The purpose of this study is to determine the survival rates of the IBP total elbow prosthesis, to give insight into the migration pattern of the IBP prosthesis and to evaluate the predictive value of early migration for future revision, loosening…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is the survival rate of the IBP elbow prosthesis.
Micromotion of the implant will be evaluated using RSA. The migration values
obtained at two years follow-up will be used to investigate the relation
between early migration (first two years postoperatively) and revision,
loosening and pain
Secondary outcome
Secondary endpoints include range of motion, Elbow Function Assessment, Elbow
Functional Rating Index, Oxford Elbow Score and VAS satisfaction.
Background summary
Radiostereometric Analysis (RSA) enables measurement of micromotion of
orthopaedic implants. A relation between early micromotion and future aseptic
loosening has been demonstrated for total hip and knee prostheses. Regarding
the elbow joint four RSA studies have been performed presenting short-term
results. Unfortunaletly long-term results are lacking and a predictive value of
early migration is not yet known. Between 2003 and 2006 16 IBP elbow prostheses
analysed using RSA, were described with a follow up time of two years. In the
present study we will investigate the long-term results (> 10 year follow-up)
of this cohort. The results are of great importance for the evaluation of elbow
prosthesis in the long-term and further evaluation of the role of RSA and the
investigation of the predictive value of early migration in the elbow joint.
Study objective
The purpose of this study is to determine the survival rates of the IBP total
elbow prosthesis, to give insight into the migration pattern of the IBP
prosthesis and to evaluate the predictive value of early migration for future
revision, loosening and pain. The secondary objective is to present the
clinical and functional outcomes 10 years after implantation of the IBP total
elbow prosthesis.
Study design
This follow-up study is a prospective study of a historic cohort.
Study burden and risks
Patients are asked to visit our clinic once, prior to a regular follow up
appointment. The extra amount of time that a patient invests in the study is
about 1 hour. Prior to the visit patients are asked to fill in the
questionnaires. During the visit RSA radiographs will be taken and a physical
examination will be performed. The questionnaires and physical examination will
not bring any additional burden for the patient. The total amount of radiation
of the RSA radiographs fall within the limits of the International Commission
of Radiological Protection (ICRP).
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
- Received an IBP total elbow prosthesis between June 2003 and February 2006.
- Participated in the study assessing the short-term results of the IBP total elbow prosthesis
- Sign informed consent for the proposed study.
Exclusion criteria
-
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 | NL59132.048.16 |