The objective of the present study is to investigate the long-term effect (15 years follow-up) of triple arthrodesis on the ankle joint and the development of secondary OA of the ankle joint. Additionally, alignment and clinical outcomes will be…
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 level of OA graded with the Kellgren and Lawrence
score on an X-rays of the ankle and foot.
Secondary outcome
The Meary*s angle will be measured to evaluate the bony alignment of the foot.
Standardized digital photos will be made to assess the geometry/alignment.
Additionally, with two questionnaires, the Foot Function Index (FFI) and the
American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score, the
clinical outcome will be investigated.
Background summary
Triple arthrodesis is an operative salvage procedure for treatment of painful,
deformed and/or unstable tarsal joints. However, debate exists regarding the
effect of triple fusion on the development of osteoarthritis (OA) of the ankle
joint. Since, triple arthrodesis is a technical difficult procedure and
correction of the shape/alignment of the foot may be not as adequate as
intended, malalignment might persist after operative correction. Malalignment
may be more important in determining OA of the ankle than the fusion itself.
The hypothesis is that after a mean follow up time of 15 years, the geometry
and subjective outcome would remain improved. Compared with the earlier
evaluation (at 2 and 7.5 years), an increase of OA of the ankle joint is
expected. More specific, the increase of OA is expected to be mild and
associated with pre-existing OA of the ankle joint and/or associated with
persistent malalignment of the foot after triple fusion.
Study objective
The objective of the present study is to investigate the long-term effect (15
years follow-up) of triple arthrodesis on the ankle joint and the development
of secondary OA of the ankle joint. Additionally, alignment and clinical
outcomes will be examined.
Study design
This follow-up study is a prospective cohort study
Study burden and risks
Patients are asked to visit our clinic once. The extra amount of time that a
patient invests in the study is about 1 hour. Prior to the visit the patients
are asked to fill in a questionnaire (FFI), during the visit X-rays and digital
photos of the ankle/foot will be taken and the physician will perform a
physical examination (AOFAS). The questionnaires and physical examination of
the foot do not bring any extra burden. The additional radiological assessment
has a radiation amount of 0.001 mSv and is minimal compared with the natural
radiation of 2 mSv per year.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
Patients who underwent a triple arthrodesis in the period 1999 to 2002 in the Sint Maartenskliniek
Exclusion criteria
Not signing informed consent
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 | NL53881.048.15 |