search
Back to results

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

Primary Purpose

Hallux Valgus, Minimally Invasive Surgical Procedures

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
open distal chevron osteotomy
minimally invasive distal chevron osteotomy
Sponsored by
Dr.Gerhard Kaufmann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Priv-Doz. Dr. Gerhard KaufmannRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

open distal chevron osteotomy

minimally invasive distal chevron osteotomy

Arm Description

Hallux valgus correction is provided by using the traditional open distal v-shaped chevron osteotomy.

Hallux valgus correction is provided by using a minimally invasive distal v-shaped chevron osteotomy.

Outcomes

Primary Outcome Measures

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 .
Clinical outcome is assessed for both techniques with a clinical score to specific time points. AOFAS Hallux Metatarsophalangeale -Interphalangeale Scale [maximum 100 points, minimum 0 points - higher scores mean better outcome]
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 .
Clinical outcome is assessed for both techniques with a clinical score to specific time points. Maryland Foot Score [maximum 100 points, minimum 0 points - higher scores mean better outcome]
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 .
Clinical outcome is assessed for both techniques with clinical a score to specific time points. JSSF Hallux Metatarsophalangeale -Interphalangeale Scale [maximum 100 points, minimum 0 points - higher scores means better outcome]
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 .
Clinical general situation is assessed for both techniques to specific time points by using the SF12 Life Quality Score [maximum 47 points, minimum 0 points - higher scores mean better clinical situation]
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 .
Clinical outcome and therefore the pain level is assessed for both techniques to specific time points by using the Visual Analogue Score for pain [0-10])
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 .
Clinical outcome is assessed for both techniques to specific time points by assessing the Range of motion (normal range 70-0-45 degrees)
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 .
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).

Secondary Outcome Measures

Full Information

First Posted
March 14, 2021
Last Updated
April 22, 2022
Sponsor
Dr.Gerhard Kaufmann
search

1. Study Identification

Unique Protocol Identification Number
NCT04823884
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr.Gerhard Kaufmann

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus, Minimally Invasive Surgical Procedures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
after completion of data collection personal data is anonymized. Outcomes assessor adds up the scores without knowing the type of surgery. The principal investigator as well as the statistical investigator do receive the completed anonymized excel file for doing the statistical analysis
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
open distal chevron osteotomy
Arm Type
Active Comparator
Arm Description
Hallux valgus correction is provided by using the traditional open distal v-shaped chevron osteotomy.
Arm Title
minimally invasive distal chevron osteotomy
Arm Type
Active Comparator
Arm Description
Hallux valgus correction is provided by using a minimally invasive distal v-shaped chevron osteotomy.
Intervention Type
Procedure
Intervention Name(s)
open distal chevron osteotomy
Other Intervention Name(s)
austin osteotomy
Intervention Description
Through a 4-cm-long dorsomedial skin incision the V-shaped osteotomy with the apex 1-2 mm superior to the center of the metatarsal head is performed. The angle of the chevron is 60° to 90°. The direction of the osteotomy is angled toward the center of the third metatarsal head. After shifting the metatarsal head laterally, fixation is achieved by usage of one cannulated screw (3.0 mm or 2.5mm). Prominent bone ridges are resected with a saw. A distal soft tissue procedure is performed in every case through the same skin incision. The adductor hallucis tendon is detached from its insertion at the phalangeal bone and from the lateral border of the fibular sesamoid. The transverse intermetatarsal ligament is released and a T-shaped capsulotomy is performed to allow reposition of the sesamoids. Sesamoid position is controlled by sight. After closing of the medial capsula skin is closed with nylon sutures.
Intervention Type
Procedure
Intervention Name(s)
minimally invasive distal chevron osteotomy
Intervention Description
The osteotomy is performed percutaneously through a dorsomedial incision of 3-5 mm. An electric motor-driven machine used for the osteotomy. To prevent overheating the reamer is frequently rinsed with sterile saline. The medial eminence is excised and the V-shaped osteotomy is performed. The apex of the osteotomy is identified by fluoroscopy and centered 1-2 mm superior to the center of the metatarsal head. The angle of the osteotomy amounts to 60-90 degrees as well. Bone debris is washed out with sterile saline. A lateral soft-tissue release is undertaken through a separate lateral incision of 3-5 mm. The distal fragment is shifted laterally and fixed with a canulated screw of 3.5mm. Residual bone ridges are reamed. Position of the metatarsal head and the K-wire is controlled by fluoroscopy. The skin is closed with a nylon sutures.
Primary Outcome Measure Information:
Title
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 .
Description
Clinical outcome is assessed for both techniques with a clinical score to specific time points. AOFAS Hallux Metatarsophalangeale -Interphalangeale Scale [maximum 100 points, minimum 0 points - higher scores mean better outcome]
Time Frame
Change of the scores from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Title
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 .
Description
Clinical outcome is assessed for both techniques with a clinical score to specific time points. Maryland Foot Score [maximum 100 points, minimum 0 points - higher scores mean better outcome]
Time Frame
Change of the scores from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Title
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 .
Description
Clinical outcome is assessed for both techniques with clinical a score to specific time points. JSSF Hallux Metatarsophalangeale -Interphalangeale Scale [maximum 100 points, minimum 0 points - higher scores means better outcome]
Time Frame
Change of the score from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Title
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 .
Description
Clinical general situation is assessed for both techniques to specific time points by using the SF12 Life Quality Score [maximum 47 points, minimum 0 points - higher scores mean better clinical situation]
Time Frame
Change of the SF 12 score from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Title
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 .
Description
Clinical outcome and therefore the pain level is assessed for both techniques to specific time points by using the Visual Analogue Score for pain [0-10])
Time Frame
Change of the VAS from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Title
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 .
Description
Clinical outcome is assessed for both techniques to specific time points by assessing the Range of motion (normal range 70-0-45 degrees)
Time Frame
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
Title
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 .
Description
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).
Time Frame
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
Other Pre-specified Outcome Measures:
Title
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 .
Description
Clinical fitness of our cohort is assessed by means of the Charlson Comorbidity Index [maximum 37 points, minimum 0 points - lower scores mean clinical situation] preoperatively.
Time Frame
This score is used to compare the clinical fitness of both cohorts preoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Priv-Doz. Dr. Gerhard Kaufmann
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Kaufmann, MD
Phone
+43436642186497
Email
gerhard.kaufmann9@chello.at
First Name & Middle Initial & Last Name & Degree
Michael Liebensteiner, MD
First Name & Middle Initial & Last Name & Degree
Franz Endstrasser, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs