An interventional study of open distal chevron osteotomy and minimally invasive distal chevron osteotomy in Hallux Valgus and Minimally Invasive Surgical Procedures, sponsored by Dr.Gerhard Kaufmann. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Dr.Gerhard Kaufmann · Not applicable, Interventional, and Treatment
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.
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.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's enrollment of 60 is close to the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Dr.Gerhard Kaufmann is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Hallux valgus correction is provided by using the traditional open distal v-shaped chevron osteotomy.
Procedure: open distal chevron osteotomy
Hallux valgus correction is provided by using a minimally invasive distal v-shaped chevron osteotomy.
Procedure: minimally invasive distal chevron osteotomy
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.
Also known as: austin osteotomy
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.
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 etmatarsophalangeal -interphalangeal 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
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 \[maximum 100 points, minimum 0 points - higher scores mean better outcome\]
Time frame: Change of the scores from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
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 metatarsophalangeal -interphalangeal 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
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 \[maximum 47 points, minimum 0 points - higher scores mean better clinical situation\]
Time frame: Change of the SF 12 score from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
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 \[0-10\])
Time frame: Change of the VAS from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
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)
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
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).
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
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 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.
Ran from Apr 2021 to primary completion in Jun 2023, 26 months.
Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's 26 months is close to that.
Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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