PROspective Minimally Invasive Surgery of the toes A prospective cohort study

Completed

Conditions: deformity of the toes
Rigid claw toes
10023213
10005944

Registration Number: NL-OMON55493

Lead Sponsor: Isala Klinieken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- Age >=18 and <=75
- Symptomatic rigid claw toes, according to the definition by Schrier et al.
(2009)
- Indication for surgical treatment

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)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the Foot Function Index (FFI) after 2 years. The<br /><br>FFI is a patient reported outcome measure.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures include the AOFAS (Lesser<br /><br>Metatarsophalangeal-Interphalangeal Scale), NRS pain score, NRS satisfaction<br /><br>score and return to work/activities. Furthermore, failure and complication<br /><br>rates are assessed, as are perioperative variables. Furthermore, a prediction<br /><br>model for FFI outcome will be created to assess which patiënts are most<br /><br>suitable for the MIS technique.<br /><br><br /><br>Furthermore. a learning curve assessment will be done based on two year FFI<br /><br>scores, AOFAS score, NRS pain score and NRS satisfaction score. Aditionally,<br /><br>assessment of the effect size (treatment effect) will be done by comparing<br /><br>preoperative scores to postoperative scores at the various time points.</p><br>