A post marketing surveillance study to assess safety, clinical performance and survival of the uncemented Glenoid Affinis vitamys Uncemented Glenoid Affinis Vitamys total prosthetic shoulder replacement. All implants already bear the CE-marking.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is the survival RLL score according to Molé
at five years of the Uncemented uncemented Glenoid Affinis Vitamysvitamys.
Secondary outcome
The secondary endpoints of the study are the clinical outcomes and performance
of the Uncemented Glenoid Affinis Vitamys, complication rate after surgery, and
patients reported outcome measures (PROMS) pre-operative as well as
post-surgery. The final endpoint is the product survival rate of the
Uncemented Glenoid Affinis Vitamys at ten years.
Background summary
Glenoid component loosening is still one of the major problems in shoulder
arthroplasty. Multiple factors including the method of glenoid preparation,
cementing technique, implant-material etc. are considered potential reasons for
loosening within the cement-bone interface. Cementless fixation for
arthroplasty is not a new concept and has been used in the hip and the knee for
many years. However, experience with cementless fixation for shoulder
arthroplasty remains small especially for a primary monoblock glenoid
component. The vitamys (vitamin E blended highly cross-linked polyethylene)
material used for the Affinis Glenoid vitamys uncemented components has been in
clinical use since 2009. The first application was a monoblock cup implant (RM
pressfit vitamys) which is used for total hip arthroplasty.
Study objective
A post marketing surveillance study to assess safety, clinical performance and
survival of the uncemented Glenoid Affinis vitamys Uncemented Glenoid Affinis
Vitamys total prosthetic shoulder replacement. All implants already bear the
CE-marking.
Study design
Open-label Single-arm prospective observational multicentre study
Study burden and risks
Patients can choose whether to participate in the study and receive the
uncemented Glenoid Affinis vitamysaffinis glenoid vitamys uncemented.
Alternative option is the total shoulder arthroplasty performed as standard of
care in the sites. In addition to the benefits from the TSA surgery e.g.
reduced pain, improved range of motion, patients might benefit from the type
ofuncemented shoulder prosthesis that will be used in this study in terms of
the shorter surgery time and reduced damage in case of revision associated with
uncemented arthroplasty in general. There is minimal risk associated with
participating in this study over and above that of the primary shoulder
arthroplasty procedure. All devices are CE marked and will be used according to
its labelling. Data collection involves usual care after the surgery, namely
questionnaires (PROMs), radiographs and range of motion, with an additional
radiographic evaluation at 2 years follow-up.
Molengracht 21
Breda 4818CK
NL
Molengracht 21
Breda 4818CK
NL
Listed location countries
Age
Inclusion criteria
Primary TSA implantation
Primary osteoarthritis, secondary osteoarthritis, fracture sequelae, avascular
necrosis of the humeral head
Age at inclusion >18 years
Intact rotator cuff
Glenoid retroversion <15% and <70% humeral head subluxation (Walch type A1, A2,
B1, B2 glenoid)
Exclusion criteria
Missing consent
Rheumatoid athritis
Known or suspected non-compliance (e.g. drug or alcohol abuse)
Revision surgery
Presence of sepsis or malignant tumours
Chemotherapy treatment within 6 months before surgery
>5mg/day of corticosteroids, excluding inhalers, within 3 months before surgery
Women who are pregnant or breast feeding
Glenoid retroversion >15% (Walch type C glenoid)
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 |
|---|---|
| CCMO | NL79929.100.22 |