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

Not Applicable

Completed

• Conditions: Hallux Valgus
• Interventions: Procedure: Reverdin-Isham Osteotomy

• Registration Number: NCT02886221
• Lead Sponsor: University of Padova

Brief 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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-09-01
• Primary Completion: 2020-06
• Study Completion: 2021-03
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Patients with mild to severe symptomatic hallux valgus

Exclusion criteria:

• congenital deformities of the foot
• hallux rigidus
• previous first ray trauma or foot and ankle surgery
• rheumatic, dismetabolic, neurologic, infective, or psychiatric pathologies.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HV patients	Reverdin-Isham Osteotomy	patients with symptomatic Hallux Valgus treated my Reverdin-Isham Osteotomy

Primary Outcome Measures

Name	Time	Method
clinical changes after surgical treatment	preoperative and at 3-12-48 months post-operative	evaluation scale: AOFAS score

Secondary Outcome Measures

Name	Time	Method
radiological changes after surgical treatment	preoperative and at 3-12-48 months post-operative	evaluation of the Intermetatarsal angle(IMA) of the first ray, distal metatarsal articular angle of the first metatarsal (DMAA), hallux valgus angle (HVA) and tibial sesamoid position
Postoperative pain levels and incidence of Chronic Pain Syndrome (CPS)	Patients were evaluated prospectively at 7 days, 1, 3 and 6 months after surgery for pain at rest and during movement.	The 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.

Trial Locations

Locations (1)

Carlo Biz MD; 🇮🇹 Padova, PD, Italy