, at baseline and 3, 12, 24, 60,
and 120 months post-operative
* Radiographic evidence of aseptic loosening of the GLOBAL ICON stemless
humeral component immediate post-operative and 3, 12, 24, 60 and 120 months
post-operative
Tertiary endpoints in the study will include the following:
* Mean change from baseline for the adjusted Constant-Murley Score at 3, 12,
24, 60 and 120 months post-operative
* Mean change from baseline for the Oxford Shoulder Score at 3, 12, 24, 60 and
120 months post-operative
* Mean change from baseline for EQ-5D-5L dimension score and EQ-VAS scores at
3, 12, 24, 60 and 120 months post-operative
* Periprosthetic fracture survivorship of the GLOBAL ICON stemless humeral
component at 24, 60 and 120 months post-operative
The safety endpoints are:
* Overall survivorship of the GLOBAL ICON stemless humeral component
survivorship at 24, 60 and 120 months post-operative, where the device is
deemed to be surviving if no components (anchor plate and humeral head) have
been removed for any reason
* The type and frequency of all adverse events (AEs) in this study will be
summarised, with distinction of serious AEs, operative and device related AEs.
Background summary
The current gold standard of shoulder arthroplasty uses a stemmed implant in
the humerus as part of a hemi or total joint replacement. Shoulder resurfacing
was the first attempt to address opportunities for shoulder arthroplasty such
as bone conservation; however, the procedure is technically demanding and does
not allow for anatomic reconstruction. More recently, stemless shoulder devices
have been in use, where the implant is independent of the humeral canal
allowing the humeral head to be replaced in the optimal anatomic position.
Stemless implants also have the potential to provide increased procedural
efficiency through simplified instrumentation and implant selection, and to
conserve bone for future revision operations.
GLOBAL ICON is a stemless shoulder system, for use in total shoulder
arthroplasty in patients with osteoarthritis and post traumatic arthritis. It
is similar in design and intended use to other stemless shoulder prostheses
which are currently available and in clinical use.
The GLOBAL ICON stemless humeral component is intended to replace the proximal
humeral head in total shoulder arthroplasty. The GLOBAL ICON stemless humeral
component construct includes a Humeral Head and an Anchor Plate, for
articulation with the glenoid component and for fixation into the resected
proximal humerus, respectively. The system is bone conserving relative to
stemmed arthroplasty; it does not violate the humeral canal allowing surgeons
to properly position the component with fewer surgical steps. The GLOBAL ICON
implants were designed by leveraging the fact that the epiphyseal structures
can be characterized by a sphere and by constraining the design of the
construct within this sphere.
The GLOBAL ICON stemless humeral component has received CE marking following
demonstration that is it safe and effective by a systematic review of the
literature available on stemless shoulder devices
Study objective
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.
Study design
This is a prospective, multi-centre, non-comparative, uncontrolled post market
clinical follow up study to evaluate the short term survivorship, safety and
effectiveness of the GLOBAL ICON stemless shoulder component using clinical,
patient and radiographic outcomes.
157 non-randomised subjects will be recruited from approximately 20 sites and
followed up at similar intervals to reflect the standard clinical practice and
intended population for wider use of the device.
Study burden and risks
Any surgical procedure poses a potential risk and the procedures undertaken as
part of this clinical investigation are no exception. There are known risks
associated with the method of anaesthesia (general, epidural, local). In
addition to these there are risks associated with a surgical procedure that
involves a device. The risks that are associated with the study devices are
similar to those of any total shoulder arthroplasty.
As specified in the Instructions For Use (IFU) (Exhibit C and included in the
implant packaging), the following are generally the most frequently encountered
adverse events and complications in total shoulder arthroplasty. Some of the
identified risks are not directly applicable to this study, however any adverse
events should be reported.
* Early or late loosening of the prosthetic components(s), often related to
factors listed in WARNINGS and PRECAUTIONS.
* Change in position of the prosthesis, often related to factors listed in
WARNINGS and PRECAUTIONS.
* Subluxation or dislocation of the replaced joint.
* Temporary inferior subluxation (this condition generally disappears as muscle
tone is regained).
* Early or late infection.
* Hematoma and/or delayed wound healing.
* Cardiovascular disorders including venous thrombosis, pulmonary embolism and
myocardial infarction.
* Pneumonia and/or atelectasis.
* Systemic or local adverse events or complications resulting from anaesthesia.
There are no potential benefits to study subjects from participation in this
study. The knowledge gained from this investigation may help future shoulder
arthroplasty patients.
Cesar Domelahof 24
Utrecht 3544MJ
NL
Cesar Domelahof 24
Utrecht 3544MJ
NL
Listed location countries
Age
Inclusion criteria
Subjects meeting all of the following specific criteria will be considered for
participation in the study:
- 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 will be excluded from participation in the study if they meet any of
the following 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
- Either preoperatively or intraoperatively bone stock in the proximal humerus
or glenoid fossa is determined to be inadequate for supporting the GLOBAL ICON
stemless humeral components
- Intraoperatively, bone is determined to be 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03168672 |
| CCMO | NL62192.048.17 |