The objective of this retrospective consecutive series PMCF study is to collect long-term data confirming safety, performance and clinical benefits of the Vanguard PS Open Box Porous Femoral (implants and instrumentation) when used for total knee…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
bewegingsapparaat
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of safety by recording and analyzing the incidence and frequency of
revisions, complications and adverse events. Relation of the events to implant,
instrumentation and/or procedure should be specified.
Secondary outcome
Performance and clinical benefits demonstrated by PROMs (patient-reported
out-come measures).
Radiographic Outcomes from conventional X-rays and evaluation of induced micro
motion using CT-scans and valgus-varus loading of the knee joint.
Background summary
Post-market Clinical Follow-up Study to Provide Safety, Performance and
Clinical Benefits Data of the Vanguard PS Open Box Porous Femoral (Implants and
Instrumentation)
Study objective
The objective of this retrospective consecutive series PMCF study is to collect
long-term data confirming safety, performance and clinical benefits of the
Vanguard PS Open Box Porous Femoral (implants and instrumentation) when used
for total knee arthroplasty.
The primary objective is the assessment of safety by analyzing implant
survivorship. This will be established by recording the incidence and frequency
of revisions, complications and adverse events. Relation of the events to
implant, instrumentation and/or procedure should be specified.
The secondary objective is the assessment of performance and clinical benefits
by recording patient-reported clinical outcome measures (PROMs) as well as
radiographic outcomes (conventional bi planar x-rays and CT-scan).
Study design
Monocentric, Consecutive series
Study burden and risks
Subjects who meet the indications and none of the contraindications will be
contacted by the investigator and offered participation in the study. The
investigator should introduce the clinical study to the subject by explaining
the clinical study plan, procedures and objectives. A Patient Information and
Consent Form as well as a General Data Protection Regulation notice (GDPR
notice) and the questionnaires will be provided to all patients when coming
back for the follow-up visit. During this visit the patients will be able to
ask any questions regarding the study participation. Once all questions could
be answered, the patient will decide on their study participation.
When the subject has decided to participate a visit will be scheduled in which
the following data will be collected: Pain and functional performance as
reported by PROMs (OKS, KOOS), Clinical examination: pain scores, range of
motion, walking distance), Radiographic outcome: evaluation of conventional
x-rays and evaluation of induced micro motion using CT-scans under valgus-varus
load, Complications/Adverse Event and date of its occurrence (relation to
implant, instrumentation and/or procedure should be specified), Implant
removal/revision, date of revision and reason (relation to implant,
in-strumentation and/or procedure should be specified)
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
This study is focused on patients treated with the Vanguard PS Open Box Porous
Femoral between 2009 and 2013 within the Amsterdam UMC, location AMC.
The Vanguard PS Open Box Porous Femoral prosthesis is indicated for patients
treated for:
• Painful and disabled knee joint resulting from osteoarthritis, rheumatoid
arthritis, traumatic arthritis where one or more compartments are involved.
• Correction of varus, valgus, or posttraumatic deformity.
• Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of
previous joint replacement procedure.
Additionally, in order to be eligible to participate in this study, a subject
must meet the following criteria:
• The participant must be able to understand the Dutch language in order to
complete the questionnaires.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Off label use.
Absolute contraindications include:
• Infection.
• Sepsis.
• Osteomyelitis.
Relative contraindications include:
• An uncooperative patient or a patient with neurologic disorders who is
incapable of following directions.
• Osteoporosis.
• Metabolic disorders which may impair bone formation.
• Osteomalacia.
• Distant foci of infections which may spread to the implant site.
• Rapid joint destruction, marked bone loss or bone resorption apparent on
roentgenogram.
• Vascular insufficiency, muscular atrophy, neuromuscular disease, and/or
incomplete or deficient soft tissue surrounding the knee.
Subgroup exclusion criteria:
• For the subgroup analysis to determine variability in methodological error,
bilateral patients are excluded from the subgroup since they will already be
exposed to an additional scan.
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 | NL85030.018.23 |