Short-term Results After Minimally Invasive Chevron Osteotomy for Hallux Valgus Correction

Not Applicable

Completed

• Conditions: Hallux Valgus; Minimally Invasive Surgical Procedures

• Registration Number: NCT04823884
• Lead Sponsor: Dr.Gerhard Kaufmann

Brief Summary

By means of clinical satisfaction and clinical scores comparison of an open to a minimally invasive distal chevron osteotomy for correction of a hallux valgus deformity is performed.

Detailed Description

The aim of this study is to evaluate shortterm clinical outcome after a minimally invasive chevron osteotomy technique for correction of hallux valgus deformity in comparison to the open distal chevron technique. Patients undergoing a distal chevron osteotomy for correction of a hallux valgus deformity are assigned to one of the two groups. Survey is taken preoperatively, after 2, 4, 6 and 12 weeks postoperatively. Assessment of the clinical outcome measures in terms of the range of motion (ROM), Visual Analogue Scores (VAS) of pain, the American Orthopaedic Foot and Ankle Society (AOFAS) forefoot Score and a patient satisfaction score and a Life Quality score (SF 12) as well as the evaluation of the Charlson Comorbidity score is performed. It is hypothesized, that clinical outcome with the minimally invasive distal chevron osteotomy is superior to the open technique.

Study Timeline

• Study First Submitted: 2021-03-14
• Study First Submitted QC: 2021-03-29
• Study Start: 2021-04-01
• Study First Posted: 2021-04-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• all patients undergoing hallux valgus correction by means of a distal chevron osteotomy

Exclusion Criteria

• surgery on the lesser rays of the same foot
• mental illness with impossibility to follow the postoperative protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .	Change of the foot circumference at the level of surgery from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured	Clinical outcome and therefore changes of the foot circumference at the level of surgery is assessed for both techniques to specific time points by measuring the foot circumference at the level of surgery (measurement in centimeter).

Trial Locations

Locations (1)

Priv-Doz. Dr. Gerhard Kaufmann; 🇦🇹 Innsbruck, Tyrol, Austria