The objective of this study is to investigate if the CCI prosthesis gives comparable or better short-term results then other prostheses like the Buechel-Pappas and Star prosthesis with regard to patient satisfaction, physical examination and…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient satisfaction with use of clinical scores and questionnaires.
The following methods will be used:
§ The Ankle-Hindfoot Score developed by the American Orthopaedic Foot and Ankle
Society (AOFAS), a 100-point scoring system constituted of both subjective and
objective clinical parameters.
§ The Foot Function Index (FFI), a patient derived questionnaire of 23 items,
which refers to residual complaints in foot and ankle during daily life (past
week). A Dutch version of this questionnaire has been validated.
§ A Visual Analog Scale (VAS) will be used to score residual pain, limitation
of functioning and satisfaction of treatment result. See the appendices for
examples.
Chart review to record any complication related to the total ankle
arthroplasty.
Secondary outcome
Radiographs are studied before, directly after and at latest follow up. These
measurements will be carried out by a radiologist not being involved in the
treatment of these patients.
Criteria used for follow up were as follow:
1. Pre-operative grading of arthritis of the ankle joint, and pre- and
post-operative grading of the subtalar joint.
2. Position of the hindfoot (varus/valgus) pre-operative and position of the
prosthesis (varus/valgus) post-operative.
3. Osseous integration of the prosthesis. Radiolucency more then 2mm,
cavitation or migration of the components were markers of loosening.
4. Measurement of the tibiotalar ratio.
5. Measurement of the inclination of the tibial component to the long axis of
the tibia.
Background summary
Total ankle arthroplasty (TAA) is an alternative for arthrodesis in the painful
arthritic ankle. TAA has the advantage of preserving a normal gait pattern with
less compensatory motion in other joints. Ankle arthrodesis, however, is
associated with deterioration of the joints of the foot, which eventually
causes arthritis, pain and dysfunction.
Promising results are seen with 3-component mobile-bearing systems.
Advantages of the mobile-bearing prosthesis is its low intrinsic constraints,
and thereby its low wear characteristics, and the possibility to obtain
adequate stability by implanting a bearing of adequate thickness. Several
different designs of 3- component mobile bearing arthroplasties are in clinical
use, but the literature on most of these new designs is sparse or absent.
Two mobile bearing designs are known for their encouraging intermediate to
long- term follow up: the Buechel-Pappas prosthesis and the STAR prosthesis. A
study by Buechel et al showed a 20-year survival rate of the shallow-sulcus
design (LCS prosthesis) of 74%. After modification to a deeper sulcus-design
(the Buechel-Pappas prosthesis) a 92% survival rate was reported at 12 years
follow-up in a patient population mostly suffering from posttraumatic arthritis
or primary arthritis. Disadvantage of this specific design is that a window has
to be created for the stem of the tibial component, and that the preparation of
the talus is not very well controlled by the instruments.
Fevang et al. found a five to ten year survival for the STAR arthroplasty of
89% and 76% respectively. A five years survival of 70% was found by Anderson.
Disadvantages of the STAR prosthesis are the central groove in the bearing,
making it vulnerable for wear and/or fracture of the polyethylene bearing.
Furthermore, the fixation of the tibial component is not always reliable in
softer bone.
The CCI prosthesis (Van Straten, Nieuwegein, the Netherlands) was developed to
overcome several of the weaknesses of other designs. It requires minimal bone
resection both on the tibial and the talar side, has a good primary stability,
and due to the ceramic coating of the metallic components superior wear
characteristics. This prosthesis was introduced in the Slotervaartziekenhuis in
2003 in order to overcome some difficulties encountered with the use of the
Buechel-Pappas prosthesis.
Study objective
The objective of this study is to investigate if the CCI prosthesis gives
comparable or better short-term results then other prostheses like the
Buechel-Pappas and Star prosthesis with regard to patient satisfaction,
physical examination and radiology at follow-up.
Study design
Observational, cohort study.
Study burden and risks
Patients need to come for one extra follow-up visit (if not recently been seen
for follow-up), 2 weightbearing X-rays of the ankle need to be made (if not
recently been made), and they have to fill in a questionnaire and 3 VAS scales.
louwesweg 6
1066ec, Amsterdam
Nederland
louwesweg 6
1066ec, Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
All patients treated in the Slotervaartziekenhuis with a CCI ankle prosthesis, between november 2003 and january 2008.
Exclusion criteria
No
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 | NL26294.048.09 |