Clinical Trials Directory

Trials / Completed

CompletedNCT04823884

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

Short-term Results After Minimally Invasive Chevron Osteotomy for Hallux Valgus Correction in Comparison to the Open Technique

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Dr.Gerhard Kaufmann · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREopen distal chevron osteotomyThrough 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.
PROCEDUREminimally invasive distal chevron osteotomyThe 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.

Timeline

Start date
2021-04-01
Primary completion
2023-06-30
Completion
2023-06-30
First posted
2021-04-01
Last updated
2023-11-07

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT04823884. Inclusion in this directory is not an endorsement.