Clinical trial NCT04823884: Short-term Results After Minimally Invasive Chevron Osteotomy for Hallux Valgus Correction
Official title: Short-term Results After Minimally Invasive Chevron Osteotomy for Hallux Valgus Correction in Comparison to the Open Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Minimally Invasive Surgical Procedures
Lead sponsor: OFZ Innsbruck
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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 .
timeFrame: Change of the scores from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
measure: 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 .
timeFrame: Change of the scores from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
measure: 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 .
timeFrame: Change of the score from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
measure: 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 .
timeFrame: Change of the SF 12 score from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
measure: 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 .
timeFrame: Change of the VAS from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
measure: 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 .
timeFrame: Change of the range of motion and therefore the clinical outcome from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
measure: 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 .
timeFrame: 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
Secondary outcomes:
Other outcomes:
measure: 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 .
timeFrame: This score is used to compare the clinical fitness of both cohorts preoperatively.
Locations:
city: Innsbruck
country: Austria
facility: Priv-Doz. Dr. Gerhard Kaufmann
state: Tyrol
Study officials:
References: