deformity of the toes Rigid claw toes
Conditions
Interventions
For patients in Part I the study group will be treated according to the
minimally invasive technique as described by De Prado et al., the control group
will be treated with traditional open surgery.
Sponsors
Isala Klinieken
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >=18 and
Exclusion criteria
Exclusion criteria: - Standard contraindications for claw toe surgery (e.g. active infection, inadequate vascular supply) - Inability to understand or correctly interpret the questionnaires (mental retardation, language barrier) - Previous foot surgery on the ipsilateral foot - Concomitant surgery on the ipsilateral foot (e.g. hallux valgus surgery, bunionette) - Unlikely to comply with the long follow-up (e.g. severe comorbidity, impaired life expectancy) - Comorbidity that affects foot function (e.g. severe neuropathy, paralysis, severe osteoarthritis of the foot or ankle (Kellgren-Lawrence score >3), symptomatic hallux valgus)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the Foot Function Index (FFI) after 2 years. The FFI is a patient reported outcome measure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include the AOFAS (Lesser Metatarsophalangeal-Interphalangeal Scale), NRS pain score, NRS satisfaction score and return to work/activities. Furthermore, failure and complication rates are assessed, as are perioperative variables. Furthermore, a prediction model for FFI outcome will be created to assess which patiënts are most suitable for the MIS technique. Furthermore. a learning curve assessment will be done based on two year FFI scores, AOFAS score, NRS pain score and NRS satisfaction score. Aditionally, assessment of the effect size (treatment effect) will be done by comparing preoperative scores to postoperative scores at the various time points. | — |
Countries
Netherlands
Outcome results
None listed