The primary objective of this study is to assess the improvement in clinical outcome of rTSA with Glenius one year after surgery. The secondary objectives are to gather patient-reported clinical outcomes, radiological outcomes (implant position/…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Clinical outcome will measured with Constant-Murley Score before surgery and
at each follow-up visit. One and 5-year follow-up score will be compared to the
pre-surgery score.
Secondary outcome
• Patient reported clinical outcome measures (PROMS) will be collected through
Simple Shoulder Test (SST), Oxford ShoulderScore, general health EQ5D and pain
and satisfaction scores via Visual Analogue Scales (VAS) before surgery and at
each visit.
• The accuracy of implant position will be measured by calculating positional
and rotational deviations of the implant position onpost-operative CT scan when
compared to the planned position on the pre-operative CT scan.
• Implant stability will be assessed by calculating translational and
rotational deviations on a CT scan 1 year after surgery, comparedto the
position on the post-operative CT scan.
• Other radiological outcomes will be identified and graded on the X-rays:
scapular notching, radiolucencies and heterotopicossification after surgery at
each follow-up visit.
• Implant survival will be calculated by collecting dates of implant revision
surgeries.
• Collecting (severe) adverse (device) events: device/shoulder related A(D)Es,
SA(D)Es and device deficiencies that could have led to an SAE will be
collected.
Background summary
The Glenius Glenoid Reconstruction system provides a patient-specific solution
for the treatment of glenoid defects in reversed total shoulder arthroplasty
(rTSA). Better understanding of clinical outcome may improve the success of
surgery and implants leading to reduced (re-)revision rates. Counselling of
patients and surgical planning may be improved. Furthermore, clinical outcome
data on specific surgical techniques and implants is useful from a general
health economics perspective, and more specific to support reimbursement and
insurance requests . Therefore, the current study protocol on primary and
revision shoulder arthroplasty outcome with Glenius was set up to gather
clinical follow-up data in a standardized way.
Study objective
The primary objective of this study is to assess the improvement in clinical
outcome of rTSA with Glenius one year after surgery. The secondary objectives
are to gather patient-reported clinical outcomes, radiological outcomes
(implant position/migration, complications), implant revision rates and safety
up to 5 years after surgery.
Study design
The study is designed as a prospective interventional case series study with a
follow-up of 5 years. No case control group is included.
Study burden and risks
Patients participating in this study will not be subjected to any additional
risk other than the regular risks for rTSA, compared to patients receiving
treatment outside the study. Only the additional post-op CT scan(s) 1 year
after surgery will pose an additional radiation risk of 2.1 mSv, which is lower
than one year of natural background radiation (2.5 mSv). The patients will
visit the clinic at regular follow-up moments including standard physical
examinations and radiographic assessments. The patients will be asked to fill
out the questionnaires prior to the clinical examination visit, which will take
a few minutes (15min) of their time.
Technologielaan 15
Leuven 3001
BE
Technologielaan 15
Leuven 3001
BE
Listed location countries
Age
Inclusion criteria
• patients having primary or revision shoulder joint replacement with severe
glenoid bone defects caused by: (1) Non-inflammatory degenerative joint disease
including osteoarthritis and avascular necrosis, (2) Inflammatory degenerative
joint disease such as rheumatoid arthritis; (3) Congenital malformations,
posttraumatic deformities or removal of components during revision surgery
• Patient is 18 years of age or older
• Patient can follow the Glenius system procedure that is standard of care and
according to the appropriate Glenius system instructions for use.
• Patient has participated in the informed consent process and has signed the
EC approved informed consent form
Exclusion criteria
• Pregnant patients
• Skeletally immature patients
• Prisoners
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 | NCT03806881 |
| CCMO | NL64181.091.19 |