Comparing open and minimally invasive osteotomy for the surgical correction of bunions - a feasibility study

Not Applicable

Recruiting

• Conditions: Hallux Valgus; Musculoskeletal Diseases

• Registration Number: ISRCTN17635882
• Lead Sponsor: orthumbria Healthcare NHS Foundation Trust,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-02
• Last Update Posted: 8 April 2019
• Study Completion: 2020-09-13

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients over 18 years of age
2. Patients with Hallux valgus deformity suitable for treatment by both Open Scarf/Akin and MICA procedures
3. Patients with no significant co-morbidities that would increase their risk of procedure
4. Patients able to understand and complete questionnaires
5. Patients with the capacity to provide informed consent
6. Patients who have in addition to Hallux Valgus deformity, have lesser toe deformities requiring correction distal to the metatarsal phalangeal joint at time of procedure
7. Patients without significant other mid foot or hind foot pathology

Exclusion Criteria

1. Patients under 18 years of age
2. Patients with severity of Hallux valgus deformity necessitating Open procedure
3. Patients with significant co-morbidities that would increase the risk of surgery
4. Patients unable to understand or complete questionnaires
5. Patients without the capacity to provide informed consent
6. Patients with additional deformity requiring additional procedures proximal to the metatarsal phalangeal joint

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is feasibility of the study. This will be assessed via the number of patients able to be recruited into the study. Retention of those patients throughout the study and from analyzing the initial data, discussed in secondary outcome measures, to assess if any concerns are raised during the study period.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Patient reported outcomes - This outcome measure will be the patient reported outcomes obtained by patient questionnaire. MOXFQ-index will be obtained from patients’ questionnaires pre operatively for baseline and subsequently at 6 and 12 months for both groups<br> 2. Range of movement of the 1st MTPJ will be measured with a goniometer preoperatively and at Outpatient follow up and 6 weeks and 6 months. The differences between the two groups will be statistically analyzed<br> 3. Adverse Events are recorded through clinical observations throughout the post-operative period<br>