First metatarsophalangeal joint arthrodesis vs implant arthroplasty; Prospective randomised clinical trial.
Recruiting
- Conditions
- hallux limitushallux rigidus10023213osteoartritis of the first metatarsophalangeal joint
- Registration Number
- NL-OMON39417
- Lead Sponsor
- Spaarne Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
MTPI degenerative arthritis stage II or III
Exclusion Criteria
Diabetes
neurogenic disorders
age above 70 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* AOFAS-HMI score<br /><br>* VAS pain score<br /><br>* Satisfaction score </p><br>
- Secondary Outcome Measures
Name Time Method <p>* X-ray evaluatie ( anterior-posterior en lateraal)<br /><br>o DMAA angle<br /><br>o IMA angle<br /><br>o lengte eerste metatarsaal<br /><br>o Fusie in de arthrodesis groep<br /><br>o Positie van hardware in de prothese groep<br /><br>* SF-12 (dutch validated) quality of life score<br /><br>* Gait analysis (Dynaport® device)<br /><br>* voetdrukmeting (footscan® USB plate by RS International®)<br /><br>* Lichamelijk onderzoek<br /><br>o Range of motion van IP een MTPI<br /><br>o Stbiliteit van gewricht</p><br>