NCT02886221

Functional and Radiographic Outcomes of Hallux Valgus Correction by Mini-invasive Surgery With Reverdin-Isham Percutaneous Osteotomy

Functional and Radiographic Outcomes of Hallux Valgus Correction by Mini-invasive Surgery With Reverdin-Isham Percutaneous Osteotomy: a Longitudinal Prospective Study With a 48-month Follow-up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Minimally invasive surgery (MIS) represents one of the most innovative surgical treatments of Hallux Valgus (HV). However, long-term outcomes still remain a matter of discussion within the orthopaedic community. The purpose of this longitudinal prospective study was to evaluate radiographic and functional outcomes in patients with mild-to-severe HV who underwent Reverdin-Isham and Akin percutaneous osteotomy, following exostosectomy and lateral release.

Detailed description

One hundred and eighty patients with mild-to-severe symptomatic HV were treated by MIS. Clinical evaluation was assessed pre-operatively, as well as at 3 and 12 months after surgery and at final follow-up of 48 months, using the American Orthopaedic Foot and Ankle Society (AOFAS) Hallux grading system. Patient satisfaction and complications were recorded.Further parameters assessed were postoperative pain at rest and during movement by the numerical rating scale (NRS), patient satisfaction using the Visual Analogue Scale (VAS), quality of life, and return to daily activities. Incidence of Chronic Pain Syndrome (CPS), Type of anesthesia and ASA were evaluated and recorded. Computer-assisted measurement of antero-posterior radiographs was taken pre-operatively, as well as at 3 and 12 months after surgery and at 48-month follow-up, analysing the intermetatarsal angle (IMA), the hallux valgus angle (HVA), the distal metatarsal articular angle (DMAA), and the tibial sesamoid position. Also, the bridging bone/callus formation was evaluated at the different radiographic follow-ups, while the articular surface congruency and the metatarsal index were calculated only preoperatively and at last follow-up. Statistical analysis was carried out using the paired t-test. Statistical significance was set at p \< 0.05.

Conditions

• Hallux Valgus

Interventions

Type	Name	Description
PROCEDURE	Reverdin-Isham Osteotomy	Incision on the medial part of the foot, a Shannon Isham burr was introduced at the junction of metaphysis and epiphysis. It was applied to the flat bone surface achieved previously at approximately 45°, keeping the articular cartilage surface of the first metatarsal head as reference point on the superior cortex. In this position, under fluoroscopic control, the osteotomy was started following a distal-dorsal and proximal-plantar direction. At this point, the burr was slightly withdrawn in order to preserve a few millimetres of the lateral cortex, and the osteotomy of the plantar cortex was performed completely. Then, a Wedge burr was used to create a wedge with a medially oriented base. At the point of closing the wedge, osteoclasis of the preserved lateral cortex was achieved, modifying the orientation of the articular surface, normalizing the DMAA value, and adding an intrinsic stability to the osteotomy by producing contact of the trabecular bone.

Timeline

• Start date: 2010-05-01
• Primary completion: 2020-06-01
• Completion: 2021-03-01
• First posted: 2016-09-01
• Last updated: 2021-05-27

Locations

1 site across 1 country: Italy