Main objective is to determine the survival rate of the AGC total knee arthroplasty system with a follow-up of 15 to 20 years. Secondary Objective(s): to determine the physical function of the patients by means of a physical examination and a…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the total number of failures in the cohort. Failure
is defined as revision of one or more parts of the implant.
Secondary outcome
Secondary study parameters are function of the knee, physical functioning and
quality of life of the patient and signs of loosening and wear. Other study
parameters are age, gender, length and weight (body mass index), diagnosis,
treated site, surgeon, comorbidity and complications.
Background summary
Total knee arthroplasty (TKA) is a well-established procedure, which generally
results in relief of pain, improved physical function, and a high level of
patient satisfaction. The Anatomic Graduated Component (AGC) TKA system is a
common used implant in the treatment of osteoarthrosis and rheumatoid
arthritis. To date, research is performed into the survival and functional
outcome in studies with up to 15 years of follow-up.
The Orthopaedic department of the Martini Hospital Groningen, the Netherlands,
began to use the AGC system in 1987. The cohort 1987-1992 will provide data on
the 15 to 20 years survival of the AGC total knee arthroplasty system. This is
an interesting cohort, because its follow-up term exceeds the 15 years
follow-up described earlier in literature. Moreover, to the best of our
knowledge, no survival and functional analysis of the AGC is performed in the
Dutch population.
Study objective
Main objective is to determine the survival rate of the AGC total knee
arthroplasty system with a follow-up of 15 to 20 years. Secondary Objective(s):
to determine the physical function of the patients by means of a physical
examination and a questionnaire and to determine whether there are signs of
loosening or wear of the prosthesis as shown on the X-ray. Additional objective
is to perform research on the determinants of survival rate of the AGC total
knee arthroplasty system.
Study design
The study is a retrospective cohort study. The cohort will consist of patients
who had an AGC total knee arthroplasty between 1987 and 1992. The study will be
executed at the Orthopedic department of the Martini Hospital in Groningen, the
Netherlands. Duration of the study will be 6 months.
Study burden and risks
The burden for the participants is minimal. Only one visit to the outpatient
clinic with a duration of 60 minutes is needed. The risks are negligible as a
routine control procedure is followed.
Postbus 30033
9700 RM Groningen
Nederland
Postbus 30033
9700 RM Groningen
Nederland
Listed location countries
Age
Inclusion criteria
AGC total knee arthroplasty system between 1987 and 1992
Exclusion criteria
AGC total knee arthroplasty system after 1992
Design
Recruitment
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 | NL18242.056.07 |