Short-term results of total ankle arthroplasty with use of a novel mobile-bearing design.
Recruiting
- Conditions
- ankle arthritisinflammatory joint disease10023213
- Registration Number
- NL-OMON33834
- Lead Sponsor
- Slotervaartziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion Criteria
All patients treated in the Slotervaartziekenhuis with a CCI ankle prosthesis, between november 2003 and january 2008.
Exclusion Criteria
No
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Patient satisfaction with use of clinical scores and questionnaires.<br /><br><br /><br>The following methods will be used:<br /><br>§ The Ankle-Hindfoot Score developed by the American Orthopaedic Foot and Ankle<br /><br>Society (AOFAS), a 100-point scoring system constituted of both subjective and<br /><br>objective clinical parameters.<br /><br>§ The Foot Function Index (FFI), a patient derived questionnaire of 23 items,<br /><br>which refers to residual complaints in foot and ankle during daily life (past<br /><br>week). A Dutch version of this questionnaire has been validated.<br /><br>§ A Visual Analog Scale (VAS) will be used to score residual pain, limitation<br /><br>of functioning and satisfaction of treatment result. See the appendices for<br /><br>examples.<br /><br><br /><br>Chart review to record any complication related to the total ankle<br /><br>arthroplasty.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Radiographs are studied before, directly after and at latest follow up. These<br /><br>measurements will be carried out by a radiologist not being involved in the<br /><br>treatment of these patients.<br /><br><br /><br>Criteria used for follow up were as follow:<br /><br>1. Pre-operative grading of arthritis of the ankle joint, and pre- and<br /><br>post-operative grading of the subtalar joint.<br /><br>2. Position of the hindfoot (varus/valgus) pre-operative and position of the<br /><br>prosthesis (varus/valgus) post-operative.<br /><br>3. Osseous integration of the prosthesis. Radiolucency more then 2mm,<br /><br>cavitation or migration of the components were markers of loosening.<br /><br>4. Measurement of the tibiotalar ratio.<br /><br>5. Measurement of the inclination of the tibial component to the long axis of<br /><br>the tibia.</p><br>